A Six-Week Clinical Study to Determine the Effectiveness of a Hair …€¦ · Subjective questionnaire Reduces water loss of scalp TEWL Improves scalp hemoglobin (i.e. oxygenation)

International Research Services, Inc.

CLINICAL RESEARCH REPORT

A Six-Week Clinical Study to Determine the Effectiveness of a Hair Care Regimen

Protocol Number: 4141SH0617

Sponsor: Spare My Hair Soliman Care

Issued To: Shahinaz Soliman MD Soliman Care 3445 Pacific Coast Highway Suite 200 Torrance, CA 90505 Phone: 310.530.7244 E-Mail: [email protected]

Date of Issue: October 26, 2017

Study Site:

International Research Services, Inc. 222 Grace Church Street Port Chester, NY 10573 Phone: 914.937.6500 Fax: 914.937.8067

Principal Investigator:

Stephen R. Schwartz IRSI President, CEO E-Mail: [email protected]

Study Coordinator:

Anna Gafner E-Mail: [email protected]

Study Schedule Initiation: Baseline July 11, 2017

Completion: Week 6 August 22, 2017

Product: Spare My Hair Shampoo #00854246006001; Spare My Hair Conditioner #00854246006018; Spare My Hair Scalp Solution #00854246006032; Spare My Hair Vitamins #00854246006025; Shantique Laser Hair Brush #00854246006049

IRSI, Inc. Protocol No. 4141SH0617 FINAL Report Ver. 2.0 October 26, 2017

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Study Summary

Title A Six-Week Clinical Study to Determine the Effectiveness of a Hair Care Regimen

Protocol Number 4141SH0617

Sponsor Spare My Hair Soliman Care

Methodology Monadic

Objective To determine the efficacy of a hair care regimen to improve scalp condition as well as the appearance and strength of hair when used by a panel of male and female subjects for six weeks.

Number of Subjects 30 to complete, target enrollment 34

Target Population Male and Female subjects (approximately 50% each), age 25-65 years old

Duration Six weeks (Baseline, Week 6)

Claims Claim Support

Improves hydration of the scalp Corneometer Subjective questionnaire

Reduces water loss of scalp TEWL

Improves scalp hemoglobin (i.e. oxygenation) SIAscope

Improves the appearance of hair shine/luster, fullness (volume), softness, and scalp health

Visual grading Subjective questionnaire

Improves scalp skin pH pH Meter

Reduction of hair loss in shower and in brush/comb Subjective questionnaire

Study Product Name Formula Number

Spare My Hair Shampoo 00854246006001

Spare My Hair Conditioner 00854246006018

Spare My Hair Scalp Solution 00854246006032

Spare My Hair Vitamins 00854246006025

Shantique Laser Hair Brush 00854246006049

Statistical Methodology

Descriptive statistics reported, change from Baseline monadic: Paired T-test; mean at time interval compared to baseline, mean percent change compared to baseline. All final statistical analyses will be performed on the PP population. Statistical significance determined at p≤0.05.

Study Schedule Initiation Baseline July 11, 2017

Completion Week 6 August 22, 2017

Summary

This was a six-week, monadic evaluation of the effects of a regimen on the condition and appearance of hair and scalp. A study panel of 32 subjects was enrolled in the study and 30 completed participation.

Under the conditions of this study, use of Spare My Hair Shampoo #00854246006001; Spare My Hair Conditioner #00854246006018; Spare My Hair Scalp Solution #00854246006032; Spare My Hair Vitamins #00854246006025; Shantique Laser Hair Brush #00854246006049 led significant improvements in hair and scalp appearance, as evidenced by results from expert clinical grading and subjective questionnaire results. See Section 20.0 Conclusion for further detail.


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Table of Contents

1.0 Introduction ............................................................................................................................................ 5

2.0 Objectives................................................................................................................................................ 5

3.0 Study Design ............................................................................................................................................ 5

4.0 Product .................................................................................................................................................... 6

5.0 Population ............................................................................................................................................... 7

6.0 Methods .................................................................................................................................................. 8

7.0 Procedure .............................................................................................................................................. 11

8.0 Concomitant Medications and Products .............................................................................................. 13

9.0 Adverse Events ...................................................................................................................................... 13

10.0 Institutional Review Board .................................................................................................................. 14

11.0 Informed Consent ............................................................................................................................... 15

12.0 Discontinuation of Study ..................................................................................................................... 15

13.0 Changes to the Protocol ...................................................................................................................... 15

14.0 Monitoring .......................................................................................................................................... 16

15.0 Recording of Data ............................................................................................................................... 16

16.0 Quality Control and Quality Assurance ............................................................................................... 16

17.0 Ethics ................................................................................................................................................... 16

18.0 Statistical Methods ............................................................................................................................. 16

19.0 Results ................................................................................................................................................. 17

20.0 Conclusion ........................................................................................................................................... 17

Appendices Appendix I Protocol Appendix II Data Listing and Statistical Report


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List of Abbreviations

AE Adverse Event BL Baseline C Collect CRFs Case Report Forms D Dispense D0 Day 0 (Baseline) FDA Federal Drug Administration ICF Informed Consent Form ICH International Conference on Harmonization IRSI International Research Services, Inc. n Number of Subjects PI Principal Investigator PP Per protocol SAE Serious Adverse Event SOP Standard Operating Procedure Sponsor Spare My Hair, Soliman Care W6 Week 6


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1.0 Introduction

This document is a report for a human research study. This study was conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.

2.0 Objectives

2.1 Primary Objective

To evaluate the effectiveness of a hair care regimen in the improvement of hair and scalp condition and appearance after repeated use.

3.0 Study Design

This was a six-week, monadic evaluation of hair care regimen’s ability to improve hair and scalp condition and appearance. All subjects used the regimen for six weeks. Subjects underwent expert clinical visual grading of hair and scalp at study visits in addition to instrumental assessments of the scalp. Additionally, subjects completed subjective questionnaires, indicating their perception of the products and their effects. Thirty subjects completed study participation.

Study visits occurred at Baseline and Week 6, with assessments prior to initial test product use (Baseline or BL) and after six weeks of repeated test product use (W6). A detailed outline of study visits appears in Section 7.0 of the protocol (see Appendix I).

3.1 Claims:

Assessment and questionnaire data were analyzed with particular regard to the following desired key product effects:

1. Improves hydration of the scalp, as determined by Corneometer and subjective questionnaire results.

2. Reduces water loss of scalp, as determined by VapoMeter measurements of TEWL.

3. Improves scalp hemoglobin (i.e. oxygenation), as determined by SIAScope measurements.

4. Improves the appearance of hair shine/luster, fullness (volume), softness and scalp health, as determined by expert clinical grading and subjective questionnaire results.

5. Improves scalp skin pH, as determined by pH meter measurements.

6. Reduction of hair loss in shower and in brush/comb, as determined by subjective questionnaire results.

4.0 Product

All products were provided by the Sponsor and were labeled with appropriate codes and proper use instructions. Support product(s) were provided by IRSI. Upon receipt, product was logged in and stored in a secure area. Within one month of issuance of the final signed report, unless otherwise instructed in


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writing, all test products, used and unused, will be destroyed and disposed of in accordance with IRSI’s SOP.

4.1 Product Descriptions

Name Designation Formula Number Date

Received Quantity Received

Study Products

Spare My Hair Shampoo Shampoo 00854246006001 7/7/17 56

Spare My Hair Conditioner Conditioner 00854246006018 7/7/17 56

Spare My Hair Scalp Solution Scalp Treatment 00854246006032 7/7/17 40

Spare My Hair Vitamins Multivitamin 00854246006025 7/7/17 58

Shantique Laser Hair Brush Brush 00854246006049 7/7/17 40

4.2 Product Use Instructions

Study instructions were provided in writing and verbally explained to subjects.

Test Product Instructions:

Shampoo: Use at least three times per week and for any additional hair washing. Conditioner: Use after shampooing, at least three times per week. Scalp Solution: Apply to hair and scalp daily. Laser Hair Brush: Use three times per week (with the Scalp Solution). See Appendix for detailed instructions. Vitamins: Take three vitamins daily with a glass of water.

5.0 Population

5.1 Sample Size

The sample size of n=30 was requested by the Sponsor. A total number of 32 subjects were enrolled in the study and 30 completed study participation.

5.2 Inclusion Criteria

1. Males and Females (approximately 50% of each), in good general health.

2. Between ages of 25 and 65 years old, inclusive at enrollment

3. Multi-ethnic panel (Asian, Caucasian and Hispanic only), with at least one subject of each

ethnicity.

4. At least five subjects with dyed hair (self-applied or professional).

5. Able to read, understand and willing to follow study instructions, complete a brief

personal/medical history and sign an informed consent document.


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6. Subjects with widow’s peak or receding hairline (must have sufficient hairless scalp area to

apply measurement probes).

7. Willing to forego use of all hair products similar to study products, including shampoos,

conditioners, thickening and volumizing products, during the study period. Subjects are

allowed to style their hair as they normally would with usual products that are not for

thickening/volumizing.

8. Willing to arrive at the testing center for scheduled study visits having not used any hair

styling products on the day of each visit.

9. Willing to forego all swimming during study period.

5.3 Exclusion Criteria

1. Subjects currently using any hair thickening or hair growth treatments (ex. Rogaine).

2. Subjects with severely damaged, over-processed hair.

3. Subjects with scalp diseases or disorders.

General exclusion criteria:

4. Subjects participating in any other clinical studies.

5. Subjects having an acute or chronic disease or medical condition, including dermatological

problems, which could put the subject at risk in the opinion of the Principal Investigator or

compromise study outcomes. Typical uncontrolled chronic or serious diseases and

conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes

(insulin dependent), renal impairment, mental illness, drug/alcohol addiction.

6. Subjects who are unreliable or unlikely to be available for the duration of the study.

7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic

ingredients, toiletries, sunscreens, etc.

8. Immunocompromised subjects

9. Woman known to be pregnant, lactating or planning to become pregnant within six months.

Subjects who become pregnant during the study must inform the Principal Investigator

immediately

10. Individuals unable to communicate or cooperate with the Principal Investigator due to

language problems, poor mental development, or impaired cerebral function

11. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers

or suppliers

6.0 Methods

This study was performed in accordance to IRSI final signed clinical study protocol number 4141SH0617 version 2.0 dated July 7, 2017. A detailed description of study methods is outlined in the attached clinical study protocol (See Appendix I).


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7.0 Procedure

The three-visit clinical study included one visit for consenting, screening and qualification procedures and Baseline pre-application evaluations and a final visit at Week 6. A detailed description of procedures is outlined in the attached clinical study protocol (See Appendix I).

7.1 Procedure Summary Table

Procedures Baseline Week 6

Study Initiation and Qualification

Informed Consent and Medical History

X

Inclusion/Exclusion Criteria reviewed

X

Dispense/ Collect Products D

Product C

Product

Expert Clinical Grading

Hair shine/luster Hair fullness (volume) Hair Softness Scalp Health

X X

Instrumental Evaluation

Corneometer X X Vapometer X X pH Meter X X SIAscope X X

Consumer Perception

Subjective Questionnaire

X

8.0 Concomitant Medications and Products

The use of any hair care products similar to the test products including shampoos, dry shampoos, conditioners and scalp treatments was prohibited for the duration of the study period. Subjects were allowed continued use of their usual styling products (used for at least 2 weeks prior to Baseline) such as gel and hair spray. Hot styling tools were permitted for use.

Subjects were not allowed to cut their hair or chemically alter their hair in any way during the study duration including dying hair, chemically straightening or perming hair. Subjects were prohibited from introducing any new hair styling products for the duration of the study.

Subjects were not allowed to swim for the duration of the study.

9.0 Adverse Events

No adverse events were reported during the conduct of this study.

10.0 Institutional Review Board

IRB review and approval of this study was not requested by the Sponsor.


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11.0 Informed Consent

The informed consent process was completed prior to an individual’s involvement in any study related activity. The process was documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix I Protocol, Section 11.0 and Appendix IV).

After review, two copies of the ICF were signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy was retained by IRSI and the other was given to the individual.

12.0 Discontinuation of Study

Per protocol, the Sponsor had the option to end the study at eight weeks, or continue on to twelve weeks. The Sponsor chose to end the study after eight weeks.

13.0 Changes to the Protocol

13.1 Protocol Amendments

No amendments were made to the final study protocol.

13.2 Protocol Deviations

No protocol deviations occurred during the study.

14.0 Monitoring

The Sponsor did not monitor any portion of this clinical study.

15.0 Recording of Data

All data and information, except electronically recorded data, was recorded on specific paper case report forms (CRFs) as described in the clinical study protocol (See Appendix I Protocol, Appendix III).

16.0 Quality Control and Quality Assurance

This clinical study has been audited by the IRSI Quality Assurance / Quality Control auditor. The auditor verified study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. Additionally, accuracy of results reported in the body of this report with respect to the results reported in the data listings and statistical report (See Appendix III). The data listings and database used for statistical analysis was verified against the CRFs. The data listings were verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report was validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18 of the clinical study protocol.

17.0 Ethics

The study was conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This was not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.


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18.0 Statistical Methods

The planned statistical analysis was performed as outlined in the study protocol for each type of data to be acquired. (See Protocol, Section 18.0)

The per-protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject could not miss any study visit or be found to be non-compliant with the study protocol at the discretion of the Principal Investigator (PI).

The PP population was used for statistical analysis at each time point. Statistical significance was set at p≤0.05.

Data Type Statistical Method Data Reported

Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)

Clinical Grading for Efficacy, Instrumentation

Descriptive Statistics Paired T-test (monadic),

Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline

Subjective Questionnaire Descriptive Statistics

Frequency tables (n and %) of each response Percent of subjects responding favorably.


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19.0 Results

19.1 Tables

Enrollment and demographic information is reported below in Tables 1.0-2.0. Expert clinical grading results are included in Table 3.0, instrumental evaluation results are included in Table 4.0 and subjective questionnaire results are included in Tables 5.0-5.1.

