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15 TH ANNUAL CONGRESS www.euro-pdt.org THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY Friday, February 12 th Saturday, February 13 th , 2016 Barcelona, Spain Program Platinum sponsor

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Page 1: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th

15 T H ANNUAL CONGRESS

www.euro-pdt.org

THE EUROPEAN SOCIETY FOR

PHOTODYNAMIC THERAPY

Friday, February 12th

Saturday, February 13th, 2016Barcelona, Spain

Program

Platinum sponsor

Page 2: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th
Page 3: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th

MEETING ORGANIZATIONCongress President

Y. Gilaberte, Huesca, Spain

Board of the Euro-PDTL.R. Braathen, Bern, Switzerland

R.-M. Szeimies, Recklinghausen, GermanyA. Sidoroff, Innsbruck, AustriaC.A. Morton, Stirling, Scotland

Scientific committeeL.R. Braathen, Bern, Switzerland

R.-M. Szeimies, Recklinghausen, GermanyA. Sidoroff, Innsbruck, AustriaC.A. Morton, Stirling, ScotlandN. Basset-Séguin, Paris, France

M.J.P. Gerritsen, Nijmegen, The NetherlandsY. Gilaberte, Huesca, Spain

P. Calzavara-Pinton, Brescia, ItalyH.C. Wulf, Copenhagen, Denmark

A.-M. Wennberg, Gothenburg, SwedenR.E. Hunger, Bern, Switzerland

Local Scientific CommitteeY. Gilaberte, Huesca, SpainA. Toll, Barcelona, SpainC. Guillen, Valencia, SpainS. Nonell, Barcelona, Spain

Congress secretariat and hotel reservationVISTA - EURO-PDT 2016

24 rue Erlanger - 75016 ParisTel. : +33 (0)1 46 43 33 42Fax : +33 (0)1 46 24 88 38

Email : [email protected]

Congress venueAC Barcelona Forum Hotel

Paseo Taulat 278Barcelona, Spain 1

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Page 5: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th

Prof. Lasse R. BraathenPresident of EURO-PDT

Welcome to the 15th Annual Congress of the EuropeanSociety for Photodynamic Therapy in Dermatology,EURO-PDT, the world’s largest congress devoted toresearch and clinical use of PDT in Dermatology.

PDT is a well established successful method fortreatment of non-melanoma skin cancer. It is furthermoredocumented as successful for other indications, forexample ; acne, skin rejuvenation,various skin infections,skin lymphomas and other dermatological disorders.

With the introduction of the innovative DL-PDT the PDTprocedure is simplified without loss of clinical effi-cacy.

The speakers present the latest hottest news of theirresearch and I am convinced that we will learn a lotabout new developments of PDT.

Of course you also have a unique opportunity to discussthe research results and the new developments withyour colleagues.

Welcome to Barcelona

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Page 7: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th

Yolanda GilaberteCongress President

Dear colleagues,

On behalf of the local Organizing Committee, it is mygreat pleasure to welcome you to the 15th Congressof the European Society of Photodynamic Therapy inBarcelona.

Following the tradition of previous congresses, thismeeting has been designed to be an update of thelast progress and developments in the field of PDT fordermatologists.

Each Euro-PDT meeting offers researchers and cliniciansfrom different countries an excellent opportunitynot only to learn but also to interact and exchangeknowledge and experiences in the field of PDT.

We are certain that Barcelona will be a magnificentlocation to host such a high level meeting, with its twothousand year of history reflected in monuments,streets and museums and with its current modern,cosmopolitan and Mediterranean environment.

We hope that the scientific program fulfils yourexpectations and that the congress provides you agood opportunity to meet old colleagues and makenew friends, all of this in a charming atmosphere thatthe beautiful city of Barcelona offers to visitors.

Looking forward to welcoming you to Barcelona.

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14:00 IntroductionLasse Braathen & Yolanda Gilaberte

Welcome and PDT guidelinesLasse R. Braathen, Switzerland

Plenary session I: Epidemiology, Diagnosis & ConsensusLasse Braathen & Peter Wolf

14:10 Prevalence and risk factors of AK in Italian DermatologyoutpatientsMaria Concetta Fargnoli, Italy................................................................C1

14:20 Thin AK lesions with atypical basal cells are just as dangerousas thick onesMaite Fernández-Figueras, Spain..........................................................C2

14:30 PDT resistance factors in NMSCAngeles Juarranz, Spain .......................................................................C3

14:40 Structured expert consensus on AK:up-to-date treatment algorithmPiergiacomo Calzavara Pinton, Italy ......................................................C4

Plenary session II: AK Lesion versus field therapySkin preparationSally Ibbotson & Celeste Brito

14:50 Field or lesion-treatment? What's the best?Thomas Dirschka, Germany ..................................................................C5

15:00 Retrospective analysis comparing the impact of keratolyticor physical pretreatment on the efficacy and safety of PDTfor AK with Methylaminolaevulinate (MAL)Patrick Gholam, Germany .....................................................................C6

15:10 Physical pretreatment regimens to enhance PpIX uptakeand PDT reactions in normal skinMerete Haedersdal, Denmark...............................................................C7

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15:20 Microneedling assisted DL PDT for AKMartina Hund, Germany .......................................................................C8

15:30 Multi-modal therapy approaches in PDTPeter Arne Gerber, Germany ................................................................C9

15:40 Break and poster session

Plenary session III: Efficacy dataMerete Haedersdal & Claas Ulrich

16:10 Potential impact of patient vitamin D status in AK responseto MAL-PDTLuis Torezan, Brazil .............................................................................C10

16:20 Ingenol mebutate vs PDT in AK patientsMaria Teresa Rossi, Italy ......................................................................C11

