P714Comparison of a 3-step acne system containing solubilized benzoyl per-oxide versus benzoyl peroxide/clindamycin: A multicenter, investigator-blind, randomized study

Diane Thiboutot, MD, PhD, Penn State University College of Medicine, Hershey,PA, United States; Alan Shalita, MD, SUNY Downstate Medical Center, Brooklyn,NY, United States; James Del Rosso, DO, Las Vegas Skin and Cancer Clinics, LasVegas, NV, United States; Lawrence Eichenfield, MD, Children’s Specialists of SanDiego, San Diego, CA, United States

Background: Benzoyl peroxide (BPO) is poorly soluble and tends to aggregate intoclusters that hinder its bioavailability and follicular penetration. A 3-step acne systemhas been developed that contains a novel solubilized 5% BPO formulation (togetherwith a proprietary salicylic acid cleanser and salicylic acid toner) which aims toenhance both the bioavailability and follicular penetration of BPO. Early clinical datahave shown that the solubilized 5% BPO formulation can result in a greaterreduction in acne lesion counts in the early weeks of treatment compared with acombination BPO/antibiotic product. We have now evaluated these treatments in alarger group of patients and over a longer period of time.

Methods: Patients were eligible for enrollment if they had mild to moderate facialacne vulgaris (10-100 noninflammatory lesions, 17-40 inflammatory lesions, and upto two nodulocystic lesions). They were randomly assigned to 10 weeks of facialtreatment with one of the following: the 3-step acne system (proprietary 2% salicylicacid cleanser twice daily 1 solubilized 5% BPO gel twice daily 1 proprietary 2%salicylic acid toner once daily) or control cleanser twice daily 1 5% BPO/1%clindamycin twice daily.

Results: A total of 139 patients were enrolled. They had a mean of 52 noninflam-matory acne lesions and 28 inflammatory acne lesions at baseline. The 3-step acnesystem was associated with a numerically greater reduction in noninflammatorylesion count compared to BPO/clindamycin at weeks 2, 4, and 6 (a mean of 27% vs13%, 39% vs 25%, and 40% vs 33%, respectively [all nonsignificant]) and acomparable reduction at week 10 (42% vs 42%). Both regimens were associatedwith comparable reductions in inflammatory lesion count at all timepoints. Bothtreatments were generally well tolerated with mean levels of erythema, dryness,peeling, burning/stinging, and itching less than mild (on a scale of none, mild,moderate, and severe) in both groups at all timepoints.

Conclusions: Compared with BPO/clindamycin, the 3-step acne system offersnumerically greater reductions in the noninflammatory lesion count in the earlyweeks of treatment in the absence of an antibiotic. It is probable that thisimprovement in efficacy is a result of the solubilized BPO formulation that enhancesthe bioavailability and follicular penetration of BPO.

Commercial support: OMP, Inc.

P716The prevalence of acne in French girls aged between 13 and 23

Florence Poli, MD, Dermatologyst, Paris, IDF, France; Charles Taieb, MD, PierreFabre, Public Health, Boulogne Billancourt, IDF, France; Marco Ambonati, MD,Laboratoires Dermatologiques Ducray, Lavaur, Midi Pyrenees, France; SamiBoussetta, MD, Pierre Fabre, Public Health, Boulogne Billancourt, IDF, France

Background: Acne represents one of the most common reasons for consulting inliberal dermatology. The most recent large French study was carried out onadolescents attending school in mainland France during the school year 1996 to1997, and excluded young people who were not attending school. No study hasbeen carried out in France on the population of girls aged between 13 and 23.

Objective: To describe the prevalence, levels of care, and means of treating acne inadolescents in France today.

Methods: A representative sample of the population of girls between 13 and 23 yearsof age living in France was constituted by the CSA Sante institute, using the quotamethod (age, geographic location of residence, and professional activity of the headof the family). Questions were asked about skin type, skin phototype, the presenceand severity of acne, family history of acne, and therapeutic habits.

Results: Within the framework of this study, 1003 girls were questioned and twosubpopulations were constituted: the first group was made up of girls aged between13 and 16, and the second of girls aged between 17 and 23. The groups claimed tohave dry skin (12.5%), combination skin (49%), or oily skin (38.2%). There was nodifference observed according to age group. They declare their skin to be very pale(14.3%), pale (61.7%), dark (22.51%), and and very dark (1.5%), with no differenceobserved according to age group. Among the adolescents, 79% of the 13- to 23-year-olds claim to have or have had acne, and among them, 49.9% of the subjects judgetheir acne to be moderate, 43.3% benign, and 6.8% severe. For 55.4 % of them, theirsiblings over the age of 12 had acne, for 16.6% there were maternal antecedents, andfor 7%, paternal antecedents. One girl out of every two claims to have acne at themoment, and 53% of these judge their acne to be moderate, 39% benign, and 7%severe. Judgement with regard to severity is equal, whether the acne is old orcurrent. Sixty-four percent of the young acne sufferers are under exclusively localtreatment, 6% have an exclusively oral treatment, and 30% are being treated withcombined local and oral treatments. Treatment methods are statistically differentaccording to age (P \.001): 78% of the 13- to 16-year-olds use an exclusively localtreatment versus 49% among the 17- to 23-year-olds, and similarly 4% of the 13- to16-year-olds take an exclusively oral treatment versus 8 % of the 17- to 23-year-olds.

Discussion: At the moment, therefore, almost 2,000,000 French girls between 13and 23 years of age suffer from acne, and among them almost 600,000 have notreatment or care. This figure leads us to think that dermatologists should, without adoubt, be even more present in the field of acne treatment. Appropriate informationand even a therapeutic educational program would be welcomed.

Commercial support: 35% sponsored by Ducray.