Table 1.0 Enrollment Status n

Enrolled 32

Discontinued 2 Subject #29 voluntarily dropped from study at Week 6 and Subject #30 was lost to follow-up at week 6

Completed Baseline Time Point 30

Completed Week 6 Time Point 30

Table 2.0 Demographics

Variable n Mean ± SD Min Max

Age (years) 30 55.60 ± 8.34 37 65

Height (inches) 30 66.65 ± 4.13 61 74

Weight (pounds) 30 177.83 ± 45.19 112 270

n Percent

Sex 30 Female 16 53.3%

Male 14 46.7%

n Percent

Ethnicity 30 Hispanic or Latino 2 6.7%

Not Hispanic or Latino 28 93.3%

n Percent

Race 30

Asian 4 13.3%

White 25 83.3%

No Response See Hispanic or Latino above

1 3.3%

Subjects has dyed hair 30 Yes 30 100%

No 0 0.0%


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Table 3.0 Expert Clinical Grader Evaluation – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean

Percent of Subjects Showing

Improvement From BL

P-Value TX vs. BL

Hair Shine/Luster Baseline 30 1.95 ± 0.40

Week 6 30 2.65 ± 0.39 40.22% 93.3% <0.001*

Volume (Fullness) Baseline 30 2.13 ± 0.52

Week 6 30 2.48 ± 0.53 22.72% 66.7% 0.002*

Hair Softness Baseline 30 2.08 ± 0.39

Week 6 30 2.73 ± 0.41 36.72% 80.0% <0.001*

Scalp Health Baseline 30 2.68 ± 0.46

Week 6 30 2.96 ± 0.37 13.69% 40.0% 0.009* *Indicates a statistically significant improvement compared to baseline, p≤0.05

Table 4.0 Instrumental Evaluation – Monadic, Comparison to Baseline

Assessment Time Point n Mean ± SD Mean Percent Improvement From BL mean

Percent of Subjects Showing

Improvement From BL

P-Value TX vs. BL

SIAScope Hemoglobin Baseline 30 221.04 ± 21.32

Week 6 30 192.51 ± 28.59 NI 10.3% <0.001**

Corneometer Baseline 30 25.39 ± 19.32

Week 6 30 23.80 ± 18.23 29.40% 36.7% 0.632

Vapometer Baseline 30 22.15 ± 11.30

Week 6 30 13.31 ± 4.17 29.43% 96.7% <0.001*

PH Meter Baseline 30 5.72 ± 0.47

Week 6 30 5.21 ± 0.60 8.61% 76.7% <0.001* NI=No Improvement *Indicates a statistically significant improvement compared to baseline, p≤0.05 **indicates a statistically significant worsening compared to baseline, p≤0.05


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Table 5.0 Subjective Questionnaire – Consumer Perception

Question n

Week 6 Percent

Responding Favorably

Response n (%) Strongly

Agree Agree Neutral Disagree

Strongly Disagree

1. The test products improved hydration of the scalp.

30 5 (16.7%) 10 (33.3%) 13 (43.3%) 2 (6.7%) 0 (0.0%) 50.0%

2. The test products improved hair shine/luster.

30 1 (3.3%) 18 (60.0%) 6 (20.0%) 5 (16.7%) 0 (0.0%) 63.3%

3. The test products improved hair fullness (volume).

30 9 (30.0%) 10 (33.3%) 4 (13.3%) 7 (23.3%) 0 (0.0%) 63.3%

4. The test products improved hair softness.

30 6 (20.0%) 17 (56.7%) 3 (10.0%) 4 (13.3%) 0 (0.0%) 76.7%

5. The test products improved scalp health.

30 5 (16.7%) 3 (10.0%) 22 (73.3%) 0 (0.0%) 0 (0.0%) 26.7%

6. The test products reduced hair loss in shower.

30 4 (13.3%) 12 (40.0%) 7 (23.3%) 7 (23.3%) 0 (0.0%) 53.3%

7. The test products reduced hair loss in brush/comb.

30 5 (16.7%) 13 (43.3%) 7 (23.3%) 5 (16.7%) 0 (0.0%) 60.0%

8. I would purchase these products.

30 5 (16.7%) 7 (23.3%) 14 (46.7%) 3 (10.0%) 1 (3.3%) 40.0%

9. I would recommend these products to a friend.

30 5 (16.7%) 9 (30.0%) 8 (26.7%) 8 (26.7%) 0 (0.0%) 46.7%

Bold / Shaded = The majority of subjects responded favorably, >50%.


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Table 5.1 Subjective Questionnaire – Open Ended Responses

Question Open Ended Pooled Response Response

n (%)

10. What do you like about the products? N=30, some subjects gave multiple responses, responses =61

Scent/Smell/Fragrance 7 (11.5%)

Hair was softer 5 (8.2%)

The Lighted laser comb 5 (8.2%)

Hair was fuller 4 (6.6%)

Hair looked voluminous 4 (6.6%)

Easy to use/apply 4 (6.6%)

Hair was healthier 3 (4.9%)

Hair was shiny 2 (3.3%)

Hair looked thicker 2 (3.3%)

Reduced hair loss 2 (3.3%)

Would purchase/Like to have 2 (3.3%)

No Response/None 2 (3.3%)

Effective 2 (3.3%)

Conditioner 2 (3.3%)

Hair looked lustrous 1 (1.6%)

Scalp felt more hydrated 1 (1.6%)

Produced plenty of suds 1 (1.6%)

Product went a long way 1 (1.6%)

Was useful 1 (1.6%)

Hair was smooth 1 (1.6%)

Scalp spray 1 (1.6%)

Great experience 1 (1.6%)

Less hair in drain 1 (1.6%)

Helped hair growth 1 (1.6%)

Helped scalp health 1 (1.6%)

Hair was stronger 1 (1.6%)

Hair growth around hair line 1 (1.6%)

The spray 1 (1.6%)

The vitamins 1 (1.6%)

Table 5.1 Subjective Questionnaire – Open Ended Responses (Continued)

Question Open Ended Pooled Response Response

n (%)

11. What do you dislike about the products? N=30, some subjects gave multiple responses, responses =59

Took too much time/work 9 (15.3%)

Did not lather 7 (11.9%)

Fragrance/Perfume smell/Smell 6 (10.2%)

Shampoo is too thick 4 (6.8%)

No response/None/Nothing 3 (5.1%)

Hard to dispense 3 (5.1%)

Products too thick 3 (5.1%)

Conditioner is too thick 1 (1.7%)

Difficult to use 1 (1.7%)

Shampoo consistency 1 (1.7%)

Brush leaked solution 1 (1.7%)

Difficult to spread 1 (1.7%)

Brush had hard bristles 1 (1.7%)

Non-noticeable results 1 (1.7%)

Hair was dryer 1 (1.7%)

Vitamins too many times a day 1 (1.7%)

The spray 1 (1.7%)

Frizzy hair 1 (1.7%)

Solution ran down forehead 1 (1.7%)

Not long enough too see if hair grew 1 (1.7%)

No visible improvement 1 (1.7%)

Spray was greasy 1 (1.7%)

Scalp solution was sticky 1 (1.7%)

Lost volume from conditioner 1 (1.7%)

Conditioner made hair too soft 1 (1.7%)

Daily use made hair feel dirty 1 (1.7%)

Daily use made hair frizzy 1 (1.7%)

Shampoo not great 1 (1.7%)

Hard to rinse 1 (1.7%)

Little results 1 (1.7%)

Didn't help how I would like 1 (1.7%)


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19.2 Discussion

19.2.1 Enrollment and Demographics

A total of 30 male and female subjects, 25 to 65 years old, were required to complete study participation. The study completed with 30 subjects, 16 female and 14 male, with an age range of 37 to 65 with an average age of 55.60 years old. The population’s reported ethnicity was 93.3% Non-Hispanic or Latino and 6.7% Hispanic/Latino, and its reported racial diversity was 83.3% White, 13.3% Asian and 3.3% No Response (Hispanic/Latino). One Hundred Percent of the subjects had dyed hair.

19.2.2 Expert Clinical Grading

Comparison of mean results from Baseline to those at Week 6 revealed statistically significant improvements in the appearance of hair shine/luster, volume (fullness), hair softness and scalp health.

19.2.3 Instrumental Assessments

Statistically significant improvement from Baseline was observed after six weeks of regimen use in mean results for skin’s moisture barrier function, as evidenced by Vapometer TEWL assessments as well as in reduction in pH.

No significant difference was observed in Corneometer measurements of scalp moisture content, and a significant decrease in scalp hemoglobin was observed via SIAScope measurements.

19.2.4 Subjective Questionnaire

After six weeks of test regimen use, a majority of subjects (>50%) responded “Agree” or “Strongly Agree” to five out of nine queried statements, with strongest indications that the regimen improved hair softness, shine/luster and fullness (volume).

20.0 Conclusion

In conclusion, under the conditions of this study, use of Spare My Hair Shampoo #00854246006001; Spare My Hair Conditioner #00854246006018; Spare My Hair Scalp Solution #00854246006032; Spare My Hair Vitamins #00854246006025; Shantique Laser Hair Brush #00854246006049 led to significant improvements in hair’s appearance, as evidenced by results from expert clinical grading and subjective questionnaire, in scalp appearance and condition, as evidenced by results from expert clinical grading, VapoMeter and pH meter assessments.

Expert clinical grading revealed statistically significant improvements in the appearance of hair shine/luster, volume (fullness), hair softness and scalp health, after six weeks of use.

After six weeks of regimen use Vapometer assessment results revealed a statistically significant decrease in trans-epidermal water loss, indicating an augmented moisture barrier and a decrease in scalp pH was observed.

Subjective questionnaire results revealed that the majority of subjects believed that test product use improved hair shine/luster, fullness (volume) and softness and that the test regimen reduced hair loss in the shower and on the brush/comb.


CONFIDENTIAL Appendix I

Appendix I

Protocol

IRSI, Inc. Protocol No. 4141SH0617 FINAL Protocol Ver.2.0 July 7, 2017

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Study Summary

Title A Six-Week Clinical Study to Determine the Effectiveness of a Hair Care Regimen

Protocol Number 4141SH0617

Sponsor Spare My Hair Soliman Care

Methodology Monadic

Objective To determine the efficacy of a hair care regimen to improve scalp condition as well as the appearance and strength of hair when used by a panel of male and female subjects for six weeks.

Number of Subjects 30 to complete, target enrollment 34

Target Population Male and Female subjects (approximately 50% each), age 25-65 years old

Duration Six weeks (Baseline, Week 6)

Claims Claim Support

Improves hydration of the scalp Corneometer Subjective questionnaire

Reduces water loss of scalp TEWL

Improves scalp hemoglobin (i.e. oxygenation) SIAscope

Improves the appearance of hair shine/luster, fullness (volume), softness, and scalp health

Visual grading Subjective questionnaire

Improves scalp skin pH pH Meter

Reduction of hair loss in shower and in brush/comb Subjective questionnaire

Study Product Name Formula Number

Spare My Hair Shampoo 00854246006001

Spare My Hair Conditioner 00854246006018

Spare My Hair Scalp Solution 00854246006032

Spare My Hair Vitamins 00854246006025

Shantique Laser Hair Brush 00854246006049

Statistical Methodology

Descriptive statistics reported, change from Baseline monadic: Paired T-test; mean at time interval compared to baseline, mean percent change compared to baseline. All final statistical analyses will be performed on the PP population. Statistical significance determined at p≤0.05.

Study Schedule Initiation Baseline July 11, 2017


Final Topline Week 6 September 6, 2017

Draft Final Report: September 28, 2017

*Deliverable dates may shift +/- two (2) business days.


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Table of Contents

1.0 Introduction ...................................................................................................................................... 5

2.0 Objectives.......................................................................................................................................... 5

3.0 Study Design...................................................................................................................................... 5

4.0 Products ............................................................................................................................................ 6

5.0 Population ......................................................................................................................................... 6

6.0 Methods ............................................................................................................................................ 8

7.0 Procedure ........................................................................................................................................ 11

8.0 Concomitant Medications and Products ........................................................................................ 12

9.0 Adverse Events ................................................................................................................................ 12

10.0 Institutional Review Board .............................................................................................................. 14

11.0 Informed Consent ........................................................................................................................... 14

12.0 Discontinuation of Study ................................................................................................................. 14

13.0 Changes to the Protocol .................................................................................................................. 14

14.0 Monitoring ...................................................................................................................................... 15

15.0 Recording of Data ........................................................................................................................... 15

16.0 Quality Control and Quality Assurance ........................................................................................... 15

17.0 Ethics ............................................................................................................................................... 15

18.0 Statistical Methods ......................................................................................................................... 15

19.0 Reporting of Results ........................................................................................................................ 16

20.0 Record Retention ............................................................................................................................ 16

21.0 Publication Policy ............................................................................................................................ 16

22.0 References ...................................................................................................................................... 17

Appendices Appendix I Subject Instructions and Diary Appendix II Case Report Forms Appendix III Subjective Questionnaire Appendix IV Informed Consent Appendix V Laser Hair Brush Instructions


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List of Abbreviations

AE Adverse Event BL Baseline C Collect CRFs Case Report Forms D Dispense D0 Day 0 (Baseline) FDA Federal Drug Administration ICF Informed Consent Form ICH International Conference on Harmonization IRSI International Research Services, Inc. n Number of Subjects PI Principal Investigator PP Per protocol SAE Serious Adverse Event SOP Standard Operating Procedure Sponsor Spare My Hair, Soliman Care W6 Week 6


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1.0 Introduction

This document is a protocol for a human research study. This study will be conducted according to International Research Services, Inc. research policies and Standard Operating Procedures, U.S. and international standards of Good Clinical Practice (FDA and ICH guidelines) and applicable government regulations.

1.1 Background

The appearance of hair, including length, color and style impacts a person’s physical appearance and self-perception, and can have major social implications.1 The hair care market is second only to skin care, led by shampoos and conditioners.2 Many consumer perceivable benefits such as shine, frizz control, volume, softness and smoothness can be enhanced by cleansing and styling products. Shiny hair is often cited by consumers as one of the most desirable cosmetic attributes, as it is often associated with youthful, healthy hair.3, 4

Spare My Hair/ Soliman Care (Sponsor) has developed a hair care regimen intended to improve hair and scalp condition and appearance, and has contracted with International Research Services, Inc. (IRSI) to determine the actual effect of this product after initial application and after repeated applications per Sponsor instructions over four weeks.

2.0 Objectives

2.1 Primary Objective

To evaluate the effectiveness of a hair care regimen in the improvement of hair and scalp condition and appearance after repeated use.

3.0 Study Design

This is a six-week, monadic evaluation of hair care regimen’s ability to improve hair and scalp condition and appearance. All subjects will use the regimen for six weeks. Subjects will undergo expert clinical visual grading of hair and scalp at study visits in addition to instrumental assessments of the scalp. Additionally, subjects will indicate their perception of the products and their effects via subjective questionnaire completion. At least 30 subjects are expected to complete study participation.

Study visits will occur at Baseline and Week 6, with assessments prior to initial test product use (Baseline or BL) and after six weeks of repeated test product use (W6). A detailed outline of study visits appears in Section 7.0.

3.1 Claims:

Assessment and questionnaire data will be analyzed with particular regard to the following desired key product effects:

1. Improves hydration of the scalp, as determined by Corneometer and subjective questionnaire results.

2. Reduces water loss of scalp, as determined by VapoMeter measurements of TEWL.

3. Improves scalp hemoglobin (i.e. oxygenation), as determined by SIAScope measurements.


CONFIDENTIAL 6

4. Improves the appearance of hair shine/luster, fullness (volume), softness and scalp health, as determined by expert clinical grading and subjective questionnaire results.

5. Improves scalp skin pH, as determined by pH meter measurements.

6. Reduction of hair loss in shower and in brush/comb, as determined by and subjective questionnaire results.

4.0 Products

All study products will be provided by the Sponsor and will bear appropriate coding labels and proper use instructions. Products will be stored in a secure location and unused products will be returned to Sponsor or discarded upon issue of final report in accordance with IRSI’s Standard Operating Procedure (SOP).

4.1 Product Descriptions

Name Designation Formula Number

Study Products

Spare My Hair Shampoo Shampoo 00854246006001

Spare My Hair Conditioner Conditioner 00854246006018

Spare My Hair Scalp Solution Scalp Treatment 00854246006032

Spare My Hair Vitamins Multivitamin 00854246006025

Shantique Laser Hair Brush Brush 00854246006049

4.2 Product Use Instructions

Study instructions, will be provided in writing and verbally explained to subjects.

Test Product Instructions:

Shampoo: Use at least three times per week and for any additional hair washing. Conditioner: Use after shampooing, at least three times per week. Scalp Solution: Apply to hair and scalp daily. Laser Hair Brush: Use three times per week (with the Scalp Solution). See Appendix for detailed instructions. Vitamins: Take three vitamins daily with a glass of water.

5.0 Population

5.1 Sample Size

The sample size of n=30 was requested by the Sponsor.


CONFIDENTIAL 7

A sufficient number of subjects will be enrolled in order to complete this study with no less than 30 subjects. The target enrollment is 34 total subjects.

5.2 Inclusion Criteria

1. Males and Females (approximately 50% of each), in good general health.

2. Between ages of 25 and 65 years old, inclusive at enrollment

3. Multi-ethnic panel (Asian, Caucasian and Hispanic only), with at least one subject of each

ethnicity.

4. At least five subjects with dyed hair (self-applied or professional).

5. Able to read, understand and willing to follow study instructions, complete a brief

personal/medical history and sign an informed consent document.

6. Subjects with widow’s peak or receding hairline (must have sufficient hairless scalp area to

apply measurement probes).

7. Willing to forego use of all hair products similar to study products, including shampoos,

conditioners, thickening and volumizing products, during the study period. Subjects are

allowed to style their hair as they normally would with usual products that are not for

thickening/volumizing.

8. Willing to arrive at the testing center for scheduled study visits having not used any hair

styling products on the day of each visit.