16:30 Histologic AK dysplasia has no relation to AKthickness - consequences for treatmentIda Heerfordt, Denmark......................................................................C12

16:40 One week of 5-FU followed by DL-PDT:a combination studyChristopher Nissen, Denmark .............................................................C13

16:50 Bucher’s indirect comparison of different treatments formultiple AKRolf-Markus Szeimies, Germany .........................................................C14

17:00 DL PDT for AK: high maintenance of clearance at one yearMaria Concetta Fargnoli, Italy .............................................................C15

17:10 DL PDT for AK : histologic assessment of efficacyBeni Grinblat, Brazil ............................................................................C16

17:20 Retrospective analysis of DL-PDT and cPDT in AK with 3D imagingCarmen Cantisani, Italy .......................................................................C17

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Plenary session IV: DL-PDT : how I do itYolanda Gilaberte & Piergiacomo Calzavara-Pinton

17:30 Practical approach to the use of DL-PDT with topical methylaminolevulinate for AK: a European consensusColin Morton, UK................................................................................C18

17:40 DL-PDT vs blue light cPDT for AKChristophe Bedane, France ................................................................C19

17:50 DL-PDT can be administered within the usualconsultation durationAna Julia García-Malinis, Spain ..........................................................C20

18:00 DL-PDT: handling a safe and simple protocolJacques Savary, France.......................................................................C21

18:10 DL-PDT experience in DundeeSally Ibbotson, UK..............................................................................C22

18:20 One year experience of DL-PDT in BelgiumMuriel Creusot, Belgium .....................................................................C23

18:30 PDT in Sassuolo, Modena: present practice and future plansMarco Curci, Italy ...............................................................................C24

18:40 Can DL-PDT work indoors?Hans Christian Wulf, Denmark.............................................................C25

18:50 DL-PDT experience in PadovaStefano Piaserico, Italy .......................................................................C26

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Plenary session V: AK PreventionAnn-Marie Wennberg & Colin Morton

09:00 Occupational skin cancer and preventionClaas Ulrich, Germany ........................................................................C27

09:10 Primary Prevention of Skin Dysplasia in Renal TransplantRecipients With PDT: A Randomized Controlled TrialKatryn Togsverd-Bo, Denmark ............................................................C28

Plenary session VI: BCC

09:20 Fractional laser-mediated PDT of high-risk BCC-a randomizedclinical trial.Uwe Paasch, Germany .......................................................................C29

09:30 10 years of PDT experience for AK and BCC in PortugalCeleste Brito, Portugal ........................................................................C30

Plenary session VII: Skin rejuvenation and other indicationsRolf-Markus Szeimies & Hans-Christian Wulf

09:40 New approaches to antimicrobial photodynamic therapySanti Nonell, Spain.............................................................................C31

09:50 MAL PDT for onychomycosis: a multicenter, randomized,controlled, clinical trialYolanda Gilaberte, Spain ...................................................................C32

10:00 Break and poster session

10:30 DL-PDT with MAL cream for large-scale photodamaged skin,based on the concept of ‘actinic field damage’Peter Bjerring, Denmark ......................................................................C33

10:40 Aesthetic indications for PDTMatteo Tretti Clementoni, Italy ...........................................................C34

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10:50 Management of post-treatment erythemaPeter Arne Gerber, Germany ..............................................................C35

11:00 Scalp nerve blocks for pain management during large field PDTSigrid Karrer, Germany........................................................................C36

11:10 DL-PDT with MAL in the treatment of actinic cheilitisDario Fai, Italy .....................................................................................C37

11:20 Cutaneous leishmaniasis responds to DL-PDT: proof of conceptfor a novel self-administered therapeutic modalityClaes D. Enk, Israel..............................................................................C38

11:30 PDT for acneAnn-Marie Wennberg, Sweden .........................................................C39

11:40 Poster communicationLasse Braathen & Rolf-Markus Szeimies

11:50 End and awards

15TH Annual CongressBarcelona, Spain

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AK ..........Actinic KeratosisALA ........Aminolevulinic AcidBCC.........Basal Cell CarcinomanBCC.......Nodular BCCsBCC .......Superficial BCCCR...........Complete responseFx ...........FractionalDL-PDT ....Daylight PDT

LED .........Light-Emitting DiodeMAL........Methyl AminolevulinateNMSC......Non-Melanoma Skin CancerPDT .........Photodynamic TherapyPpIX........Protoporphyrin IXSCC.........Squamous Cell CarcinomaSD...........Standard DeviationVAS.........Visual Analogic Scale

Glossary

ABSTRACTS

Page 14: THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY · YolandaGilaberte CongressPresident Dearcolleagues, OnbehalfofthelocalOrganizingCommittee,itismy greatpleasuretowelcomeyoutothe15 th

Aim of the study was to assess AK prevalence and risk factors in patients aged≥30 years attending 24 Italian dermatology outpatient clinics. Prevalence of AKwas assessed in the whole study population. Risk factors were evaluated in pa-tients with available data for all the variables of interest, after redefining AK to in-clude both current lesions and a history of AK. The study population included8461 patients, of which 7284 were included in the analysis of prevalence. Theprevalence of AK in dermatology outpatients was 27.4% (95% confidence in-terval, 26.4–28.4%), with 34.3% in males and 20.0% in females (p <0.001).