P717Can delivery be enhanced and skin irritation minimized using a lowerconcentration of benzoyl peroxide in a fixed combination product?

Daniel Bucks, Dow Pharmaceutical Sciences, Inc., Petaluma, CA, United States;Arturo Angel, Dow Pharmaceutical Sciences, Inc., Petaluma, CA, United States;James Del Rosso, DO, University of NV, Las Vegas, Las Vegas, NV, UnitedStates; Karen Yu, PharmD, Dow Pharmaceutical Sciences, Inc., Petaluma, CA,United States

Background: Currently available fixed combination products of clindamycin 1% andbenzoyl peroxide (BPO) 5% (clindamycin 1%-BPO 5%) are commonly used in thetreatment of acne. Although these formulations are proven to be effective, signs andsymptoms of cutaneous irritation limit use in some subjects, with the frequencyand/or severity of skin tolerability reactions believed to be caused by the content ofBPO and vehicle excipients. The BPO in clindamycin 1%-BPO 5% is maintained insuspension using surfactants; clindamycin is maintained in solution. Many surfac-tants and BPO itself have been shown to be skin irritants. Studies have demonstratedthat irritation caused by BPO is dose-dependent; lower, less irritating concentrationsof BPO might be equally effective, but data on comparative efficacy are lacking.

Objective: To identify a surfactant-free, alcohol-free clindamycin phosphate 1.2%and BPO 2.5% aqueous gel (clindamycin-BPO 2.5%) with formulation-specificproperties that enhances percutaneous delivery of micronized BPO and reducescutaneous irritation.

Methods: The first study identified the optimal formulation causing minimalirritation; a single center, evaluator-blind determination of cumulative irritationpotential following repeated topical application to healthy subjects of variousBPO/vehicle ratios. In a second study, BPO delivery from the clindamycin-BPO 2.5%was compared with two currently available clindamycin 1%-BPO 5% products in anin vitro human skin permeation model.

Results: A significant reduction in irritation was seen when the BPO concentrationwas halved from 5% to 2.5%. BPO levels below 2.5% showed negligible reduction inirritation scores as compared to BPO 2.5%. As a result, the 2.5% BPO concentrationwas used in the second study. Delivery of benzoic acid using the combinationformulation containing BP0 2.5% was equivalent to that delivered from both BPO5%-containing formulations over the 24-hour duration of exposure.

Conclusions: A surfactant-free, preservative-free aqueous gel containing 2.5% BPO and1.2% clindamycin phosphate has been developed with percutaneous delivery of BPOequivalent to that seen with fixed combination products containing BPO 5%.Clindamycin-BPO 2.5% offers the potential for similar efficacy and a more favorabletolerability profile as compared to products containing higher concentrations of BPO.

Commercial support: 100% sponsored by Arcutis Pharmaceuticals, Inc.

MARCH 2009

P715Psychometric validation of the oily skin self assessment scale (OSSAS) andthe oily skin impact scale (OSIS)

Carla Mamolo, MD, Pfizer Inc., New London, CT, United States; Jane Harness, MS,Pfizer Inc., New London, CT, United States; Nicola Bonner, Mapi Values,Bollington, Cheshire, United Kingdom; Robert Arbuckle, Mapi Values,Bollington, Cheshire, United Kingdom

Objective: The Oily Skin Self Assessment Scale (OSSAS) and Oily Skin Impact Scale(OSIS) are patient-reported outcome questionnaires developed using focus groupsto assess facial oily skin severity and the impact of oily skin on emotional well-being,respectively. This study examined the psychometric properties of thesequestionnaires.

Methods: The OSSAS, OSIS, and concurrent dermatology quality of life question-naires (Skindex and AcneQoL) were administered to 202 adults with oily skin atseven sites across the United States. A subgroup of 152 participants returned 1 to 2weeks later for testeretest reliability evaluation.

Results: Of the 202 participants, 72.8% were female; 64.4% had acne in addition tooily skin. Item reduction analyses were performed on the initial 37-item OSSAS and14-item OSIS administered to participants. The OSSAS was reduced to 14 items withthree domains: (1) sensation [5 items], (2) tactile [3 items], and (3) visual [4 items],plus two individual items: (1) blotting paper and (2) overall oiliness. The OSIS wasreduced to six items with two domains: (1) annoyance [3 items] and (2) self-image[3 items]. Confirmatory factor analysis provided support for the construct validity ofthe final item-scale structures. The OSSAS and OSIS scales had acceptable itemconvergent validity (item-scale correlations, [0.40) and floor and ceiling effects(\20%). Cronbach alfa coefficients ranged from 0.83 to 0.89 for the OSSAS and 0.82to 0.87 for the OSIS, demonstrating excellent internal consistency.

The a priori criterion for testeretest reliability (ICC $ 0.7) was met for one of thethree OSSAS domains (sensation) and one of the two OSIS domains (annoyance).Correlations of the Skindex-29 and AcneQoL scales with the OSSAS (range, -0.08 to-0.38) and OSIS (range, 0.37-0.73) domain scores met content expectations for thesescales. OSSAS and OSIS domains distinguished among groups of participants whodiffered in terms of both patient reported facial oily skin severity (P \.0001) andpatient-reported bother associated with oily skin (P \.0001).

Conclusions: Following item reduction, the OSSAS and OSIS demonstrated strongconstruct validity, internal consistency, and the ability to discriminate among knowngroups in participants with a range of oily skin and acne severities. The item-reducedOSSAS and OSIS provide valid self-report measures of facial oily skin severity and theimpact of oily skin on emotional well-being, respectively.

Commercial support: 100% sponsored by Pfizer Inc.

AB16 J AM ACAD DERMATOL