9. Willing to forego all swimming during study period.

5.3 Exclusion Criteria

1. Subjects currently using any hair thickening or hair growth treatments (ex. Rogaine).




4. Subjects participating in any other clinical studies.



compromise study outcomes. Typical uncontrolled chronic or serious diseases and

conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes

(insulin dependent), renal impairment, mental illness, drug/alcohol addiction.

6. Subjects who are unreliable or unlikely to be available for the duration of the study.

7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic

ingredients, toiletries, sunscreens, etc.



Subjects who become pregnant during the study must inform the Principal Investigator

immediately


CONFIDENTIAL 8

10. Individuals unable to communicate or cooperate with the Principal Investigator due to

language problems, poor mental development, or impaired cerebral function

11. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers

or suppliers

6.0 Methods

6.1 Clinical Grading Assessments for Efficacy

Ordinal scales allow a number to be directly and objectively attached to the quality of a given attribute. When responding to an ordinal scale item, the grader specifies their level of agreement to a statement by choosing a set grade, or level.

The following IRSI-developed five-point ordinal scales will be used at Baseline, and Week 6. The grader will evaluate dry hair in static and dynamic states (visual and tactile) and will provide one grade for each of the following attributes: hair shine/luster, fullness/volume, softness and scalp health. Half points may be assessed as necessary by the grader. The grader will not have access to the Baseline grades when grading subsequent time points. For all scales, 0 = Worst possible condition, 4 = Best Possible Condition.

Hair Shine/ Luster

0 None Dull, matte appearance

0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5

4 Extreme High gloss, luster

Volume (fullness)

0 None Thin, closely follows shape of skull

0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5

4 Extreme Thick, bulky, high elevation from skull and lateral displacement


CONFIDENTIAL 9

Hair Softness

0 None Rough, coarse hair

0.5

1

1.5

2

2.5

3

3.5

4 Extreme Smooth, soft hair

Scalp Health

0 None Rough, flaking, plaques, cracked and/or reddened appearance

0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5

4 Extreme Smooth, intact, even-toned appearance

6.2 Instrumental Assessments

Test environment temperature (°F) and humidity (%) will be recorded in every room used for study conduct every hour. Additionally, once-daily outdoor conditions will be recorded for each visit.

6.2.1 Corneometer

The Corneometer CM 820 (Courage + Khazaka, Germany) measures the relative degree of hydration of the skin surface by applying an alternating current to the skin with a closely spaced pair of electrodes and measuring the capacitance. Changes in water content of the skin change the conductance of the capacitive circuit.

The Corneometer is able to detect slight changes in the hydration level reproducibly with a measurement time of only about one second. The measurement depth is small (approximately 10-20 µm of stratum corneum) which ensures assessment is not influenced by deeper skin layers.

Corneometer measurements will be captured in triplicate (and averaged) on the scalp, in a thinning spot or widow’s peak to ensure contact with the scalp skin. Measurements will be captured on the same location at BL and W6 and will be marked on a scalp map.

6.2.2 Vapo Meter

The VapoMeter (Delfin Technologies Ltd., Finland) measures the trans-epidermal water loss (TEWL) of the skin with a closed cylindrical chamber which contains sensors for relative humidity and temperature. Surface water is a function of water lost through the epidermis


CONFIDENTIAL 10

which provides an indication of the integrity of the skin barrier present in the stratum corneum. Changes in TEWL rates provide a measure of barrier disruption or integrity, thereby providing an indication of product performance.

When the VapoMeter is in contact with the skin or other measured surface, the relative humidity (RH%) in the chamber begins to increase. The TEWL value is calculated from the information the instrument acquires based on this increase. The measurement range for the VapoMeter is from 3 to 200 g/m²h, the closed chamber allows for accuracy of measurement range in these high values.

VapoMeter measurements will be captured in duplicate (and averaged) on the scalp, in a thinning spot or widow’s peak to ensure contact with the scalp skin. Measurements will be captured on the same location at BL and W6 and will be marked on a scalp map.

6.2.3 pH Meter

The Hanna HI98109 Skincheck Skin and Scalp pH meter is an electronic instrument used for measuring the pH (i.e. acidity or alkalinity) of the skin. This pH meter consists of a special measuring probe (a glass electrode) connected to an electronic meter that measures and displays the pH reading. The pH probe measures pH as the activity of the hydrogen ions surrounding a thin-walled glass bulb at its tip. The probe produces a small voltage (0.06 volt per pH unit) that is measured and displayed as pH units by the meter.

pH Meter measurements will be captured on the scalp, in a thinning spot or widow’s peak to ensure contact with the scalp skin. Measurements will be captured on the same location at BL and W6 and will be marked on a scalp map.

6.2.4 COSMETRICS™ SIAscope

The COSMETRICS™ SIAScope (Astron Clinica, Toft, UK) is a non-invasive optical skin imaging instrument using Spectrophotometric Intracutaneous Analysis (SIA), or chromophore mapping. The technique is based on a unique combination of dermatoscopy and contact remittance spectrophotometry. The hardware consists of a hand-held imaging probe attached to a laptop computer. The unit is placed in contact with the skin surface and high-intensity LED’s illuminate the skin as discreet wavelengths of 400 to 1000nm, spanning the visible spectrum and a small range of the near infrared spectrum. A digital image is captured for each wavelength.

SIAScope measurements for hemoglobin will be captured in duplicate on the scalp, in a thinning spot or widow’s peak to ensure contact with the scalp skin. Measurements will be captured on the same location at BL and W6 and will be marked on a scalp map.

6.3 Subjective Questionnaire

Subjective questionnaires will be used to gauge the subject’s perception of the product after six weeks of use. Questions will ask for subjects’ responses for subjects’ agreements to a statement with a five point scale. IRSI will provide questionnaire, Sponsor will confirm questions prior to protocol finalization.


CONFIDENTIAL 11

7.0 Procedure

7.1 Baseline

Potential subjects will come to the clinic having washed their hair within the past 24 hours and allowed it to dry completely, styled in usual manner with simple hair down style with no styling products.

Potential subjects will read and sign an informed consent form (ICF), as described in Section 11, inclusion / exclusion criteria and to complete a brief personal/medical history. The following Screening procedures will be performed and all findings will be reported on the

appropriate CRFs: - Potential subjects will be screened for qualification using an Inclusion/Exclusion

criteria checklist. Subjects that meet entrance criteria as defined in Section 5.2 and 5.3 will be enrolled in the

study and proceed with study participation. The following Baseline assessments will be performed and all findings will be reported on the

appropriate CRFs: - Clinical Grading Assessments for Efficacy as described in Section 6.1 - Instrumental Assessments as described in Section 6.2

All subjects will receive the test product, instructions and an application diary. Subjects will be advised to immediately report any adverse reactions or experiences

immediately to IRSI. They will be given an appointment time for their Week 6 visit and will be dismissed from the Baseline visit.

7.2 Week 6

Subjects will arrive at the study site (IRSI) having washed their hair within the past 24 hours and allowed it to dry completely, styled in usual manner with simple hair down style with no styling products.

Subjects’ used and remaining unused product and daily diary will be collected and reviewed for compliance and for indications of changes in subjects’ health.

The following assessments will be performed and all findings will be reported on the appropriate CRFs: - Clinical Grading Assessments for Efficacy as described in Section 6.1. - Instrumental Assessments as described in Section 6.2 - Subjective questionnaire as described in Section 6.3

After all evaluations are completed, subjects will be given a stipend for their participation and dismissed from the study.


CONFIDENTIAL 12

7.3 Procedure Summary Table

Procedures Baseline Week 6

Study Initiation and Qualification

Informed Consent and Medical History

X

Inclusion/Exclusion Criteria reviewed

X

Dispense/ Collect Products D

Product C

Product

Expert Clinical Grading

Hair shine/luster Hair fullness (volume) Hair Softness Scalp Health

X X

Instrumental Evaluation

Corneometer X X

Vapometer X X

pH Meter X X

SIAscope X X

Consumer Perception


X

8.0 Concomitant Medications and Products

The use of any hair care products similar to the test products including shampoos, dry shampoos, conditioners and scalp treatments is prohibited for the duration of the study period. Subjects may continue the use of their usual styling products (used for at least 2 weeks prior to Baseline) such as gel and hair spray.

Subjects may not cut their hair, chemically alter their hair in any way during the study duration including dying hair, chemically straightening or perming hair. Subjects may not introduce any new hair styling products for the duration of the study, they must have used the styling product / method (tools) for at least two weeks prior to Baseline. Hot styling tools are permitted for use.

Subjects may not swim for the duration of the study.

9.0 Adverse Events

Subjects will be advised to report all adverse events to the study personnel as soon as possible. An adverse event (AE) is any untoward medical occurrence experienced by a subject whether or not considered product related.

An adverse event must have an onset time after the subject is enrolled in the study and generally within one week after the subject's participation in the study has ended. The endpoint will depend on the nature of the product being tested.

An adverse event may consist of a:

Disease or injury Exacerbation of pre-existing illness or condition Recurrence of an intermittent illness or condition Set of related signs or symptoms Single sign or symptom


CONFIDENTIAL 13

Adverse events will be recorded on the appropriate case report form and include the Principal Investigator's assessment of product relationship as follows:

0 = None 1 = Remote 2 = Possible 3 = Probable 4 = Definite

The Principal Investigator's assessment will be summarized in the final report.

9.1 Serious Adverse Events

A serious adverse event will be defined as any experience which is (any one or more of the following):

Fatal Life-threatening Persistent or significant disability/incapacity Required or prolongs inpatient hospitalization Results in congenital anomaly or birth defect

9.2 Reporting of Adverse Events

Adverse events will be documented on the appropriate form and reported to the Sponsor within five business days if any relationship to the product(s) is determined by the Principal Investigator (PI). The Sponsor will be notified of any serious adverse event (SAE) within 24 hours of recording the experience (when possible). Additionally, all AEs, serious / not serious, related / not related will be summarized in the final report and a copy of the AE form will be appended to the final report. Proper judgment will be exercised in deciding whether expedited reporting is appropriate in other situations, such as events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also usually be considered serious (FDA 21 CFR., Vol. 62, No. 194, 52243). Examples are:

Overdose Intensive treatment in an emergency room or at home for allergic bronchospasm Development of drug dependency or drug abuse

Sponsor Contact for Reporting AEs and SAEs Contact: Shahinaz Soliman MD Address: 3445 Pacific Coast Highway, Suite 200, Torrance, CA 90505 Phone: 310.530.7244 E-Mail: [email protected]

IRSI, IRSI staff and its Investigators do not assume Sponsor obligations for reporting SAEs to the FDA or other regulatory agencies.


CONFIDENTIAL 14

10.0 Institutional Review Board

An Institutional Review Board was not requested by the study sponsor for this clinical study.

11.0 Informed Consent

The informed consent process will be completed prior to an individual’s involvement in any study related activity. The process will be documented using a written informed consent form (ICF) conforming to FDA 21 CFR 50.25 (See Appendix IV).

The study Principal Investigator or his designee will inform the individual of all aspects of the trial that are relevant to the subject’s decision to participate, and the individual will have the opportunity to have any questions answered. As part of the written consent, the subject will be informed that she has the right to discontinue participation in the study at any point. Subjects who are not capable of providing or are unwilling to provide voluntary informed consent will not be enrolled.

After review, two copies of the ICF will be signed and dated by the individual and the Principal Investigator or his designee administering the consent. One original copy will be retained by IRSI and the other will be given to the individual.

12.0 Discontinuation of Study

The Sponsor, Principal Investigator, and IRSI have the right to discontinue the study for medical, safety or administrative reasons at any time. Appropriate procedures will be followed to ensure the safe withdrawal of each subject from the study.

13.0 Changes to the Protocol

Upon Sponsor, Principal Investigator, and Study Coordinator approval and signing, this study protocol is considered final. Changes to the protocol must be approved in writing by the Sponsor and Principal Investigator prior to implementation. It is the responsibility of the Primary Investigator and Study Coordinator to ensure the protocol is approved and followed in agreement with FDA 21 CFR Part 58 Sec. 58.33.

Changes to the protocol will be categorized and documented as per IRSI’s SOP as follows: Protocol Amendment, Protocol Deviation: Major and Minor.

13.1 Protocol Amendments

A protocol amendment is any permanent change or written clarification to the study protocol. Amendments may be requested by the Sponsor, Principal Investigator or Study Coordinator.

Amendments to the protocol must be approved in writing by both the Principal Investigator and the Sponsor prior to implementation. The exception shall be when a change is required in the interest of subject protection or safety. In such instances, the sponsor shall be notified in writing within 24-hours of the change, whenever possible.

13.2 Protocol Deviations

A protocol deviation is any divergence or departure from the study protocol or a SOP. Deviations will be evaluated for significance and those that are categorized by the Study Coordinator as Major or Minor will be reported.


CONFIDENTIAL 15

A deviation is considered Major when there is a consistent variation in practice from the defined protocol or a subject has been identified as being at risk of harm in relation to their involvement in the study and urgent action, which deviates from the protocol, has occurred. Major deviations will be reported to the Sponsor within 24-hours (when possible) and corrective action (if necessary) will be identified.

A deviation is considered Minor when a variation to the protocol does not affect subject safety or the integrity of the research. Minor deviations will be documented throughout the study and reported to the Sponsor upon completion of the study.

14.0 Monitoring

IRSI will permit trial-related monitoring, audits, and regulatory inspections at any time. Access to all study documents, source documents and data will be available on site.

15.0 Recording of Data

All data and information, except electronically recorded data (Vapometer) will be recorded on specific paper case report forms (CRFs) and this information will be neatly recorded in type or legibly printed in black ink wherever possible (Appendix II). Any errors will be crossed out and the correct entry made and initialed and dated by the Principal Investigator or his designee, unless the CRF is also a source document completed by the subject (such as a questionnaire) in which case the correction will be made by the subject as described above.

16.0 Quality Control and Quality Assurance

IRSI will audit the study for accuracy, consistency and proper documentation in accordance to IRSI SOPs and practices. The auditor will verify the accuracy of results reported in the data listings and statistical analysis after each study visit. The data listings and database used for statistical analysis will be verified against the CRFs. The data listings will be verified against the CRFs for 100% of the data, in a randomly selected set of the subjects (25% of the total number of subjects). The statistical report(s) will be validated for accuracy and completeness, as well as verifying the correctness of all subject numbers (n) and the analyses performed according to the Statistical Analysis Plan as described in Section 18. The statistical topline tables will be reviewed and compared with the statistical report for accuracy.

17.0 Ethics

The study will be conducted in accordance with FDA GCP regulations and ICH guidelines in as much as they apply to cosmetic research with the following noted: This is not an IND / NDA clinical trial. IRSI does not assume any Sponsor obligations as stipulated in FDA GCP and ICH documents. This study is not intended for submission to the FDA.

18.0 Statistical Methods

The planned statistical analysis as requested by the Sponsor is outlined below for each type of data to be acquired.

The per protocol (PP) population is defined as the subset of subjects that who complied with the protocol sufficiently to ensure that their data will be likely to exhibit the effects of the treatment. To be considered a PP subject, a subject cannot miss any study visit or found to be non-compliant with the study protocol at the discretion of the Principal Investigator.


CONFIDENTIAL 16

The PP population will be used for statistical analysis at each time point.

Data Type Statistical Method Data Reported

Demographics Descriptive Statistics Mean and standard deviation Min and Max Frequency (number and percent)

Clinical Grading for Efficacy, Instrumentation

Descriptive Statistics Paired T-test (monadic),

Mean and standard deviation Mean percent improvement from Baseline Percent of subjects improving P-value vs. Baseline

Subjective Questionnaire Descriptive Statistics

Frequency tables (n and %) of each response Percent of subjects responding favorably.

19.0 Reporting of Results

A top line report (data only), will be issued electronically approximately ten business days after the Week 6 visit according to the dates indicated below.