Risk factor population included 4604 patients. On multivariate analysis, inde-pendent risk factors for AK were: age (ORs 4.8 to 41.1, increasing with ageing),other previous NMSC (OR 2.7), residence in Southern Italy and Sardinia (OR 2.6),working outdoor >6 hours/day (OR 1.9), male gender (OR 1.7), face solar lenti-gos (OR 1.6), light hair (OR 1.5), prolonged recreational outdoor activities (OR1.4), light eyes (OR 1.3), skin phototype I/II (OR 1.3), and alcohol consumption(OR 1.2). BMI ≥25.0 (OR 0.6), regular sunscreen use (OR 0.7), and lower educa-tional level (OR 0.8) were independent protective factors. The prevalence of AKwas high in Italian dermatology outpatients. We confirmed several well-known AKrisk factors and revealed possible novel risk and protective factors for AK.

Prevalence and risk factors of AKin italian dermatology outpatients

Maria Concetta FargnoliL’Aquila, Italy

E. Benati, F. Borgia, A. Carbone, S. Chimenti, L. Donato, E. Frigerio, E. Moggio,P. Broganelli, G. Girolomoni, G. Micali, A. Parodi, S. Piaserico, G. Pistone, C. Potenza, M. Puviani,

M. Raucci, S. Vaccari, S. Veglio, A. Zanca, K. Peris

Key Words:AK, Prevalence, Risk factors, Outpatients

C1

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All actinic keratoses (AK) start with atypical transformation of the basal layer.Eventually, some regress whereas others transform into invasive squamous cellcarcinoma (iSCC). This was considered to occur only following completetransformation of the epidermis through three stages, akin to the “classic pathway”in HPV-associated iSCC. Accordingly, only thick and hyperkeratotic lesions wouldbe high-risk lesions, a final stage before iSCC development. After evaluation of196 consecutive biopsy specimens, we demonstrated that in most cases iSCCarises directly from AK with dysplasia limited to the basal layer, akin to the“differentiated pathway” in iSCC of the vulva and oral mucosa. Extension of basaldysplasia along the follicular epithelium was also common and often the originof iSCC. Thus, clinically thin lesions can no longer be considered as low risk.Furthermore, direct transformation from the cancer field -also characterized bybasal dysplasia- cannot be ruled out.

Thin AK lesions with atypical basal cellsare just as dangerous as thick ones

María Teresa Fernández FiguerasBadalona, Spain

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One of the problems of PDT, as well as other cancer therapies, is the persistenceof some tumors after treatment. We have selected resistant cells from squamouscell carcinoma (SCC) and basal cell carcinoma (BCC) cell lines by repeated MAL-PDT treatments in order to evaluate factors implicated in a reduced response toPDT. Resistant cells present a more fibroblastic morphology, higher expression ofcell-substrate adhesion proteins and higher ability to induce tumors in immuno-deficiency mice. The evaluation of potential genes implicated in a decreasedresponse of SCC to MAL-PDT reveals genomic imbalances in CCND1, EFGR andMAP3K1 genes. Our group has observed that some SCC resistant to MAL-PDThave also an altered expression pattern of such genes. As a conclusion, we cansuggest that the MAPK pathway could be implicated in a decreased response toPDT. A combination of PDT with some other therapies that specifically targetgenes implicated in a decreased response to PDT could allow us to overcomethe resistance.

Resistance to photodynamic therapyin non-melanoma skin cancer

Ángeles JuarranzMadrid, Spain

Y. Gilaberte, S. González, E. Morel, A. Zamarrón

Key Words:Basal Cell Carcinoma, MAPK, Non Melanoma Skin Cancer, Resistance to PDT,

Squamous Cell Carcinoma

C3

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Clinical guidelines for the management of AK need to be regularly updated asnew treatments become available.

A systematic review of AK clinical guidelines was conducted. This informed thepreparation of a three-round Delphi panel followed by a consensus meeting,which combined opinions from 16 experts in 13 countries.

We found gaps in current guidelines with respect to new AK treatments such asingenol mebutate and daylight PDT. The Delphi panel established consensus sta-tements across diagnosis, definition, classification and management of AK. Whilethe diagnosis of AK essentially rests on the nature of lesions, treatment decisionsare based on several clinical and non-clinical patient factors and diverse envi-ronmental attributes. Participants agreed on distinguishing AK as three catego-ries: isolated AK lesions requiring lesion-directed treatment; multiple lesions ona small field; multiple lesions on a large field, both requiring specific treatmentapproaches. A treatment algorithm was developed which accounted for ap-proved treatments.

Structured expert consensus on AK:up-to-date treatment algorithm

Piergiacomo Calzavara-PintonBrescia, Italy

Key Words:PDT, methylaminolevulinate, AK 17

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Actinic keratoses are regarded as chronic skin disease in which numerous clini-cal and subclinical lesions typically co-exist across areas of sun-exposed skin.Individual lesions are always surrounded by a subclinical field and, therefore,serve as flag lesions. Evolution of AK into SCC has been regarded as a diseasecontinuum, so far. New data show that direct development of SCC without pre-cursor lesions can occur. Every individual lesion can become potentially invasiveand there is no way to clinically determine which lesions will transform into in-vasive squamous cell carcinoma, recur after treatment, and metastasise. Takinginto account that complete lesion clearance is rarely achieved in real-life practicethe basic treatment goal is to reduce the number of lesions and to achieve long-term disease control. A lesion directed treatment approach, however, can serveas helpful pre-treatment or additionally target those individual lesions refractoryto field treatment.

Field or lesion-treatment. What`s the best?Thomas Dirschka

Wuppertal, Germany

Key Words:AK, Field Cancerisation, Field-directed Treatment, Squamouscell Carcinoma

C5

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PDT is a highly effective treatment option for actinic keratosis (AK). As hyperke-ratosis of the AK impairs penetration of the photosensitizer and light a pretreat-ment is necessary.This retrospective study compares the effects of the recommended curettage(CUR), chemical keratolytic pretreatment with salicylic acid 10%(SA), and ureacream 40%(UR) on the efficacy and tolerability of PDT.

A total of 44 subjects with multiple AKs in face and scalp were analysed. In 15patients, CUR was performed prior to PDT while 15 and 14 patients underwentkeratolytic pretreatment with SA and UR, respectively, one day prior to PDT. Allpatients underwent one session of MAL-PDT using a 630-nm LED lamp at37J/cm2.Mean lesion response rates were 68.5%, 61.4% and 60.8% for CUR, SA and URrespectively. Differences were not significant. Patients with SA or UR experiencedsignificantly more pain than patients with curettage (6.3, 6.1 vs. 4.4). The cos-metic result and the patients' satisfaction 4 weeks after PDT were good to excel-lent in all three groups. However, pretreatment with SA or UR led to pronouncedlocal reactions compared to CUR.

CONCLUSION: Keratolytic therapy with SA or UR is an effective pretreatment forPDT. However, it leads to an increase in pain during PDT and pronounced localreactions.

The impact of keratolytic or physicalpretreatment on PDT

Patrick GholamHeidelberg, Germany

C. Fink, I. Bosselmann, A. Enk

Key Words:AK, curettage, PDT, pretreatment, salicylic acid, urea 19

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Pretreatment of the skin is essential for adequate penetration of topical photo-sensitizing agents and subsequent protoporphyrin IX (PpIX) accumulation. Weaimed to compare the potential of different physical pretreatments to enhancePpIX fluorescence in photodynamic therapy (PDT). Healthy volunteers were eachexposed to standardized skin preparation with curettage (CU), microdermabra-sion (MD) with abrasive pads, microneedling (MN) with dermarollers, ablativefractional laser (AFXL) and non-ablative fractional laser (NAFXL), followed by 3hours of methyl-aminolevulinate (MAL) (Metvix) incubation and subsequentred light illumination. Histology confirmed standardization of interventions. Datawill be shown on PpIX fluorescence accumulation, photobleaching and localskin reactions.

Physical pretreatment regimens to enhancePpIX uptake and PDT reactions in normal skin

Merete HaedersdalCopenhagen, Denmark

C. Bay, C.M. Lerche, B. Ferrick, P.A. Philipsen, K. Togsverd-Bo

Key Words:PpIX formation, Fractional lasers, Microneedling, Curettage, Abrasion

C7

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Introduction: DL-PDT has been shown to be as effective as and less painful thanconventional PDT in the therapy of actinic keratosis. Several differentpre-treatment regimens have been reported to increase the efficacy of DL-PDTby improving intraepidermal penetration of the photosensitizer. One of thesepre-treatment options is microneedling of the skin directly after application ofthe sensitizer.

Methods: Case series (n=2) from our private dermatological clinic.Patients were asked to apply a chemical sunscreen (SPF 50+) in the morningat home or at the latest 20 minutes before coming into our office. In our office,the photosensitizer was applied covering the actinic keratosis, directly followedby microneedling with a 0.5mm needler. Patients were instructed to expose thetreatment area to daylight for 2 hours, then to remove the sensitizer and to stayindoors. Patients were followed-up in our office during the healing period aswell as after 6 weeks after treatment for evaluation of therapy efficacy.

Results: We present patients who were treated with microneedling-assistedDL-PDT for actinic keratosis. Patients reported an uncomfortable temporary burningsensation while needling the skin after application of the sensitizer and showeda severe phototoxic reaction after the daylight sun exposure. High percentage ofactinic keratosis cleared after the intervention, mottled pigmentation faded withtime and the skin structure improved. Patients were very satisfied with the resultsand willing to undergo further treatment cycles with DL-PDT if necessary.

Discussion: In our experience microneedling-assisted DL-PDT is a highly effectiveand well tolerated treatment option in actinic keratosis including an aesthetic im-provement of the skin structure especially in sun damaged skin. As the procedureof needling is uncomfortable and the subsequent phototoxic reaction may bevery severe detailed patient education and post-treatment surveillance isrequired to obtain best treatment results and satisfied patients.

Microneedling-assisted DL-PDTfor Treatment of AK

Martina HundBerlin, Germany

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Recently different strategies have been used to improve the efficacy or reduce theadverse effects of conventional or standard photodynamic therapy (PDT). A verysuccesfull approach is the promotion of the uptake of 5-aminolevulinic acid (5-ALA) or methyl aminolevulinate (MAL) to increase the bioavailability of the pho-tosensitizers. Here, we demonstrate in a novel in vitro human full-thickness3D-skin equivalent of actinic field cancerization that pre-treatment with ablativefractional lasers (AFXL) followed by application of MAL results in singificantly in-creased levels of protoporphyrin IX (PPIX) and cytotoxicity in dysplastic epithe-lial cells after irradiation with 632 nm red light-emitting diode (LED) lamps. Resultswere evaluated using the Mann-Whitney U test. In vivo proof-of-principle analysesdemonstrate increased levels of PPIX and stronger inflammatory reactions forAFXL- and micro-needling-assisted MAL-PDT as compared to conventional PDT.Herein, application of MAL followed by micro-needling is more efficiant as com-pared to micro-needling followed by MAL.