The final draft report will be issued electronically approximately five weeks after study completion. Upon Sponsor approval of the draft, the report will be finalized. If no request for revisions or approval is received from the Sponsor within six weeks after the issuance of the draft report, it will be considered final. Once finalized, the report will be issued electronically via secure file share.

Schedule

Initiation: Baseline July 11, 2017


Deliverable Date of Expected Delivery*

Final Topline Week 6 September 6, 2016

Draft Final Report: September 28, 2016

*Deliverable dates may shift +/- two (2) business days.

20.0 Record Retention

IRSI shall assume the Principal Investigator responsibilities of maintaining study records for a period of two years following the date a marketing application is approved for the test material(s) for the indication for which it is being tested; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified, if required. Therefore, for this study, IRSI will archive the study records for a period of two years after the test is discontinued. Material may be archived in electronic or hard copy form. IRSI does not assume any sponsor obligation regarding record retention or notification/submission to FDA. Prior to study initiation the sponsor shall provide written notification to IRSI of any submissions to or approvals sought from FDA for the test materials being studied.

21.0 Publication Policy

Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the Sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the Sponsor. Conversely, prior to publication or other public presentation of the results from this clinical study, the Sponsor should obtain consent from the Primary Investigator.


CONFIDENTIAL 17

22.0 References 1 Trueb, RM, (2006) “Pharmacologic interventions in aging hair”, Clinical Interventions in Aging, 1 (2), 121-129.

2 “Hair Care in the US”, Euromonitor (October 2011) 3 Lim, JM, Chang, MY, Park, ME, Kwak, TJ, Kim, JJ, Lee, CK, (2006) “A study correlating between instrumental and consumers’ subjective luster values in oriental hair tresses”, Journal of Cosmetic Science, 57, 475-485

4 Reich, C, Robbins, CR, (1993), “Light scattering and shine measurements of human hair: a sensitive probe of the hair surface”, Journal of the Society of Cosmetic Chemists, 44, 221-234.


CONFIDENTIAL APPENDIX I

Appendix I

Subject Instructions and Daily Diary

DIARY AND USAGE INSTRUCTIONS

BASELINE THROUGH WEEK 6

Study Number: 4141SH0617

Subject Initials:

Subject Number:

SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY

• USE THE TEST PRODUCTS AS DIRECTED ON THE BACK OF THE DIARY

• CHECK OFF USE OF THE PRODUCTS EACH DAY

July 11 Shampoo Conditioner Scalp Solution Brush (with SS) Vitamins






















Subject Initials:

Subject Number:

SUNDAY MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY



August 1 Shampoo Conditioner Scalp Solution Brush (with SS) Vitamins





















August 22

WEEK 6 FINAL VISIT

Wash within 24 hours of visit




Subject Initials:

Subject Number:

REGIMEN INSTRUCTIONS:

Shampoo: Massage into wet hair and scalp. Rinse thoroughly. Repeat if necessary. Follow with conditioner. Use at least 3 times per week.

Conditioner: After shampooing, massage into hair focusing on ends. Rinse thoroughly. Use at least 3 times per week.

Scalp Solution: Apply directly to the scalp and massage gently. Use before styling, Do not rinse. Use daily without brush AND 3 times/week with Brush B.

Vitamins: Take three vitamins daily with food and water.

Laser Hair Brushes**:

Brush B: Use with the Scalp Solution 3 times per week.

• Using the pipette enclosed in your package, add the scalp solution to the opening on top of Brush B. Close the top and secure it tightly.

• Use Brush B on dry or wet hair, starting from the front of the scalp and moving half and inch backward every four seconds; use it on the entire scalp for a period that doesn’t exceed 10 to 15 minutes per session




Subject Initials:

Subject Number:

Brush A: Use immediately after Brush B.

• Immediately after using Brush B, use starting from the front of the scalp and moving half and inch backward every four seconds; use it on the entire scalp for a period that doesn’t exceed 10 to 15 minutes per session

**Battery charging: When charging, the red light will be on. When charging is complete, the green light will turn on.

RESTRICTIONS:

• DO NOT use any hair coloring or undergo any chemical hair treatment (s) for the duration of the study.

• DO NOT use any other hair care products similar to the test products, (shampoos, dry shampoos, conditioners, leave in conditioners).

• DO NOT introduce any new styling products or methods (tools) for the duration of the study.

Reminders for your next visit:

• Bring products and diary

• Wash within 24 hours of your visits and do apply any styling products

Call IRSI immediately if you experience any signs of irritation or with any questions or concerns.

• Anna, Study Coordinator: 914-937-6500 ext 126

• Reception Desk (during visits): 914-937-6500 ext 111

THANK YOU FOR YOUR PARTICIPATION


CONFIDENTIAL APPENDIX II

Appendix II

Case Report Forms

CASE REPORT FORM

Tracking Baseline

Study Number 4141SH0617

Subject Initials

Subject Number

Do not write below this line, for IRSI staff use only.

This CRF has been reviewed for completion prior to subject’s dismissal from study visit Tech Initials:

Baseline: Page 1 of 7 TOTAL: Page 1 of 13

Subject Signature:

Baseline: July 11, 2017 Tech Time

Arrive at site

Informed consent and medical history completed

Inclusion/Exclusion Criteria reviewed Circle One

YES NO

Clinical Grading Assessment (ordinal) Number of Assessments: 4

Instrumental Assessments: pH Meter

Instrumental Assessments: Vapo Meter

Instrumental Assessments: Corneometer

Instrumental Assessments: SIAscope

Dispense study product, instructions and application diary

All CRFs reviewed for completion, Subject scheduled for Week 6 appointment and dismissed from visit

CASE REPORT FORM

Medical History


Subject Initials

Subject Number




Please fill out the following form completely, if you need assistance please speak with an IRSI Technician.

Name: Last: First: MI: Date: / /

Height:

Ft. In.

Weight

Lbs.

Date of Birth:

Mo. Day Year

Age: Sex: Male Female

Ethnicity: Hispanic or Latino Not Hispanic or Latino

Race: American Indian or Alaska Native Asian (circle one: Far East, Southeast Asia, Indian subcontinent) Black or African American Native Hawaiian or Other Pacific Islander White Other____________

Facial Skin Type: Normal Oily Dry Combination

Body Skin Type: Normal Dry Very Dry

Fitzpatrick Skin Type: (see examples)

Type I Type IV

Type II Type V

Type III Type VI

Do you have Sensitive Skin? YES NO

Do you have Sensitive Eyes?

YES NO

Do you wear contact lenses? YES NO

Occupation: Retired Homemaker Unemployed Employed, Job Title: 1. Do you have any of the

following: Yes No

2. Have you had a reaction to any of the following:

Yes No

Asthma or emphysema Fragrances and Perfumes

Hay Fever or seasonal allergies Creams

Food allergies Moisturizers

Eczema or Psoriasis Soaps

Thyroid Problems Other body products

High Cholesterol Cosmetics

Diabetes, if yes: Sunscreens

A .Insulin Dependent NA If “yes” any of the above, please explain below:

B. Non-Insulin Dependent NA

Eye disease or condition

High Blood Pressure

Are you pregnant, nursing a child or planning on becoming pregnant during this study? Yes No NA 3. What method of birth control are you currently using?

Tubal Ligation NuvaRing Norplant

Hysterectomy Depo Provera Abstinence

Diaphragm Birth Control Pill Post-Menopausal

IUD Condom Other

List Medications taken within the past thirty (30) days. Please include prescription drugs, vitamins, skin treatments, herbal remedies, allergy medications, antihistamines, steroids, antibiotics, anti-inflammatory drugs, antacids, and contraceptives:

If no medications have been taken in the past thirty (30) days, check here

Medications

Name of Medication Dose Reason for taking Medication Date

Ongoing Start Stop

This form reflects all medical information up to the first day of this study. Notify our staff if there is any change in this information

Inclusion/Exclusion Baseline


Subject Initials

Subject Number



INCLUSION If any box is checked “No”, subject is NOT eligible to continue study. YES NO

1. Is the subject a male or female (approximately 50% of each), in good general health?

2. Is the subject between ages of 25 and 65, inclusive at enrollment?

3. Is the subject Asian, Caucasian or Hispanic (multi-ethnic panel including at least one subject of each ethnicity)?

4. Does the subject have dyed hair (self-applied or professional? At least 5 subjects required

5. Is the subject able to read, understand and willing to follow study instructions, complete a

brief personal/medical history and sign an informed consent document?

6. Does the subject have a widow’s peak or receding hairline (must have sufficient hairless scalp area to apply measurement probes)?

7.

Is the subject willing to forego use of all hair products other than the study products, including shampoos, conditioners, thickening and volumizing products during the study period? Subjects are allowed to style their hair as they normally would with usual products that are not for thickening/volumizing.

9. Is the subject willing to arrive at the testing center for scheduled visits having not used any hair styling products on the day of the visit?

10. Is the subject willing to forego all swimming during the study period?

EXCLUSION If any box is checked “Yes”, subject is NOT eligible to continue study. YES NO

1. Is the subject currently using any hair thickening or hair growth treatments (ex. Rogaine)?

2. Does the subject have severely damaged, over-processed hair?

3. Does the subject have scalp diseases or disorders?

4. Is the subject participating in any other clinical studies?

5.

Does the subject have an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study out comes. Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal impairment, mental illness, drug/alcohol addiction?

6. Is the subject unreliable or unlikely to be available for the duration of the study?

7. Does the subject have a history of allergic reactions, skin sensitization and/or know allergies to cosmetic ingredients, toiletries, sunscreens. etc.?

8. Is the subject Immunocompromised?

9. Is the subject a woman known to be pregnant, lactating or planning to become pregnant within six months? Subjects who become pregnant during the study must inform the Principal Investigator immediately?

10. Is the subject an individual unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function?

11. Is the subject an employee of IRSI or other testing firms/laboratories, cosmetic or raw goods manufacturers or suppliers?

Based on the above inclusion/ exclusion criteria, does the subject qualify?

Baseline: July 11, 2017 Tech

Inclusion / Exclusion criteria checklist

Expert Grader Assessments Baseline


Subject Initials

Subject Number



Hair Shine/Luster


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


Volume (fullness)


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


Hair Softness


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


BASELINE: July 11, 2017 Tech

Ordinal – Hair/Scalp No. of Assessments: 4

Expert Grader Assessments Baseline


Subject Initials

Subject Number



Scalp Health


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


Scalp Map


Subject Initials

Subject Number


This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials:

Baseline: Page 6 of 7


TOTAL: Page 6 of 13

Instructions: Using a ruler, identify the location where measurement will be taken. When possible at least two anatomical locations should be used to indicate the measurement location. The type of measurement should be clearly indicated

Marker Tech Instrument

* pH Meter

X Corneometer

+ Vapo Meter

# SIAscope

Instrumental Assessments

Baseline


Subject Initials

Subject Number



Baseline : Page 7 of 7


TOTAL: Page 7 of 13

Baseline: July 11, 2017 Tech PH Meter Single measurement on scalp

Test Site Location Scalp Wiping Performed: ☐ YES ☐ NO

Randomized NO Template Attached:

Scalp Map

pH Reading


Vapo Meter Duplicate measurements on scalp


Randomized NO Template Attached: Scalp Map

Vapo Meter measurements recorded using EDC.


Corneometer Triplicate measurements on scalp



Measurement 1 Measurement 2 Measurement 3 Average


SIAscope Duplicate measurements on scalp - Hemoglobin values recorded



Measurement 1 Mean: Std. Deviation:


Tracking

Week 6


Subject Initials

Subject Number



WEEK 6: Page 1 of 6


TOTAL: Page 8 of 13

Subject Signature:

WEEK 6: August 22, 2017 Tech Time

Arrive at site

Week 6 questionnaire completed and reviewed

Daily diary collected and reviewed, study product collected

Compliance check Subject Compliant?

Circle One

Yes No Medical History review, questioned for AEs

AE Reported? Circle One

Yes No

Clinical Grading Assessment (ordinal) Number of Assessments: 4

Instrumental Assessments: pH Meter

Instrumental Assessments: Vapo Meter

Instrumental Assessments: Corneometer

Instrumental Assessments: SIAscope

All CRFs reviewed for completion

Subject received stipend paid and dismissed from study

CASE REPORT FORM

Medical History and AEs Week 6


Subject Initials

Subject Number



WEEK 6: Page 2 of 6


TOTAL: Page 9 of 13

WEEK 6: August 22, 2017 Tech

Medical history and AEs

List any changes to medical history mentioned by the Subject, including but not limited to medications taken:

Any AEs or SAEs to report?

Circle One

Yes* No

*If yes, fill out AE form

CASE REPORT FORM

Compliance Week 6


Subject Initials

Subject Number



WEEK 6: Page 3 of 6


TOTAL: Page 10 of 13

Compliance If any box is checked “No”, subject is NOT eligible to continue study. YES NO

1.

Subject has arrived for Week 6 having washed their hair within the past 24 hours and allowed it to dry completely, styled in usual manner with simple hair down style with no styling products?

2. Subject used the test regimen as per study instruction?

3. Subject refrained from using any hair care products similar to the test products including shampoos, conditioners, dry shampoos, etc?

4. Subject refrained from chemically altering their hair in any way during the study duration, including dying hair, chemically straightening or perming hair?

5. Subject refrained from introducing new hair styling products for the duration of the study?

Based on the above questions, was the subject compliant?


Compliance (Applicable Inclusion / Exclusion) checklist

Expert Grader Assessments Week 6


Subject Initials

Subject Number



WEEK 6: Page 4 of 6



Hair Shine/Luster


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


Volume (fullness)


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


Hair Softness


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5



Ordinal – Hair/Scalp No. of Assessments: 4

Expert Grader Assessments Week 6


Subject Initials

Subject Number



WEEK 6: Page 5 of 6



Scalp Health


0.5

1 Slight

1.5

2 Mild

2.5

3 Moderate

3.5


CASE REPORT FORM

Instrumental Assessments Week 6


Subject Initials

Subject Number



Week 6: Page 6 of 6



WEEK 6: August 22, 2017 Tech PH Meter Single measurement on scalp



pH Reading


Vapo Meter Duplicate measurements on scalp



Vapo Meter measurements recorded using EDC.


Corneometer Triplicate measurements on scalp



Measurement 1 Measurement 2 Measurement 3 Average


SIAscope Duplicate measurements on scalp - Hemoglobin values recorded





Temperature and Humidity Log

FORM Number: 035 Version: Implementation Date: Theoretical Withdraw Date:

1.0 11/6/2013 11/6/2015

This CRF has been reviewed for completion prior to the completion of the visit Tech Initials _______ Tech Initials _______

Page 1 of 7

Instructions: Indoor temperature and humidity will be recorded every hour for studies involving temperature/humidity sensitive evaluations. For all studies, outdoor temperature and humidity conditions will be recorded each day and indoor temperature and humidity will be recorded at three time intervals, prior to first subject arrival/acclimation, halfway through the study visit, and upon completion of the study visit. A temperature and humidity log should be used for each room used in the study.