Multi-modal therapy approaches in PDTPeter Arne Gerber

Duesseldorf, Germany

S. A. Braun, J.-M. Baron

Key Words:Laser, Needling, Assisted drug delivery, 3D skin organ culture, Power pdt

C9

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Topical PDT shows high efficacy rates for actinic keratosis (AK) of the face, ho-wever lower rates are seen for AKs of the scalp. Calcipotriol combined with PDTenhances PPIX fluorescence in animal models raising clinical perspectives in fieldcancerization. A randomized split-scalp pilot study was conducted and 5 pa-tients were enrolled with multiple Aks to receive conventional MAL-PDT in oneside vs Calcipotriol –MAL-PDT on the other. Clinical and histological data wereperformed. AK reduction ( lesion base) was 89,3% and 77,6% for Calcipotriol-PDT and Conventional MAL-PDT respectively. More adverse events were also seenin the CAL-PDT side. On histology, both sides improved the grades of atypia ofkeratinocytes. Considering several limitations, CAL-MAL-PDT combination maylead to enhanced therapeutic efficacy of « difficult-to treat « Aks.

Potential impact of patient vitamin D statusin AK response to MAL-PDT

Luis TorezanSao Paulo, Brazil

B. Grinblat, N. Valente, R.M. Szeimies, M. Haedersdal

Key Words:Calcipotriol, MAL, PDT, AK 23

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PDT with methyl aminolevulinate (MAL-PDT) and topical treatment with ingenolmebutate gel (IMB) are approved therapeutic options for patients withmultiple actinic keratoses (AKs). We performed a comparative, intra-patient,side-to-side, randomized clinical trial to compare treatment outcomes ofMAL-PDT and IMB.

Two symmetrical contralateral areas of about 25 cm2 harboring a similar (≥4)number of AKs were selected and randomly assigned to be treated with IMBfor 3 days or one session of MAL-PDT. Forty patients with a total of 404 AKs wereenrolled. The lesion complete response (CR) rates at 3 months were 61.8 % withIMB and 66.4 % with MAL-PDT (p=NS). Pain was higher with PDT but local skinreaction was more severe and time to healing was longer with IMB.

The cosmetic outcome was rated as good or excellent in all treated patients withboth drugs.

Ingenol Mebutate versus cMAL-PDT:an intrapatient side to side comparative study

Mariateresa RossiBrescia, Italy

C. Zane, M. Arisi, P. Calzavara-Pinton

Key Words:AK, Ingenol mebutate, MAL, PDT

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Background: It is assumed that thick actinic keratoses (AK) are more dysplasticthan thin lesions. However, this correlation has never been demonstrated. We in-vestigated if measured thickness of AK correlates with dysplasia.

Methods: Sixty-six AKs were examined. Prior to performing a punch biopsy, thethickness of each AK was measured using scale bars with thickness of 0.5 mm and1 mm. Subsequently, the thickness of the stratum corneum and the degree ofdysplasia were assessed histologically. Data were analyzed with Spearman’s test.

Results: The histological thickness of the stratum corneum increased significantlywith measured AK thickness (p=3·10-10). However, neither measured thickness(p=0.69) nor histological thickness of the stratum corneum (p=0.10) was corre-lated to the degree of dysplasia.

Conclusion: Thin AKs show the same severity of dysplasia as thicker lesions. Ourfindings suggest that all AK lesions independent of thickness must be treated.

Histologic AK dysplasia has no relationto AK thickness - consequences for treatment

Ida M. HeerfordtCopenhagen, Denmark

C.V. Nissen, T. Poulsen, P.A. Philipsen, H.C. Wulf

Key Words:AK dysplasia, AK thickness 25

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BackgroundTreatment efficacy for photodynamic therapy (PDT) is reduced when treating ac-tinic keratosis (AK) on the extremities in comparison to the face and scalp. We in-vestigated if sequential treatment with 5-fluorouracil cream (5-FU) anddaylight-PDT would enhance treatment response of AKs on the hands.

MethodsNineteen patients with multiple AKs on the dorsal aspects of both hands weretreated with methyl aminolevulinate (MAL) daylight-PDT. One hand was randomlyallocated to 7 days of pretreatment with 5% 5-FU cream twice daily before day-light-PDT, while the other hand was not pretreated. Treatment efficacy was eva-luated after 3 months. Data were analysed using the Wilcoxon test.

ResultsWe treated 654 AKs (grade I: 197, grade II: 352, grade III: 105). The overall clea-rance rate was significantly higher for 5-FU/daylight-PDT than for daylight-PDT(58% vs 46%, P=0.0001).

ConclusionCombining 5-FU and daylight-PDT is an effective way to enhance treatment effi-cacy of AKs on the hands.

One week of 5-FU followed by daylight-PDTof actinic keratosis: a combination study

Christoffer NissenCopenhagen, Denmark

S.R. Wiegell, I.M. Heerfordt, C.S. Mikkelsen, H.C. Wulf

Key Words:5-Fluorouracil, AK, Daylight-PDT, PDT, Pretreatment

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Actinic keratosis (AK) is a pre-cancerous condition characterised by patches ofthick, scaly or crusty skin developing on sun-exposed areas of the body. Whenmultiple AKs develop on a severely photodamaged skin, commonly used treat-ments include photodynamic therapy and diclofenac plus hyaluronic acid gel(DHA). Methyl aminolevulinate daylight photodynamic therapy (MAL DL-PDT) isan alternative to conventional photodynamic therapy (MAL c-PDT). Trials indica-ted that MAL DL-PDT is as effective as MAL c-PDT but reduces treatment-relatedpain and dermatological side effects. This analysis aimed to indirectly compareMAL DL-PDT to DHA. A total of three randomised trials were collected using a sys-tematic literature review. An adjusted indirect comparison was conducted oncomplete lesion response rate at 12 weeks. Results indicated that mild lesions,moderate lesions and mild & moderate lesions treated with MAL DL-PDT weremore than four times more likely to have a complete response than lesions trea-ted with DHA.

Bucher’s indirect comparison of DL-PDT withMAL cream versus diclofenac plus hyaluronicacid gel for the treatment of multiple AK

Rolf-Markus SzeimiesRecklinghausen, Germany

P.G. Calzavara-Pinton, C. Zane, M. Pacou

Key Words:AK, indirect comparison, MAL, PDT, Diclofenac plus hyaluronic acid gel 27

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Objective of the study was to assess the 12-month efficacy and safety of DL-PDTversus c-PDT in the treatment of face/scalp AKs in 34 patients from a previousintra-individual trial. Recurrence rate and clearance rate were assessed 12 monthsafter a single PDT session. The 12-month recurrence rate of AKs cleared at 3months was 13% after DL-PDT and 10% after c-PDT, with no statistical difference(p=0.16). For AK I, recurrence rate was 8% after c-PDT and 11% after DL-PDT(p=0.21). The 12-month clearance rate of baseline AKs was higher for c-PDT(76%) than DL-PDT (66%) (p<0.01). For AK I, 80% of baseline lesions was clearat 12 months after c-PDT and 71% after DL-PDT (p=0.01). Efficacy outcomes ofthe two treatments were similar for scalp AK while c-PDT was superior to DL-PDTfor face AK. There were no safety concerns during follow-up.

MAL DL-PDT is effective and safe in the long-term for the treatment of AKs of theface and scalp.

DL-PDT for AK:high maintenance of clearance at one year

Maria Concetta FargnoliL’Aquila, Italy

A. Piccioni, L. Neri, S. Tambone, C. Pellegrini, K. Peris

Key Words:DL-PDT, Long term efficacy, AK, Methyl aminilevulinate, conventional PDT

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Objective: Evaluate the histological impact of Daylight-PDT in the treatment ofActinic Keratosis (AK) and Field Cancerization.

Materials and Methods: Seventeen patients with multiple AK on the face weretreated with Daylight-PDT. They were submitted to skin biopsies in two differentareas (AK lesion and Field Cancerization region) before and 02 months after treat-ment.Two histological parameters of keratinocytes atypia were analyzed: intensity(mild, moderate or intense) and extension (1/3 to 3/3 of epidermis).

Results:• AK: 14 patients (82%) showed decrease of atypia intensity (p=0,016) and in 08patients (47%) the atypia extension reduced after treatment (p=0,046)

• Field cancerization: 06 patients (35%) presented atypia reduction (p=0,262)and 09 patients (52%) had improvement of the atypia extension (p=0,323)

Statistical method: McNemar test

Conclusions: Most of the AK (lesion base) improved with treatment.The histological improvement in the Field Cancerization was lower when com-pared to the AK lesions and not statistically significant.

DL-PDT for AK:histologic assessment of efficacy

Beni GrinblatSao Paulo, Brazil

C.F. Neto, N. Sakai Valente, R.-M. Szeimies, L.A. Ribeiro Torezan

Key Words:DL-pdt, AK, Field cancerization 29

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Background: AK is the most common non melanoma skin cancers and reflect anabnormal multistep skin cell development, due to the chronic UV-exposure. Noideal treatment exists, but the potential risk of their development to a moreinvasive form, requests a prompt treatment. DL-PDT with MAL, (Metvix® ;Galderma Laboratories, Paris, France) is an innovative treatment for AK.

Material and methods: Patients allocated to our PDT unit, affected by multipleactinic keratosis on sun exposed areas treated with DL-PDT were evaluated atbaseline and every three months, with Anthera 3D, Miravex© camera.

Results: In this retrospective study, 331 patients (56.7%male, 43.3% female) weretreated with DL-PDT. A full clearance in more than 2/3 of patients was observed,with one or two treatments. Different responses depended on the number oflesions and their severity ; for patients with 1-3 lesions (KIN I-II) a full clearancewas reached in 85% of cases.Anthera-3D images showed hemoglobinconcentration, pigmentation, and tone improvement in 310 patients.Conclusion: DL-PDT appears as an effective, safe and well-tolerated treatmentwith good cosmetic outcomes.

Retrospective analysis of DL-PDT and cPDTin AK with 3D imaging

Carmen CantisaniRome, Italy

F. Cantoresi, G. Paolino, M. Scarno, T. Gobello, S. Calvieri

Key Words:AK, DL mediated PDT, Early diagnosis, Methylaminolevulinate

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Daylight-mediated photodynamic therapy (DL-PDT) is an effective therapy foractinic keratoses (AK) and this presentation interprets European guidelines on itsdelivery using topical methyl aminolaevulinate (MAL). DL-PDT is suitable forpatients with grade I or II AKs or actinic field damage on face/scalp. Treatmentcan be performed most conditions, providing the temperature is suitable for thepatient to stay comfortably outdoors for 2 hours. Although feasible all year incertain southern locations, ability to perform DL-PDT effectively is more limited athigher latitudes. A SPF > 20 sunscreen should be applied to all sun-exposedareas usually 15 minutes before skin preparation. MAL cream is then applied,without need for occlusion, with daylight exposure to follow within 30 minutes.After 2 hours daylight exposure MAL cream should be washed off and thetreated area protected from the sun for the rest of the day.

Practical approach to the use of DL-PDTwith topical methyl aminolevulinate for AK:

a European consensusColin Morton

Stirling, Scotland

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DL-PDT is more and more used as first line treatment for facial AK. The aim of thepresent study was to compare the efficacy and tolerance of D-PDT to a standartBlue light PDT.

26 patients harbouring grade I to II AK were randomly assigned to receive D-PDTon one side of the face and scalp and blue light PDT on the other side. Daylightintensity was recorded with a portable device.

The mean number of AK was 23,1 on the C-PDT side versus 22 ,6 on the D-PDTside. The response rate at one month was 93% for C-PDT vs 89% for D-PDT. Atthree months the response rate was 96,6% vs 90% (p=0,18) and at six months94% vs 91% (NS).