VISIT Baseline July 11, 2017

OUTDOOR CONDITIONS

TEMPERATURE (°F) HUMIDITY (%RH)

High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM: RECEPTION AREA DEVICE

NUMBER:

TIME TEMPERATURE (°F) HUMIDITY (%RH) TECHNICIAN

INITIALS



1.0 11/6/2013 11/6/2015


Page 2 of 7



INDOOR CONDITIONS

ROOM: VISUALS/pH METER DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 3 of 7



INDOOR CONDITIONS

ROOM: CORNEO/VAPOMETER DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 4 of 7



INDOOR CONDITIONS

ROOM: SIASCOPE/PRODUCT DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 5 of 7


VISIT Week 6 August 22, 2017

OUTDOOR CONDITIONS

TEMPERATURE (°F) HUMIDITY (%RH)

High: High:

Low: Low:

Average: Average:

Source:

INDOOR CONDITIONS

ROOM: RECEPTION AREA DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 6 of 7



INDOOR CONDITIONS

ROOM: VISUALS/pH METER/VAPOMETER DEVICE

NUMBER:


INITIALS



1.0 11/6/2013 11/6/2015


Page 7 of 7



INDOOR CONDITIONS

ROOM: SIASCOPE/CORNEO DEVICE

NUMBER:


INITIALS

Reimbursement Form


Subject Initials

Subject Number

PLEASE PRINT CLEARLY, FILL IN ALL FORM FIELDS DO NOT WRITE IN SHADED AREAS

- -

Social Security Number

First Name M.I. Last Name

Street Apt. /Suite

City / Town State Zip Code

414SH0617

$60.00

Department / Study Amount

Payment Terms: Please read ClinCard information. I_____________________________ have received my payment and agree to the ClinCard terms. Sign your name


CONFIDENTIAL APPENDIX III

Appendix III


CASE REPORT FORM

Subjective Questionnaire Week 6

August 22, 2017


Subject Initials

Subject Number


This CRF has been reviewed for completion prior to subject’s dismissal from station Tech Initials: Week 6

Page 1 of 3 This CRF has been reviewed for completion prior to subject’s dismissal from study visit

Tech Initials:

Please rate the level of agreement to the statements after using the test products for 6 Weeks. Use the rating scales provided below and be sure to answer every question. 1. The test products improved hydration of the scalp.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree

e. Strongly Disagree

2. The test products improved hair shine/luster. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


3. The test products improved hair fullness (volume). a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


4. The test products improved hair softness.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


Questionnaire continued on the next page

CASE REPORT FORM


August 22, 2017


Subject Initials

Subject Number




Tech Initials:

5. The test products improved scalp health. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


6. The test products reduced hair loss in shower. a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


7. The test products reduced hair loss in brush/comb.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


8. I would purchase these products.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


Questionnaire continued on the next page

CASE REPORT FORM


August 22, 2017


Subject Initials

Subject Number




Tech Initials:

9. I would recommend these products to a friend.

a. Strongly Agree

b. Agree

c. Neutral

d. Disagree


10. What did you like about the products?

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

11. What did you dislike about the products?

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________


CONFIDENTIAL APPENDIX IV

Appendix IV

Informed Consent Form

INFORMED CONSENT FORM Study Number: 4141SH0617

An Six-Week Clinical Study to Determine the Effectiveness of a Hair Care Regimen

Date of ICF Approval July 10, 2017

Subject Initials: _______

Page 1 of 6

This consent form may contain word(s) that you do not understand. Please ask the study staff to explain any word(s) or information that you do not clearly understand. You are entitled to a copy of this Consent Form and one will be provided to you today.

1.0 PURPOSE

You are being asked to participate in a research study to evaluate the ability of a hair care regimen to improve the appearance and condition of hair and scalp after repeated use.

2.0 ENROLLMENT

Certain enrollment criteria are required for this study. If you do not meet these criteria you will not be enrolled in this study. Below is a list of enrollment requirements. Inclusion Criteria

1. Males and Females (approximately 50% of each), in good general health. 2. Between ages of 25 and 65 years old, inclusive at enrollment 3. Multi-ethnic panel (Asian, Caucasian and Hispanic only), with at least one subject of each ethnicity. 4. At least five subjects with dyed hair (self-applied or professional) 5. Able to read, understand and willing to follow study instructions, complete a brief personal/medical

history and sign an informed consent document 6. Subjects with widow’s peak or receding hairline (must have sufficient hairless scalp area to apply

measurement probes). 7. Willing to forego use of all hair products similar to study products, including shampoos,

conditioners, thickening and volumizing products, during the study period. Subjects are allowed to style their hair as they normally would with usual products that are not for thickening/volumizing.

8. Willing to arrive at the testing center for scheduled study visits having not used any hair styling

products on the day of each visit

9. Willing to forego all swimming during study period

Exclusion Criteria

1. Subjects currently using any hair thickening or hair growth treatments (ex. Rogaine)




4. Subjects participating in any other clinical studies



compromise study outcomes. Typical uncontrolled chronic or serious diseases and conditions which





Page 2 of 6

would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal

impairment, mental illness, drug/alcohol addiction.

6. Subjects who are unreliable or unlikely to be available for the duration of the study

7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients,

toiletries, sunscreens, etc.



Subjects who become pregnant during the study must inform the Principal Investigator immediately

10. Individuals unable to communicate or cooperate with the Principal Investigator due to language

problems, poor mental development, or impaired cerebral function

11. Employees of IRSI or other testing firms/ laboratories, cosmetic or raw goods manufacturers or

suppliers

3.0 PROCEDURES

You are being asked to voluntarily participate in a six (6) week study. The study involves two (2) visits to the test office, including today’s visit. Each visit will last approximately thirty (30) minutes. The study will include approximately thirty (30) test subjects. At today’s visit you will be asked to read and sign this informed consent prior to receiving any study instructions. You will also be asked to complete a brief medical/personal history. Qualification for study participation will be evaluated by an IRSI technician using information collected from your medical history as well as an inclusion/ exclusion checklist. If you qualify at this visit, you will continue onto the Baseline Portion of the study, which will also take place today. At the Baseline Portion of today’s visit, you will be required to arrive at the testing center having washed your hair within the past 24 hours and allowed it to dry completely, styled in usual manner with simple hair down style with no styling products. You will undergo visual and instrumental assessments. After all baseline assessments are completed, you will be provided with the study product regimen, as well as verbal and written instructions and application diary. Upon completion of all Baseline evaluations you will be dismissed from the Baseline visit and reminded of your Week 6 Visit. At the Week 6 Visit, you will be required to arrive at the testing center having washed your hair within the past 24 hours and allowed it to dry completely, styled in usual manner with simple hair down style with no styling products. You will then be questioned for any changes in your medical history as well as compliance to the study instructions. You will then undergo visual and instrumental assessments and complete a questionnaire regarding your opinion of the test regimen. You will return products and then you will receive your stipend for study participation and be dismissed from the study.

3.1 PRODUCT APPLICATION

All subjects will receive treatment in this clinical study. A hair care regimen (shampoo, conditioner, scalp solution, brush and vitamins) is being evaluated on its ability to improve hair and scalp condition





Page 3 of 6

and appearance after repeated use. At today’s visit you will be provided with the test products to use at home throughout the six (6) week treatment period, per sponsor instructions. 3.2 EXPERT GRADER ASSESSMENTS

At each visit you will have your hair visually evaluated by a trained expert grader or technician. Visual assessments will include how your hair looks and feels.

3.3 INSTRUMENTAL EVALUATION

At each visit you will have your scalp evaluated with non-invasive bio-instrumentation. Four instruments will be used in this study, the pH Meter, the Corneometer, the Vapo Meter and the SIAScope.

3.4 SUBJECTIVE QUESTIONNAIRE

You will be asked to complete a questionnaire regarding your level of agreement with statements about the products and product performance following 6 weeks of use.

4.0 COMPENSATION

You will receive $60.00 for completing the study as directed. If you are not qualified for this study you will not be compensated. If you are present and qualified, but not enrolled due to overbooking, you will be paid $20.00. Please note that it is the policy of IRSI to overbook all studies due to high rates of cancellations and no-shows. Completing the study paperwork does not guarantee enrollment into the study, even if you meet the entry criteria and qualify. If you are discontinued from the study you may be paid on the basis of the visits you have completed.

If you withdraw from this study for personal reasons unrelated to the test materials, you will not be compensated. If you are disqualified for refusal to obey rules, follow instructions or attend all visits as scheduled, you will not be compensated.

This is a voluntary study and you may withdraw at any time without obligation or prejudice. The sponsor and/or investigative staff may remove you from this study at any time for any reason without loss of benefits, except as stated above.

Payment will be by Clincard within approximately 24 hours of the final study visit if not available the day of the final visit.

5.0 POTENTIAL BENEFIT

You may notice an improvement in your hair/scalp condition during the eight (8) week treatment period. However, the amount is unknown and will vary among participants.





Page 4 of 6

6.0 POTENTIAL RISKS

The test products are for you ONLY to use. The products are for external use only.

It is possible to develop irritation on your head/scalp/hair. If a study area becomes irritated, you should contact IRSI immediately. It is possible to develop a reaction to products such as those being tested and the cleanser being used throughout the study period including but not limited to stinging, redness, dryness, flaking, burning, rash and itching. Some risks are unknown and you will be advised if more information becomes available.

If you have a history of reactions to shampoos/conditioners/hair products you must not participate in this study. If you have no history of sensitivity the likelihood of a reaction is minimal and similar to that if you purchased and used comparable products on your own.

Reactions, if any, usually occur at or around the test area (head, hair and scalp) but are not limited to these areas. Reactions may persist in some individuals. In the event of a reaction you should immediately contact:

Anna, Study Coordinator at (914) 937-6500, Ext. 126

In the event of a medical emergency, you should seek medical attention first and then contact IRSI.

If you experience an injury as a direct result of administration of the test material, the study sponsor agrees to pay medical expenses necessary to treat such injury: (1) To the extent you are not otherwise reimbursed by your own medical insurance, (2) provided you have followed the directions of the investigator before and after the injury occurred. Additional financial compensation will not be provided. Medical follow-up will be provided until the investigator or study coordinator determines you have recovered.

If you withdraw due to personal reasons related to product usage other than a response judged by IRSI staff to be a reaction to test product or instructions, you may not be paid. If, in the judgment of the investigative staff, it is best to discontinue your participation for reasons such as a documented medical condition not related to study materials, product failure or study termination, you will be paid for that portion of the study you have completed (pro rata), according to the number of scheduled visits made to the office. If your participation in the study is stopped due to an adverse reaction related to use of the test material or test instructions, you will be paid the full stipend amount.

If you are pregnant or planning on becoming pregnant or at significant risk of becoming pregnant during this test, you should not enroll in the test. Although no side effects to pregnancy are expected from the test materials the risks are unknown. If you become pregnant during the test you will immediately stop product use and notify IRSI.

For safety reasons, even if you drop from this study you may be asked to make follow-up visits to the study facility or to a physician. In the event of a reaction this is especially important for your safety and so that accurate information can be obtained.





Page 5 of 6

7.0 CONFIDENTIALITY OF RECORDS

Reports prepared by IRSI use statistical information only and at no time will your name be used in these reports. The sponsor, the FDA and others in certain legal action, may inspect the records of this study which will include your name, medical records and, if applicable, personal information relating to your participation.

By signing this consent form you authorize the release of your medical records, only for treatment of illnesses and injuries related to this study to IRSI, and the study sponsor. IRSI will not release any information in your medical records except as stated in this consent.

8.0 USE OF PERSONAL INFORMATION (HIPAA) AUTHORIZATION

Your participation in this study will involve disclosing some of your personal data and medical information (allergies, medications, illnesses, conditions and demographics {age, sex, race, and occupation}) as well as name, address, email address, Social Security Number, and phone number to IRSI.

The Study Coordinator, Investigator or authorized staff member may ask you for this information. By signing this consent form you authorize the release of your medical records (for treatments, illnesses and injuries as a direct result of test material use) to IRSI.

The same staff and management that write IRSI’s reports will review or use the medical information you report. At no time will your name, address, phone number, email address or social security number be published in a report. The study Sponsor, and the FDA may be granted access to your personal information regarding this study. IRSI will use the medical information you provide in order to conduct this study.

Additionally, IRSI will use the medical information in its database so that IRSI may be able to contact you to participate in future studies. Therefore, your authorization to IRSI to use the medical information and data you provide has no end date.

You have the right to revoke this authorization so long as IRSI has not already relied on or used the information you provided for this study. At your written request, IRSI will not contact you for future studies. Only employees who have signed a confidentiality agreement are permitted to access the database. IRSI does not sell the identifying information in the database. Even if you take back your consent to participate in this study the Use of Personal Information authorization will remain in effect.

Your signature below indicates you have read the above privacy statement.

Signature:

Date:




Page 6 of 6

9.0 CONSENT OF SUBJECT

I have read and fully understand this consent and what is required of me during this study. I understand the risks, benefits and procedures and that I am free to ask questions at any time. I have no questions at this time. Additional information regarding the test material may become available to me during this study. If additional information becomes available or the study procedures are changed and this affects my well-being a new consent form will be provided to me. By signing this consent I authorize the release of my medical records in the event of an illness, injury or reaction related to this study. The investigator or a member of the staff will be available at (914) 937-6500 to answer my questions. I have read this consent and I freely and voluntarily agree to participate in this study as described to me. By signing this form I forfeit none of my legal rights.

Signature: Date:

Print Name:

Last: First: M.I:

Street Address: City: State: Zip:

Home Phone: Cell Phone: Work Phone:

E-Mail Address:

Social Security Number:

DO NOT WRITE BELOW THIS LINE

*************************************************************************************

Witness Signature: Person Administering Consent (IRSI Personnel)

Signature: Date:

Print Name:

Last: First:


CONFIDENTIAL APPENDIX V

Appendix V

Laser Hair Brush Instructions

Shantique Laser Hair Brush .$175.00 $175.00

Shantique Massage Hair Brush . Kit Includes 2 Brushes:

Brush A: Adopts low-level cool Laser, together with far Infrared and impulse. It has been demonstrated to

increase the blood flow and circulation in the scalp, a healthy hair follicle.

Laser: Laser light therapy stimulates the blood flow to the scalp which brings oxygen and nutrients to the scalp

area. The increased blood flow creates a healthy environment for the hair to grow. Hair will appear thicker,

fuller and healthier.

Infrared Therapy: Infrared waves activate cells and promotes metabolism, removing dead cells and

reproducing new ones.

Impulse: Impulse can have incomparable effect in treatment of hair-loss; it generates micro-electricity to

activate cells and hair follicles. The brush is designed to align the laser beam ensuring no hair cells are missed

during treatment.

Brush B: can be combined with the Spare My Hair Scalp Hair Solution. which on can be effused from the

entrance, and come out from several pipes. In this way, it can take the Spare My Hair Scalp Hair Solution.

deeply into the hair root, and its massaging vibration probe can better promote the absorb ability by hair

follicle. Compared with smearing the Spare My Hair Scalp Hair Solution. with hand, this technique allows

Bush B to achieve a better effect

Hai Shantique Laser Hair Brush . Instructions

You will receive Shantique Laser Hair Brush . Kit It Includes 2 Brushes, Spare

My Hair Scalp Hair Solution and a Small Funnel.

Instructions for use:

Plug the laser Brush A to charge.

Using the small funnel enclosed in your package, introduce Spare My Hair Scalp Hair Solution. to the

opening on top of brush B .Close the top and secure it tightly.

Use brush B on dry or wet hair, starting from the front of the scalp moving half an inch backward

every four seconds –Use it on the entire scalp for a period that doesn’t exceed 10 to 15 minutes per

session.

Spare My Hair Scalp Hair Solution. which can be effused from the entrance, and come out from

several pipe. In this way, it can take the Spare My Hair Scalp Hair Solution. deeply into the hair root,

and its massaging vibration probe can better promote the absorbability by hair follicle. Compared with

smearing the Spare My Hair Scalp Hair Solution. with hand, this technique allows Brush B to achieve

a better effect.

Now use laser Brush A immediately after Brush B starting from the front of the scalp moving half an

inch every four seconds –Use it on the entire scalp for a period that doesn’t exceed 10 to 15 minutes

per sessions .It is not recommended to use it any longer or more frequent than advised.

Brush A: Adopts low-level cool Laser, together with far Infrared and impulse. It has been

demonstrated to increase the blood flow and circulation in the scalp, promoting a healthy hair follicle.

Laser: Laser light therapy stimulates the blood flow to the scalp which brings oxygen and nutrients to

the scalp area. The increased blood flow creates a healthy environment for the hair to grow. Hair will

appear thicker, fuller and healthier.

Infrared Therapy: Infrared waves activate cells and promotes metabolism, removing dead cells and

reproducing new ones.

Impulse: Impulse can have incomparable effect in treatment of hair-loss; it generates micro-electricity

to activate cells and hair follicles. The brush is designed to align the laser beam ensuring no hair cells

are missed during treatment.