At six months the mean number of new AK was 1,3 for C-PDT vs 2 for D-PDTPain evaluation by analogic scale was 7 for blue light and 2 for Daylight PDT(p=0,0077).

The present study confirms that D-PDT is equivalent to C-PDT for the cure rate ofgrade I and II AK. The great advantage of daylight-PDT is the considerable de-crease of pain.

Split face comparison of Daylight versusBlue light-PDT for the treatment of facial AK

Christophe BedaneLimoges, France

S. Assikar, S. Leobon, I.O. Matei, N. Souyri, A. Couraud

Key Words:PDT, AK , DL-PDT

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BackgroundConventional photodynamic therapy (c-PDT) is a widely used for treatment acti-nic keratosis (AK). Daylight photodynamic therapy (DL-PDT) has been shown tobe similar to c-PDT in the treatment of AK, better tolerated and nearly painlesswith high patient satisfaction. Compared with topical treatments for AK, DL-PDTis more time consuming for dermatologists, which could be a drawback to pres-cribe it in clinical practice.

AimEvaluate the average time spent by the dermatologist to prepare a patient for DL-PDT.

Material and methodsAn observational prospective including all the patients diagnosed with AK in theUnits of Dermatology of San Jorge Hospital and Jaca Hospital (Spain) from Fe-bruary to June 2015. Time spent for curettage and application of MAL was col-lected in minutes.

ResultsFifty patients were included in the study. The mean of the time was approxima-tely 6 minutes (range 3-10 minutes). The most common treated areas were face(n=38, 76%) followed by scalp (n=32, 64%). The average time in both locationswas five minutes, with a range of 3-7 minutes and 3-8 minutes, respectively.

ConclusionsDL-PDT is a simple procedure for the treatment field cancerization and AK, thatcan be easily performed in routine clinical practice.

DL-PDT can be administeredwithin the usual consultation duration

Ana Julia García-MalinisHuesca, Spain

A.J. García-Malinis, O. Callen García, P. Frías, Y. Gilaberte

Key Words:AK, Conventional PDT, DL-PDT, Field cancerization, Time 33

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• Make an appointment for the treatment:- Curettage- Cream application

• Choose an ad hoc schedule depending on the month, the geographicalposition of the place

• Prescription:- Uréa cream 30%: 1 application in the evening during one week, to startone week before the appointment- MAL cream- Actinica lotion- Don’t forget to bring a cap or a hat

• The D day: Two possibilities- Sunny day or no risk of rain:cream application by the doctor:

• Actinica application on all the face, the scalp, the hands• Curettage : very smooth thanks to the urea cream• Metvixia application with one finger- Rainy day: Treatment impossible today

• Curettage : very smooth thanks to the urea cream• Explanations to the patient (or third person) how to apply Actinica firstand Metvixia after:

• Topography• Quantity of both products• When to follow the treatment?• Application of Metvixia the first non rainy day within the next week• Then exposure to daylight within 30mn after the application of Metvixiago outside and stay there for 2 hours- What happens after treatment?

• Your skin will be red during one or two days and then scaly for 10 days• Be careful with the sun on the following day• Make an appointment within 3 months

DL-PDT: handling a safe and simple protocolJacques SavaryParis, France

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Daylight PDT has been shown to be as effective and better tolerated thanconventional PDT for actinic keratosis (AK) on the face and scalp. We have threeyears’ experience (2013-2015) of daylight PDT in Dundee, in the northeast ofScotland, having treated 64 patients over this period. Our data are encouragingwith treatment being very well tolerated (median pain score 1 (range 0-8)), withmost (73%) patients obtaining moderate to complete clearance. These data areencouraging as most of these patients had failed or been unable to tolerate otherconventional therapies, including topical agents and conventional PDT, and mosthad extensive moderate/mild AK requiring large areas of treatment. We have hada positive experience of daylight PDT and see this as a highly effective, welltolerated and efficient way to streamline PDT services and to offer an excellenttreatment option to patients closer to home.

DL-PDT experience in DundeeSally IbbotsonDundee, UK

Key Words:AK, Daylight, Efficacy, Pain, PDT, UK 35

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IntroductionDL-PDT is a new alternative method for KA treatment and field cancerization.The aim of this observation is to evaluate the number of patients eligible for thistreatment.

Material and methodsBetween March and October 2015: 110 patients treated by DL-PDT versus 320 byC-PDT.

DiscussionC-PDt is refunded in Belgium only in hospital, Metvix® being issued by the hos-pital pharmacy.Our medical center pratice c-PDT for 12 years.Working place is in countryside south of Brussels, where patients access DL-PDTeasily.Organization requires flexibity: when bad weather, patients can postpone treat-ment, or switch to C-PDT.For being effective, treatment requires strict respect of the procedure, requiringto explain carefully and educate the patient.

ConclusionDL-PDT is an interisting alternative to c-PDT even in Belgium• less time, less painful• lower cost (less cream, different coding than c-PDT)• enpower the patient.

DL-PDT: One year experience in Belgium:How to organize the pratice

to optimize treatmentMuriel Creusot

Genappe, Belgium

Key Words:C-PDT, DL-PDT, Field cancerization, Flexibility, KA-Organization

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Sassuolo is a small town located in Northern Italy with a population of ap-proximately 40000 inhabitants. Sassuolo hospital is equally small, however,since 2009, it has enjoyed a dedicated Dermatology Department providinggeneral dermatological care but with a special interest in DermatologicalSurgery and Dermato-Oncology. In order to supplement its therapeutic offerfor oncology patients, our Department has been performing "classic" PDT for3 years by now. So far, we have treated over 500 patients per year with clearancerates at 3 months for AKs, superficial BCCs and Bowen diseases equal to90%, 95% and 90% respectively.