REPEAT THREE TIMES A WEEK FOR 26 WEEKS FOR TREATMENT.THEN ONCE A WEEK

AFTERWARDS FOR MAINTENANCE.

Battery Charging: In charging, the red light will be on when the comb is in charging state. The green

light will turn on when the comb is not in suitable charging position, cannot be charged properly. When

the charging is enough and over, green light will turn on. Tips: The product can be used as a daily

appliance for an indefinite time period. Avoid using with other chemosynthesis hair-growth products that

contained hormones.

DO NOT use for other purposes.

DO NOT use it together with other electrical appliance.

DO NOT use for other parts of the body. Head use only.

Make sure your hands are dry when you plug or unplug this unit.

DO NOT disassemble. No user serviceable parts.

Security Warnings: The following people should not use the laser comb massager:

If the person has electric appliances on their body, such as pace makers

If the person is receiving electrotherapy.


CONFIDENTIAL Appendix II

Appendix II

Statistical Report and Data Listing

Page 1 of 46

08/23/17

INTERNATIONAL RESEARCH SERVICES, INC.

HAIR CARE REGIMEN STUDY #4141SH0617

MEDICAL HISTORY

E R F B F S E L O

INI- S T A A O I K Y E C

SUBJ TIAL HGT WGT AGE E H C C D T I E N C SPECIFY

---- ---- ---- --- --- X N E E Y Z N S S U -------------------------

01 JJG 68.0 180 51 M N W C N 3 N N N E INSURANCE MGR

02 JMM 61.0 138 48 F N W C N 2 N N N E CLINICAL SERVICES

03 S-A 62.0 112 37 F N A D D 3 Y N Y E SR. RECRUITER

04 SJP 74.0 270 37 M N W O N 3 Y Y N E ACCOUNTANT

05 R-S 63.0 162 60 F N W C N 3 Y N N E SEAMSTRESS

06 LNS 66.0 210 59 M N W N N 3 N N N R

07 JAD 69.0 196 62 M N W N N 2 Y Y N E CONSULTANT

08 DJA 73.0 180 65 M N W N D 3 N N N R

09 DEM 70.0 153 65 M N W C N 3 Y Y N R

10 PRM 63.0 120 63 F N W N N 3 N N N E GENERAL MGR

11 C-H 72.0 210 45 M N W C N 3 Y N N E TEACHER

13 P-A 63.0 135 60 F N A C D 4 N N N R

14 AML 62.0 135 56 F N W N N 2 N N N E OFFICE MGR

15 M-D 65.0 126 58 F N W C D 4 N N Y E T.A.

16 GCH 72.0 195 58 M N A N N 4 N N N E CONSULTANT

17 RVM 74.0 220 59 M N W N N 3 N N N E SALES

18 S-S 64.0 189 44 F H A C N 4 N N N E MANAGER

19 FDP 67.0 130 56 F N W C N 3 N N Y E TEACHER

20 J-P 70.0 230 58 M N W N N 3 N N N R

21 D-H 61.5 170 58 F N W C N 2 N N N E RECEPTIONIST

22 MJB 65.0 150 57 F N W N N 4 N N Y E TEACHER

23 J-D 64.0 183 61 F N W N N 4 N N N E SELF

24 R-R 62.0 122 62 F N W C N 2 N N N R

Page 2 of 46

08/23/17



MEDICAL HISTORY

E R F B F S E L O

INI- S T A A O I K Y E C

SUBJ TIAL HGT WGT AGE E H C C D T I E N C SPECIFY

---- ---- ---- --- --- X N E E Y Z N S S U -------------------------

25 DIK 73.0 266 63 M N W N N 3 N N N R

26 A-T 67.0 150 44 M H O N 4 N N N U

27 S-M 66.0 128 61 F N W N O 4 N Y N H

28 AJN 62.0 200 55 F N W D N 3 Y Y Y E SCHOOL AIDE

31 NMA 64.0 200 40 F N W C D 3 N N N H

32 JJG 69.0 265 64 M N W N N 3 Y N N E P/T DELIVERY

33 M-C 68.0 210 62 M N W N N 3 N N N R

Page 3 of 46

08/23/17



VISUALS

EVAL SOFT SCALP

TIME SHINE VOLUME NESS HEALTH

------ ----- ------ ---- ------

** SUBJECT = 01

BASE 2.0 2.5 3.0 4.0

WK-6 3.5 3.0 3.5 3.5

** SUBJECT = 02

BASE 3.0 2.0 3.0 2.5

WK-6 3.5 3.0 3.0 4.0

** SUBJECT = 03

BASE 1.5 2.5 1.5 3.0

WK-6 2.5 3.0 2.5 3.0

** SUBJECT = 04

BASE 2.0 1.0 1.0 3.0

WK-6 2.5 2.5 3.5 3.5

** SUBJECT = 05

BASE 2.0 2.5 2.5 3.0

WK-6 2.5 2.5 2.5 3.0

** SUBJECT = 06

BASE 2.0 1.0 2.5 2.5

WK-6 3.0 1.5 3.0 3.0

** SUBJECT = 07

BASE 1.5 2.5 2.5 2.0

WK-6 2.5 3.0 3.0 3.0

** SUBJECT = 08

BASE 2.0 2.0 2.0 2.5

WK-6 2.5 1.5 3.0 3.5

** SUBJECT = 09

BASE 1.0 2.0 2.0 2.5

WK-6 2.5 2.0 2.0 2.5

** SUBJECT = 10

BASE 2.0 2.0 2.0 3.0

WK-6 3.0 3.0 2.0 3.0

** SUBJECT = 11

BASE 2.0 2.5 2.0 2.5

WK-6 3.0 1.5 3.0 2.5

Page 4 of 46

08/23/17



VISUALS

EVAL SOFT SCALP


------ ----- ------ ---- ------

** SUBJECT = 13

BASE 1.0 2.0 2.0 3.0

WK-6 2.0 2.5 3.0 3.0

** SUBJECT = 14

BASE 2.0 3.0 2.0 3.0

WK-6 2.5 2.5 2.5 3.0

** SUBJECT = 15

BASE 2.0 2.0 2.0 3.0

WK-6 2.5 2.5 3.0 3.0

** SUBJECT = 16

BASE 2.0 2.0 2.0 2.0

WK-6 3.0 2.0 3.0 3.0

** SUBJECT = 17

BASE 1.5 2.0 2.0 2.5

WK-6 2.0 2.5 2.5 2.5

** SUBJECT = 18

BASE 2.5 2.5 2.5 3.0

WK-6 3.0 3.0 2.5 2.5

** SUBJECT = 19

BASE 2.5 3.0 2.0 3.0

WK-6 2.5 3.0 2.5 2.5

** SUBJECT = 20

BASE 2.0 2.0 2.0 2.5

WK-6 2.5 2.0 3.0 2.5

** SUBJECT = 21

BASE 2.0 2.5 2.0 2.0

WK-6 3.0 3.0 2.5 3.0

** SUBJECT = 22

BASE 2.0 2.0 2.0 3.0

WK-6 2.5 3.0 2.5 3.0

** SUBJECT = 23

BASE 2.0 2.0 2.0 3.0

WK-6 2.5 2.5 2.0 2.5

** SUBJECT = 24

BASE 2.0 2.0 2.0 2.0

WK-6 3.0 2.5 3.0 3.0

Page 5 of 46

08/23/17



VISUALS

EVAL SOFT SCALP


------ ----- ------ ---- ------

** SUBJECT = 25

BASE 2.0 1.0 2.0 2.5

WK-6 2.0 2.0 3.0 3.0

** SUBJECT = 26

BASE 2.5 2.5 2.5 3.0

WK-6 3.0 3.0 3.0 3.0

** SUBJECT = 27

BASE 2.0 3.0 2.0 3.0

WK-6 2.5 3.0 2.5 3.5

** SUBJECT = 28

BASE 2.0 2.0 2.0 2.0

WK-6 3.0 3.0 3.0 3.0

** SUBJECT = 31

BASE 2.0 2.0 2.0 2.0

WK-6 2.5 2.5 3.0 3.0

** SUBJECT = 32

BASE 2.0 2.5 2.0 2.5

WK-6 2.5 1.5 2.5 2.5

** SUBJECT = 33

BASE 1.5 1.5 1.5 3.0

WK-6 2.0 2.0 2.0 3.0

Page 6 of 46

08/23/17



INSTRUMENTS

HEMO HEMO HEMO HEMO

EVAL CORN CORN CORN AVG. MEAN SD MEAN SD HEMO

TIME PH -1- -2- -3- CORN -1- -1- -2- -2- AVG.

------ ---- ---- ---- ---- ---- ------ ------ ------ ------ ------

** SUBJECT = 01

BASE 5.34 34.1 32.6 33.3 33.3 221.65 31.25 217.66 26.77 219.66

WK-6 4.13 39.2 45.7 43.2 42.7 183.59 42.51 186.77 35.62 185.18

** SUBJECT = 02

BASE 5.47 24.0 24.7 25.4 24.7 209.58 147.61 271.71 210.54 240.64

WK-6 5.76 4.6 4.1 3.2 4.0 203.48 241.98 196.48 202.48 199.98

** SUBJECT = 03

BASE 6.27 9.3 10.5 10.2 10.0 205.70 163.12 220.10 179.79 212.90

WK-6 5.88 6.6 6.7 10.2 7.8 274.84 287.76 275.58 290.87 275.21

** SUBJECT = 04

BASE 5.48 22.3 22.9 22.5 22.6 225.46 70.29 226.54 25.16 226.00

WK-6 4.66 39.0 39.7 40.6 39.8 202.76 15.67 195.48 24.45 199.12

** SUBJECT = 05

BASE 5.55 4.7 4.9 5.1 4.9 217.22 138.86 219.22 116.63 218.22

WK-6 6.11 5.2 3.6 4.0 4.3 153.92 64.39 168.14 99.29 161.03

** SUBJECT = 06

BASE 5.24 19.7 19.3 20.0 19.7 227.36 31.72 223.19 32.51 225.28

WK-6 5.18 15.6 11.4 13.9 13.6 204.48 19.88 203.29 36.44 203.88

** SUBJECT = 07

BASE 5.36 51.7 54.5 61.5 55.9 228.24 32.63 209.06 20.80 218.65

WK-6 4.61 51.1 44.8 45.6 47.2 200.31 33.12 182.58 20.22 191.44

** SUBJECT = 08

BASE 6.42 9.9 13.2 13.3 12.1 231.38 27.54 255.95 48.28 243.66

WK-6 5.75 14.2 14.9 14.1 14.4 211.89 61.15 209.73 34.10 210.81

** SUBJECT = 09

BASE 5.67 10.4 10.3 12.9 11.2 215.97 41.89 217.48 39.26 216.72

WK-6 5.17 28.9 33.6 24.2 28.9 191.81 24.32 200.12 47.46 195.97

** SUBJECT = 10

BASE 6.52 4.2 4.9 5.9 5.0 148.20 65.58 162.93 74.70 155.56

WK-6 5.96 8.6 6.6 11.7 9.0 195.96 102.65 160.38 52.47 178.17

** SUBJECT = 11

BASE 6.43 3.5 4.0 4.4 4.0 209.76 59.01 256.43 112.68 233.09

WK-6 5.70 3.6 5.7 5.4 4.9 193.59 31.17 223.08 90.89 208.34

** SUBJECT = 13

BASE 5.85 28.3 27.8 31.4 29.2 234.07 30.05 223.88 50.57 228.97

WK-6 4.60 19.7 10.7 13.1 14.5 187.61 43.73 195.22 78.43 191.42

Page 7 of 46

08/23/17



INSTRUMENTS

HEMO HEMO HEMO HEMO


TIME PH -1- -2- -3- CORN -1- -1- -2- -2- AVG.

------ ---- ---- ---- ---- ---- ------ ------ ------ ------ ------

** SUBJECT = 14

BASE 6.14 10.5 9.5 13.5 11.2 239.59 162.93 200.38 103.32 219.99

WK-6 6.23 8.2 8.8 12.0 9.7 156.53 48.13 190.74 104.31 173.63

** SUBJECT = 15

BASE 5.95 46.7 48.0 53.2 49.3 237.68 59.30 244.19 42.14 240.94

WK-6 6.06 4.1 4.8 5.6 4.8 159.74 44.24 189.36 71.48 174.55

** SUBJECT = 16

BASE 6.16 61.4 63.8 64.5 63.2 217.66 19.37 213.99 31.72 215.82

WK-6 5.19 59.1 58.9 60.9 59.6 211.45 24.89 205.46 28.93 208.45

** SUBJECT = 17

BASE 6.44 5.8 6.3 6.7 6.3 300.85 210.37 217.83 87.71 259.34

WK-6 5.38 11.8 12.6 14.0 12.8 197.04 138.27 226.68 166.74 211.86

** SUBJECT = 18

BASE 6.11 5.8 6.4 8.6 6.9

WK-6 5.16 36.1 39.1 37.8 37.7

** SUBJECT = 19

BASE 5.73 38.8 45.7 49.7 44.7 210.67 45.09 212.87 71.25 211.77

WK-6 5.45 20.6 26.2 28.3 25.0 154.15 26.44 149.76 47.90 151.95

** SUBJECT = 20

BASE 5.53 64.4 67.4 68.4 66.7 225.64 28.51 227.62 20.81 226.63

WK-6 4.24 67.1 58.5 61.8 62.5 224.38 26.23 218.19 42.99 221.28

** SUBJECT = 21

BASE 5.63 27.0 29.4 31.4 29.3 216.38 65.50 221.01 38.93 218.69

WK-6 5.05 24.5 24.5 26.7 25.2 214.21 90.49 177.34 44.42 195.78

** SUBJECT = 22

BASE 5.62 16.3 18.9 21.1 18.8 259.75 119.50 209.56 47.01 234.66

WK-6 5.24 16.8 18.0 12.9 15.9 170.73 101.48 185.37 58.83 178.05

** SUBJECT = 23

BASE 5.22 20.2 22.3 33.6 25.4 190.27 78.99 214.23 98.42 202.25

WK-6 5.25 25.7 27.9 22.4 25.3 143.31 57.86 162.78 29.60 153.05

** SUBJECT = 24

BASE 5.49 23.4 17.3 20.7 20.5 187.68 36.93 202.26 43.49 194.97

WK-6 5.95 45.6 51.1 45.0 47.2 187.77 101.01 154.76 26.72 171.26

** SUBJECT = 25

BASE 4.80 52.4 58.6 59.6 56.9 232.37 113.97 228.39 81.38 230.38

WK-6 5.35 20.4 13.5 17.2 17.0 179.42 109.35 261.39 190.61 220.40

Page 8 of 46

08/23/17



INSTRUMENTS

HEMO HEMO HEMO HEMO


TIME PH -1- -2- -3- CORN -1- -1- -2- -2- AVG.

------ ---- ---- ---- ---- ---- ------ ------ ------ ------ ------

** SUBJECT = 26

BASE 6.03 9.1 10.2 10.7 10.0 224.24 37.10 213.12 32.08 218.68

WK-6 4.45 59.6 55.9 45.3 53.6 204.74 60.60 191.38 105.75 198.06

** SUBJECT = 27

BASE 6.04 16.2 17.0 19.1 17.4 242.38 62.47 258.16 108.51 250.27

WK-6 4.78 6.1 8.1 2.9 5.7 192.31 50.39 195.36 62.37 193.84

** SUBJECT = 28

BASE 5.46 6.5 8.0 8.4 7.6 179.05 13.88 192.65 35.08 185.85

WK-6 4.34 5.3 3.2 3.6 4.0 159.41 45.44 146.97 58.48 153.19

** SUBJECT = 31

BASE 5.56 4.7 4.7 5.4 4.9 203.44 79.21 193.13 99.23 198.28

WK-6 5.36 7.6 4.8 4.2 5.5 129.80 60.80 133.95 142.92 131.88

** SUBJECT = 32

BASE 5.45 44.2 46.9 47.7 46.3 239.47 45.51 268.97 46.78 254.22

WK-6 5.09 28.0 31.8 36.3 32.0 224.84 38.50 236.32 46.16 230.58

** SUBJECT = 33

BASE 4.64 37.6 44.7 48.7 43.7 209.78 27.25 206.59 24.55 208.19

WK-6 4.30 34.2 43.1 41.0 39.4 215.05 27.46 214.08 39.05 214.56

Page 9 of 46

08/24/17



VAPOMETER

W VAPO- VAPO- AVG.

E METER METER VAPO-

E -1- -2- METER

K ----- ----- -----

** SUBJECT = 1

0 30.9 26.9 28.9

6 19.1 16.5 17.8

** SUBJECT = 2

0 17.5 27.0 22.3

6 17.6 15.5 16.6

** SUBJECT = 3

0 19.7 15.9 17.8

6 14.6 11.2 12.9

** SUBJECT = 4

0 25.9 28.3 27.1

6 21.0 16.3 18.7

** SUBJECT = 5

0 26.8 18.7 22.8

6 14.8 13.5 14.2

** SUBJECT = 6

0 12.3 12.8 12.6

6 9.4 12.0 10.7

** SUBJECT = 7

0 50.7 40.6 45.7

6 11.8 11.8 11.8

** SUBJECT = 8

0 15.5 13.5 14.5

6 13.2 11.2 12.2

** SUBJECT = 9

0 14.6 17.3 16.0

6 12.8 12.4 12.6

** SUBJECT = 10

0 13.6 15.5 14.6

6 32.3 22.6 27.5

** SUBJECT = 11

0 27.7 21.1 24.4

6 12.5 15.3 13.9

** SUBJECT = 13

0 9.8 9.5 9.7

6 8.5 9.2 8.9

Page 10 of 46

08/24/17



VAPOMETER

W VAPO- VAPO- AVG.

E METER METER VAPO-

E -1- -2- METER

K ----- ----- -----

** SUBJECT = 14

0 9.5 9.9 9.7

6 8.6 9.0 8.8

** SUBJECT = 15

0 34.2 35.3 34.8

6 22.8 19.6 21.2

** SUBJECT = 16

0 14.2 15.2 14.7

6 12.3 13.7 13.0

** SUBJECT = 17

0 18.2 18.3 18.3

6 13.3 13.0 13.2

** SUBJECT = 18

0 17.0 18.5 17.8

6 11.0 11.5 11.3

** SUBJECT = 19

0 75.9 36.9 56.4

6 11.5 10.8 11.2

** SUBJECT = 20

0 17.6 15.3 16.5

6 12.0 12.4 12.2

** SUBJECT = 21

0 16.7 16.0 16.4

6 13.8 13.8 13.8

** SUBJECT = 22

0 11.7 13.0 12.4

6 12.3 11.0 11.7

** SUBJECT = 23

0 26.9 35.9 31.4

6 8.6 7.8 8.2

** SUBJECT = 24

0 10.1 10.9 10.5

6 10.1 10.4 10.3

Page 11 of 46

08/24/17



VAPOMETER

W VAPO- VAPO- AVG.

E METER METER VAPO-

E -1- -2- METER

K ----- ----- -----

** SUBJECT = 25

0 43.7 40.6 42.2

6 14.3 12.9 13.6

** SUBJECT = 26

0 13.5 15.8 14.7

6 11.6 12.1 11.9

** SUBJECT = 27

0 29.1 15.1 22.1

6 8.7 7.5 8.1

** SUBJECT = 28

0 30.5 34.1 32.3

6 13.7 15.9 14.8

** SUBJECT = 31

0 13.7 15.1 14.4

6 10.9 10.6 10.8

** SUBJECT = 32

0 28.4 27.6 28.0

6 18.2 18.5 18.4

** SUBJECT = 33

0 17.2 14.1 15.7

6 9.1 9.0 9.1

Page 12 of 46

08/23/17


HAIR CARE REGIMEN STUDY #4141SH0617'

QUESTIONNAIRE PART 1.

SUBJ Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9

---- -- -- -- -- -- -- -- -- --

01 2 2 2 2 3 3 2 3 3

02 3 2 1 2 3 3 3 3 3

03 2 2 1 1 2 4 2 2 2

04 1 2 3 2 3 4 3 4 4

05 2 2 1 2 2 2 1 2 1

06 1 2 2 2 3 1 1 2 2

07 4 3 4 4 3 4 4 4 4

08 3 2 4 2 3 2 2 3 4

09 3 2 3 1 3 3 3 3 3

10 4 4 4 4 3 3 2 3 3

11 3 4 4 2 3 4 4 3 3

13 2 2 2 2 3 2 2 2 2

14 3 2 1 2 1 1 1 1 1

15 3 2 4 2 3 2 4 3 4

16 2 2 2 2 3 2 2 1 1

17 2 1 1 2 3 1 1 1 1

18 3 3 2 2 3 2 2 2 2

19 2 3 1 1 3 3 2 2 2

20 2 2 2 2 3 3 3 2 2

21 1 2 1 1 1 2 3 3 2

22 3 3 3 3 3 4 4 3 4

23 3 3 3 2 3 2 2 3 3

24 2 2 1 2 1 2 2 1 2

Page 13 of 46

08/23/17


HAIR CARE REGIMEN STUDY #4141SH0617'


SUBJ Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9

---- -- -- -- -- -- -- -- -- --

25 1 2 1 1 1 2 2 1 1

26 1 2 2 1 1 3 3 3 2

27 3 4 2 4 2 1 1 3 3

28 3 2 2 2 3 2 3 3 3

31 2 3 2 4 3 2 2 5 4

32 3 4 4 3 3 4 4 3 4

33 3 4 4 3 3 4 2 4 4

Page 14 of 46

08/23/17




LIKE DISLIKE

------------------------------ ------------------------------

** SUBJECT = 01

THE SCENT THE SHAMPOO & CONDITIONER VERY

EXTREMELY THICK AND DIFFICULT

TO USE.

** SUBJECT = 02

MADE HAIR SHINY AND FULL. THE CONSISTENCY OF THE SHAMPOO

ALTHOUGH IT DID CLEAN MY HAIR.

** SUBJECT = 03

MADE MY HAIR LOOK THICKER AND BRUSH B LEAKED SOLUTION AT

VOLUMINOUS/LUSTROUS. REDUCED CERTAIN ANGLES. SHAMPOO TOO

HAIR LOSS WHILE BRUSHING. THICK, DIFFICULT TO SPREAD.

DID NOT LATHER WELL. HAD TO

USE A LARGER QUANTITY. DID NOT

LIKE CONDITIONER FRAGRANCE...

TOO THICK.

** SUBJECT = 04

MADE MY SCALP FEEL MORE IT WAS A PROJECT AND TOO MUCH

HYDRATED AND HAIR SOFTER. TO KEEP UP WITH.

** SUBJECT = 05

WOULD LIKE TO PURCHASE THESE

PRODUCTS.

** SUBJECT = 06

EASY TO USE. SMELLS GOOD. NOTHING, BRUSH HAD HARD

BRISTLES.

** SUBJECT = 07

NONE TOO MUCH PERFUME.

** SUBJECT = 08

SHAMPOO & CONDITIONER HAD EXCESSIVE TIME FOR

PLENTY OF VOLUME AND PLEASANT NON-NOTICEABLE RESULTS.

SCENT. PRODUCED PLENTY OF

SUDS. PRODUCT WENT A LONG WAY.

VITAMINS ARE COMMON, FOUND IN

A MULTIPLE VITAMIN FOR OVERALL

HEALTH.

** SUBJECT = 09

MADE HAIR SOFTER NOTHING

** SUBJECT = 10

SMELL I FELT MY HAIR WAS DRYER.

Page 15 of 46

08/23/17




LIKE DISLIKE

------------------------------ ------------------------------

** SUBJECT = 11

THE COMBS - LASER FELT LIKE IT PILLS 3X PER DAY. WOULD BE

WAS WORKING. BETTER IF IT WAS 1 PILL.

** SUBJECT = 13

IT WAS VERY USEFUL AND SHAMPOO WAS TOO THICK. HARD TO

EFFECTIVE. DISPENSE. WAS TOO MUCH TIME TO

USE IN THE BATHROOM.

** SUBJECT = 14

HOW THE CONDITIONER LEFT MY HOW THE PRODUCTS (SHAMPOO &

HAIR FEELING SOFT AND SMOOTH. CONDITIONER) SMELLED. HOW THE

SPRAY MADE MY HAIR FEEL.

** SUBJECT = 15

THE SMELL. THE SCALP SPRAY. THE SHAMPOO MADE MY HAIR

FRIZZY. THE SHAMPOO DIDN'T

LATHER UP.

** SUBJECT = 16

THE ... & HEALTH REASONS FOR REQUIRES

THE "LIGHTED" "LASER" COMB. REGIMENTATION/ROUTINE. TAKES

TIME, ESPECIALLY THE 10-MINUTE

SESSION EACH OF THE VIBRATING

& INFRARED COMB.

** SUBJECT = 17

SAW MORE OF A FULLNESS ON MY PRODUCTS SEEMED TO THICK AND

HEAD, EASY TO APPLY, THIN HAIR TOOK A LITTLE MORE EFFORT TO

SEEMED TO BE A LITTLE THICKER. APPLY.

OVERALL GREAT EXPERIENCE.

** SUBJECT = 18

THE FRAGRANCE IN THE SHAMPOO, SOLUTION RAN DOWN FOREHEAD.

CONDITIONER AND SOLUTION.

LOVED THE LASER TO STIMULATE

SCALP. NOTICED LESS HAIR IN

THE DRAIN!

** SUBJECT = 19

IT GAVE MY HAIR VOLUME AND THE SMELL. SHAMPOO WAS

SOFTNESS. SOMEWHAT THICK TO LATHER.

** SUBJECT = 20

HELPED MY HAIR HEALTH. CAN'T SHAMPOO DID NOT LATHER-UP

DETERMINE WHAT THEY DID FOR MY MUCH. BOTH PRODUCTS WERE

SCALP. HAD A NICE SCENT. THICK.

Page 16 of 46

08/23/17




LIKE DISLIKE

------------------------------ ------------------------------

** SUBJECT = 21

GOOD CONDITIONING. HAIR WAS SMELL OF SCALP CONDITIONER.

FULLER. SMELLED LIKE "FANTASTIC"

CLEANER. TOO, TOO THICK. HARD

TO GET OUT OF BOTTLES. SHAMPOO

DID NOT LATHER. DIDN'T USE

LONG ENOUGH TO SEE IF IT

IMPROVES HAIR GROWTH.

** SUBJECT = 22

I WAS HOPING TO SEE A DRAMATIC

OR SLIGHT IMPROVEMENT. SPRAY

LEFT HAIR GREASY. SHAMPOO HARD

TO LATHER. TIME CONSUMING.

** SUBJECT = 23

THE BRUSHES. SOMETHING I WOULD SCALP SOLUTION WAS STICKY.

LIKE TO HAVE. SHAMPOO DID NOT LATHER ENOUGH.

CONDITIONER MADE MY HAIR TOO

SOFT AND IT LOST VOLUME

BECAUSE OF THAT.

** SUBJECT = 24

CONDITIONER. A LOT OF WORK.

** SUBJECT = 25

THE OVERALL EFFECTIVENESS IN THE SHAMPOO AND CONDITIONER

THE IMPROVEMENT OF THE HEALTH BOTTLES SHOULD ALLOW FOR

AND GROWTH OF MY HAIR, EASIER SQUEEZING.

** SUBJECT = 26

IT MADE A DIFFERENCE IN MY NONE

SCALP HEALTH. NOTICED MY HAIR

LOOKED HEALTHIER, MORE VOLUME.

SHINES MORE AND FEELS

STRONGER. NOTICED HAIR GROW IN

MY HAIR LINE AREA.

** SUBJECT = 27

I HAD LESS HAIR LOSS. FOR THAT USING EVERYDAY MADE MY HAIR

IT WAS WONDERFUL. FEEL DIRTY AND FRIZZY. TOO

MUCH WORK EVERY DAY.

** SUBJECT = 28

IT MADE MY HAIR SOFT AND FULL. THE SMELL OF THE SPRAY.

** SUBJECT = 31

THE SPRAY AND THE PILL... SHAMPOO IS NOT GREAT. VERY

HARD TO RINSE.

Page 17 of 46

08/23/17




LIKE DISLIKE

------------------------------ ------------------------------

** SUBJECT = 32

SHAMPOO AND CONDITIONER WERE BRUSHES WERE TOO TIME

EASY TO USE. CONSUMING WITH LITTLE RESULT.

** SUBJECT = 33

EASY TO USE. THEY DIDN'T HELP THE WAY I

THOUGHT THEY WOULD.

Page 18 of 46

IRSI - HAIR CARE REGIMEN STUDY #4141SH0617 8/23/17

MEDICAL HISTORY

HGT SUBJECTS HEIGHT

Valid Cum

Value Label Value Frequency Percent Percent Percent

61.0 1 3.3 3.3 3.3

61.5 1 3.3 3.3 6.7

62.0 4 13.3 13.3 20.0

63.0 3 10.0 10.0 30.0

64.0 3 10.0 10.0 40.0

65.0 2 6.7 6.7 46.7

66.0 2 6.7 6.7 53.3

67.0 2 6.7 6.7 60.0

68.0 2 6.7 6.7 66.7

69.0 2 6.7 6.7 73.3

70.0 2 6.7 6.7 80.0

72.0 2 6.7 6.7 86.7

73.0 2 6.7 6.7 93.3

74.0 2 6.7 6.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0

Mean 66.650 Std Err .755 Median 66.000

Std Dev 4.134 Variance 17.089

Valid Cases 30 Missing Cases 0

Page 19 of 46


MEDICAL HISTORY

WGT SUBJECTS WEIGHT

Valid Cum


112 1 3.3 3.3 3.3

120 1 3.3 3.3 6.7

122 1 3.3 3.3 10.0

126 1 3.3 3.3 13.3

128 1 3.3 3.3 16.7

130 1 3.3 3.3 20.0

135 2 6.7 6.7 26.7

138 1 3.3 3.3 30.0

150 2 6.7 6.7 36.7

153 1 3.3 3.3 40.0

162 1 3.3 3.3 43.3

170 1 3.3 3.3 46.7

180 2 6.7 6.7 53.3

183 1 3.3 3.3 56.7

189 1 3.3 3.3 60.0

195 1 3.3 3.3 63.3

196 1 3.3 3.3 66.7

200 2 6.7 6.7 73.3

210 3 10.0 10.0 83.3

220 1 3.3 3.3 86.7

230 1 3.3 3.3 90.0

265 1 3.3 3.3 93.3

266 1 3.3 3.3 96.7

270 1 3.3 3.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0

Mean 177.833 Std Err 8.251 Median 180.000



Page 20 of 46


MEDICAL HISTORY

AGE SUBJECTS AGE

Valid Cum


37 2 6.7 6.7 6.7

40 1 3.3 3.3 10.0

44 2 6.7 6.7 16.7

45 1 3.3 3.3 20.0

48 1 3.3 3.3 23.3

51 1 3.3 3.3 26.7

55 1 3.3 3.3 30.0

56 2 6.7 6.7 36.7

57 1 3.3 3.3 40.0

58 4 13.3 13.3 53.3

59 2 6.7 6.7 60.0

60 2 6.7 6.7 66.7

61 2 6.7 6.7 73.3

62 3 10.0 10.0 83.3

63 2 6.7 6.7 90.0

64 1 3.3 3.3 93.3

65 2 6.7 6.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0

Mean 55.600 Std Err 1.524 Median 58.000



- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

SEX SUBJECTS SEX

Valid Cum


MALE 1.00 14 46.7 46.7 46.7

FEMALE 2.00 16 53.3 53.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 21 of 46


MEDICAL HISTORY

ETHN SUBJECTS ETHNICITY

Valid Cum


HISPANIC 1.00 2 6.7 6.7 6.7

NON-HISPANIC 2.00 28 93.3 93.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

RACE SUBJECTS RACE

Valid Cum


WHITE 1.00 25 83.3 86.2 86.2

ASIAN 3.00 4 13.3 13.8 100.0

. 1 3.3 MISSING

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

FACE SUBJECTS FACIAL SKIN

Valid Cum


DRY 1.00 2 6.7 6.7 6.7

OILY 2.00 2 6.7 6.7 13.3

NORMAL 3.00 14 46.7 46.7 60.0

COMBO 4.00 12 40.0 40.0 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 22 of 46


MEDICAL HISTORY

BODY SUBJECTS BODY SKIN

Valid Cum


NORMAL 1.00 24 80.0 82.8 82.8

DRY 2.00 5 16.7 17.2 100.0

. 1 3.3 MISSING

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

FITZ SUBJECTS FITZPATRICK SCORE

Valid Cum


2 5 16.7 16.7 16.7

3 17 56.7 56.7 73.3

4 8 26.7 26.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Std Dev .662 Variance .438


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

SKIN SUBJECT HAS SENSITIVE SKIN

Valid Cum


YES 1.00 8 26.7 26.7 26.7

NO 2.00 22 73.3 73.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 23 of 46


MEDICAL HISTORY

EYES SUBJECT HAS SENSITIVE EYES

Valid Cum


YES 1.00 5 16.7 16.7 16.7

NO 2.00 25 83.3 83.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

LENS SUBJECT WEARS CONTACTS

Valid Cum


YES 1.00 5 16.7 16.7 16.7

NO 2.00 25 83.3 83.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

OCCU SUBJECTS OCCUPATION

Valid Cum


RETIRED 2.00 8 26.7 26.7 26.7

HOMEMAKER 3.00 2 6.7 6.7 33.3

UNEMPLOYED 4.00 1 3.3 3.3 36.7

EMPLOYED 5.00 19 63.3 63.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 24 of 46


TOLERANCE AND INSTRUMENTS

Paired samples t-test: SHIN0 BASE - HAIRSHINE/LUSTER

SHIN6 WK 6 - HAIRSHINE/LUSTER

Variable Number Standard Standard

of Cases Mean Deviation Error

SHIN0 30 1.9500 .402 .073

SHIN6 30 2.6500 .397 .073

(Difference) Standard Standard | 2-Tail | t Degrees of 2-Tail

Mean Deviation Error | Corr. Prob. | Value Freedom Prob.

| |

-.7000 .362 .066 | .589 .001 | -10.59 29 .000

Paired samples t-test: VOLM0 BASE - VOLUME (FULLNESS)

VOLM6 WK 6 - VOLUME (FULLNESS)



VOLM0 30 2.1333 .524 .096

VOLM6 30 2.4833 .533 .097



| |

-.3500 .575 .105 | .409 .025 | -3.34 29 .002

Paired samples t-test: SOFT0 BASE - HAIR SOFTNESS

SOFT6 WK 6 - HAIR SOFTNESS



SOFT0 30 2.0833 .396 .072

SOFT6 30 2.7333 .410 .075



| |

-.6500 .511 .093 | .195 .302 | -6.97 29 .000

Page 25 of 46



Paired samples t-test: SCLP0 BASE - SCALP HEALTH

SCLP6 WK 6 - SCALP HEALTH



SCLP0 30 2.6833 .464 .085

SCLP6 30 2.9667 .370 .068



| |

-.2833 .552 .101 | .137 .469 | -2.81 29 .009

Paired samples t-test: PHPH0 BASE - pH READING

PHPH6 WK 6 - pH READING



PHPH0 30 5.7200 .471 .086

PHPH6 30 5.2127 .605 .111



| |

.5073 .587 .107 | .428 .018 | 4.73 29 .000

Paired samples t-test: CORN0 BASE - CORNEOMETER

CORN6 WK 6 - CORNEOMETER



CORN0 30 25.3900 19.325 3.528

CORN6 30 23.8000 18.231 3.328



| |

1.5900 18.006 3.288 | .542 .002 | .48 29 .632

Page 26 of 46



Paired samples t-test: HEMO0 BASE - SIASCOPE (HEMOGLOBIN)

HEMO6 WK 6 - SIASCOPE (HEMOGLOBIN)



HEMO0 29 221.0441 21.328 3.960

HEMO6 29 192.5145 28.595 5.310



| |

28.5297 27.597 5.125 | .419 .024 | 5.57 28 .000

Paired samples t-test: VM0 BASE - VAPOMETER

VM6 WK 6 - VAPOMETER



VM0 30 22.1567 11.301 2.063

VM6 30 13.3133 4.172 .762



| |

8.8433 11.395 2.080 | .162 .393 | 4.25 29 .000

Page 27 of 46



ISHIN6 IMPRV WK 6 - HAIRSHINE/LUSTER

Valid Cum


IMPROVED 1.00 28 93.3 93.3 93.3

SAME 2.00 2 6.7 6.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IVOLM6 IMPRV WK 6 - VOLUME (FULLNESS)

Valid Cum


IMPROVED 1.00 20 66.7 66.7 66.7

SAME 2.00 6 20.0 20.0 86.7

WORSE 3.00 4 13.3 13.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ISOFT6 IMPRV WK 6 - HAIR SOFTNESS

Valid Cum


IMPROVED 1.00 24 80.0 80.0 80.0

SAME 2.00 6 20.0 20.0 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ISCLP6 IMPRV WK 6 - SCALP HEALTH

Valid Cum


IMPROVED 1.00 12 40.0 40.0 40.0

SAME 2.00 14 46.7 46.7 86.7

WORSE 3.00 4 13.3 13.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 28 of 46



IPHPH6 IMPRV WK 6 - pH READING

Valid Cum


IMPROVED 1.00 7 23.3 23.3 23.3

WORSE 3.00 23 76.7 76.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

ICORN6 IMPRV WK 6 - CORNEOMETER

Valid Cum


IMPROVED 1.00 11 36.7 36.7 36.7

WORSE 3.00 19 63.3 63.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IHEMO6 IMPRV WK 6 - SIASCOPE (HEMOGLOBIN)

Valid Cum


IMPROVED 1.00 26 86.7 89.7 89.7

WORSE 3.00 3 10.0 10.3 100.0

. 1 3.3 MISSING

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

IVM6 IMPRV WK 6 - VAPOMETER

Valid Cum


IMPROVED 1.00 29 96.7 96.7 96.7

WORSE 3.00 1 3.3 3.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0


Page 29 of 46



Number of Valid Observations (Listwise) = 29.00

Variable SHIN0 BASE - HAIRSHINE/LUSTER

Mean 1.950 S.E. Mean .073


Kurtosis 2.022 S.E. Kurt .833

Skewness -.240 S.E. Skew .427

Range 2.000 Minimum 1.0

Maximum 3.0 Sum 58.500

Valid Observations - 30 Missing Observations - 0

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable VOLM0 BASE - VOLUME (FULLNESS)



Kurtosis .580 S.E. Kurt .833





- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable SOFT0 BASE - HAIR SOFTNESS




Skewness .132 S.E. Skew .427




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable SCLP0 BASE - SCALP HEALTH








Page 30 of 46




Variable PHPH0 BASE - pH READING



Kurtosis -.211 S.E. Kurt .833





- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable CORN0 BASE - CORNEOMETER

Mean 25.390 S.E. Mean 3.528







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable HEMO0 BASE - SIASCOPE (HEMOGLOBIN)

Mean 221.044 S.E. Mean 3.960





Maximum 259.34 Sum 6410.280


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -


Variable VM0 BASE - VAPOMETER

Mean 22.157 S.E. Mean 2.063



Skewness 1.414 S.E. Skew .427



Page 31 of 46


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable SHIN6 WK 6 - HAIRSHINE/LUSTER








Page 32 of 46




Variable VOLM6 WK 6 - VOLUME (FULLNESS)








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable SOFT6 WK 6 - HAIR SOFTNESS








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable SCLP6 WK 6 - SCALP HEALTH








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PHPH6 WK 6 - pH READING








Page 33 of 46




Variable CORN6 WK 6 - CORNEOMETER

Mean 23.800 S.E. Mean 3.328







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable HEMO6 WK 6 - SIASCOPE (HEMOGLOBIN)

Mean 192.514 S.E. Mean 5.310





Maximum 275.21 Sum 5582.920


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable VM6 WK 6 - VAPOMETER

Mean 13.313 S.E. Mean .762







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DSHIN6 DIFF WK 6 - HAIRSHINE/LUSTER

Mean .700 S.E. Mean .066




Range 1.500 Minimum .00



Page 34 of 46

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DVOLM6 DIFF WK 6 - VOLUME (FULLNESS)





Range 2.500 Minimum -1.00



Page 35 of 46




Variable DSOFT6 DIFF WK 6 - HAIR SOFTNESS








- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DSCLP6 DIFF WK 6 - SCALP HEALTH





Range 2.000 Minimum -.50



- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DPHPH6 DIFF WK 6 - pH READING

Mean -.507 S.E. Mean .107





Maximum .56 Sum -15.220


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DCORN6 DIFF WK 6 - CORNEOMETER

Mean -1.590 S.E. Mean 3.288





Maximum 43.60 Sum -47.700


Page 36 of 46




Variable DHEMO6 DIFF WK 6 - SIASCOPE (HEMOGLOBIN)

Mean -28.530 S.E. Mean 5.125





Maximum 62.31 Sum -827.360


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable DVM6 DIFF WK 6 - VAPOMETER

Mean -8.843 S.E. Mean 2.080



Skewness -1.520 S.E. Skew .427


Maximum 12.90 Sum -265.300


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PSHIN6 % CHG WK 6 - HAIRSHINE/LUSTER

Mean 40.222 S.E. Mean 5.483





Maximum 150.00 Sum 1206.667


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PVOLM6 % CHG WK 6 - VOLUME (FULLNESS)

Mean 22.722 S.E. Mean 6.854





Maximum 150.00 Sum 681.667


Page 37 of 46

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PSOFT6 % CHG WK 6 - HAIR SOFTNESS

Mean 36.722 S.E. Mean 8.197





Maximum 250.00 Sum 1101.667


Page 38 of 46




Variable PSCLP6 % CHG WK 6 - SCALP HEALTH

Mean 13.694 S.E. Mean 4.410







- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PPHPH6 % CHG WK 6 - pH READING

Mean -8.619 S.E. Mean 1.876





Maximum 11.46 Sum -258.564


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PCORN6 % CHG WK 6 - CORNEOMETER

Mean 29.400 S.E. Mean 23.117





Maximum 446.38 Sum 882.006


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PHEMO6 % CHG WK 6 - SIASCOPE (HEMOGLOBIN)

Mean -12.571 S.E. Mean 2.399





Maximum 29.27 Sum -364.568


Page 39 of 46

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Variable PVM6 % CHG WK 6 - VAPOMETER

Mean -29.433 S.E. Mean 5.634





Maximum 88.36 Sum -882.980


Page 40 of 46


QUESTIONNAIRE

Q1 Q1 IMPROVED SCALP HYDRATION

Valid Cum


STRONG AGREE 1 5 16.7 16.7 16.7

AGREE 2 10 33.3 33.3 50.0

NEUTRAL 3 13 43.3 43.3 93.3

DISAGREE 4 2 6.7 6.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Q2 Q2 IMPROVED HAIR SHINE/LUSTER

Valid Cum


STRONG AGREE 1 1 3.3 3.3 3.3

AGREE 2 18 60.0 60.0 63.3

NEUTRAL 3 6 20.0 20.0 83.3

DISAGREE 4 5 16.7 16.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Q3 Q3 IMPROVED HAIR FULLNESS (VOLUME)

Valid Cum


STRONG AGREE 1 9 30.0 30.0 30.0

AGREE 2 10 33.3 33.3 63.3

NEUTRAL 3 4 13.3 13.3 76.7

DISAGREE 4 7 23.3 23.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0




Page 41 of 46


QUESTIONNAIRE

Q4 Q4 IMPROVED HAIR SOFTNESS

Valid Cum


STRONG AGREE 1 6 20.0 20.0 20.0

AGREE 2 17 56.7 56.7 76.7

NEUTRAL 3 3 10.0 10.0 86.7

DISAGREE 4 4 13.3 13.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Q5 Q5 IMPROVED SCALP HEALTH

Valid Cum


STRONG AGREE 1 5 16.7 16.7 16.7

AGREE 2 3 10.0 10.0 26.7

NEUTRAL 3 22 73.3 73.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Q6 Q6 REDUCED HAIR LOSS IN SHOWER

Valid Cum


STRONG AGREE 1 4 13.3 13.3 13.3

AGREE 2 12 40.0 40.0 53.3

NEUTRAL 3 7 23.3 23.3 76.7

DISAGREE 4 7 23.3 23.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0




Page 42 of 46


QUESTIONNAIRE

Q7 Q7 REDUCED HAIR LOSS IN BRUSH/COMB

Valid Cum


STRONG AGREE 1 5 16.7 16.7 16.7

AGREE 2 13 43.3 43.3 60.0

NEUTRAL 3 7 23.3 23.3 83.3

DISAGREE 4 5 16.7 16.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0




- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Q8 Q8 WOULD PURCHASE

Valid Cum


STRONG AGREE 1 5 16.7 16.7 16.7

AGREE 2 7 23.3 23.3 40.0

NEUTRAL 3 14 46.7 46.7 86.7

DISAGREE 4 3 10.0 10.0 96.7

STRONG DISAGREE 5 1 3.3 3.3 100.0

------- ------- -------

TOTAL 30 100.0 100.0




Page 43 of 46


QUESTIONNAIRE

Q9 Q9 WOULD RECOMMEND

Valid Cum


STRONG AGREE 1 5 16.7 16.7 16.7

AGREE 2 9 30.0 30.0 46.7

NEUTRAL 3 8 26.7 26.7 73.3

DISAGREE 4 8 26.7 26.7 100.0

------- ------- -------

TOTAL 30 100.0 100.0




Page 44 of 46


QUESTIONNAIRE

XQ1 Q1 IMPROVED SCALP HYDRATION

Valid Cum


POSITIVE 1.00 15 50.0 50.0 50.0

NEUTRAL NEGATIVE 2.00 15 50.0 50.0 100.0

------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ2 Q2 IMPROVED HAIR SHINE/LUSTER

Valid Cum


POSITIVE 1.00 19 63.3 63.3 63.3


------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ3 Q3 IMPROVED HAIR FULLNESS (VOLUME)

Valid Cum


POSITIVE 1.00 19 63.3 63.3 63.3


------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ4 Q4 IMPROVED HAIR SOFTNESS

Valid Cum


POSITIVE 1.00 23 76.7 76.7 76.7


------- ------- -------

TOTAL 30 100.0 100.0


Page 45 of 46


QUESTIONNAIRE

XQ5 Q5 IMPROVED SCALP HEALTH

Valid Cum


POSITIVE 1.00 8 26.7 26.7 26.7


------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ6 Q6 REDUCED HAIR LOSS IN SHOWER

Valid Cum


POSITIVE 1.00 16 53.3 53.3 53.3


------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ7 Q7 REDUCED HAIR LOSS IN BRUSH/COMB

Valid Cum


POSITIVE 1.00 18 60.0 60.0 60.0


------- ------- -------

TOTAL 30 100.0 100.0


- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

XQ8 Q8 WOULD PURCHASE

Valid Cum


POSITIVE 1.00 12 40.0 40.0 40.0


------- ------- -------

TOTAL 30 100.0 100.0


Page 46 of 46


QUESTIONNAIRE

XQ9 Q9 WOULD RECOMMEND

Valid Cum


POSITIVE 1.00 14 46.7 46.7 46.7


------- ------- -------

TOTAL 30 100.0 100.0


Documents

A Six-Week Clinical Study to Determine the Effectiveness of a Hair …€¦ · Subjective questionnaire Reduces water loss of scalp TEWL Improves scalp hemoglobin (i.e. oxygenation)