Recently, our Department has been selected as the only DermatologyDepartment in our region, Emilia-Romagna, to participate in the SESAMEstudy focused on Daylight PDT; for this purpose, we are currently organizinga special area outside our hospital which will be specifically dedicated toDaylight PDT sessions.

PDT in Sassuolo, Modena:present practice and future plans

Marco CurciSassuolo, Italy

Key Words:AK, BCC, Bowen, Daylight, PDT, Sassuolo, Sesame 37

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Background: DL-PDT has been adopted as a convenient, painless way ofperforming PDT. However, the use is limited due to rainy or cold weather, and anindoor illumination source is needed which can act as a substitute for daylight.

Material: We investigated the use of the following lamp types: slide projector,overhead projector, white LED, red LED panel, Aktilite, and natural daylight in agreenhouse.

Method: The PpIX weighted fluence rate was calculated for all lamps. The fluencerate to prevent any build-up of PpIX in test persons during 2 hours of illuminationwas determined.

Results: Generally, 5000 lux was sufficient for complete activation of PpIX, exceptfor white LED that needed 12.000 lux to be as efficient. In the greenhouse therewill practically always be sufficient daylight, and the glass prevents sunburn.

Conclusion: Most lamps may be used although the efficacy will depend on thespectral distribution.

Can DL-PDT work indoors ?Hans Christian WulfCopenhagen, Denmark

I.M. Heerfordt, J. Heydenreich, C.M. Lerche

Key Words:DL-PDT, Fluence rate, Greenhouse, Lamp spectra, PpIX.

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Daylight PDT (DL-PDT) is a novel PDT modality in which the activation of thetopical photosensitizer is induced by the exposure to natural daylight instead ofartificial light sources without requiring preliminary occlusion. An ever-increasingbody of evidence supports the effectiveness and tolerability of DL-PDT withMAL for the treatment of actinic keratoses, highlighting that this approach can beconsidered an effective, safe and convenient alternative for the treatment offacial/scalp lesions, especially for the thin lesions. These findings were corrobo-rated by the results of two Phase III studies in Australia and Europe.

Overall, the procedure is perceived as less painful by the patients. Morover,larger areas of sun damage can be treated on a single occasion.

In Italy, DL-PDT has been recently approved for the treatment of actinic keratosis.We will report on our experience both in a private and in a University setting. Wewill also try to give some suggestion on off label use of DL-PDT (namely in thetreatment of actinic cheilitis, flat warts, sebopsoriasis).

DL-PDT experience in PadovaStefano Piaserico

Padova, Italy

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Coal tar, soot and polycyclic aromatic hydrocarbons are listed in the InternationalAgency for Research on Cancer Group I list, indicating them being acknowledgedas “Carcinogenic to humans” since decades. In 2009, UVR was added to thisGroup I list of the most established carcinogens. According to the EuropeanCAREX (CARcinogen EXposure) database, established with support from theEurope Against Cancer Programme of the European Union, within the EU at least9.1 million workers are regularly exposed to solar radiation during at least 75% oftheir working time. There is sound evidence that workers at various workplacesacross Europe, being exposed to intense levels of UVR, develop a much higherincidence of non-melanoma skin cancer. Thus, the development of skin cancerscreening algorithms for outdoor-workers, raising awareness for the impact ofnatural UVR on the induction and promotion of non-melanoma skin cancer inoutdoor workers by dissemination of information material on occupationalskin cancer to health care policy-makers, employers and outdoor workers aswell as the evaluation of impact of preventive measures such as suitable textilephoto-protection, appropriate sunscreens and sun-smart behaviour on thedevelopment of work-related skin cancer have to be considered.

Occupational skin cancer and preventionClaas Ulrich

Berlin, Germany

Key Words:Outdoor-workers, Skin cancer, Prevention

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Prevention of squamous cell carcinoma (SCC) in organ transplant recipients(OTRs) includes early treatment of actinic keratosis (AK). We investigated theeffect of repeated PDT for primary prophylaxis of skin dysplasia. These datarepresent an interim analysis of an on-going randomized controlled trial. Renaltransplant recipients (n:25) with normal skin were randomized to split-side PDTof the face, forearm and hand, the contralateral side serving as untreated control.Patients received PDT on inclusion and at 6-monthly intervals for 5 years.

We found that prophylactic PDT significantly delayed onset of AK compared withuntreated skin, p=0.020. At 3-years follow-up, 63% of patients had AKs inuntreated skin areas compared with 28% of patients in PDT-treated skin, with atotal number of cumulated AKs in untreated skin (n=43) compared with PDT-treated skin (n=8), p=0.005. These preliminary data indicate a novel approachto early prevention of AKs in OTRs.

Primary prevention of skin dysplasiain renal transplant recipients with PDT:

A randomized controlled trialKatrine Togsverd-BoCopenhagen, Denmark

S. Haukali Omland, H.C. Wulf, S. Schwartz Sørensen, M. Hædersdal

Key Words:Primary prevention, AK, Organ transplant recipients 41

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Background: Photodynamic therapy (PDT) is approved for selected nodular basalcell carcinomas (nBCC) but efficacy is reduced for large and thick tumours.

Methods: Patients with histologically verified high-risk nBCC (n=32) were includedand randomized to AFXL-PDT (n=16) or PDT (n=16). AFXL was applied at 5%density and 1000µm ablation depth. MAL was applied under occlusion for 3hours and illuminated with 633nm, 37J/cm2. Assessments were performed at 3,6, 9, 12 months, biopsies taken at 12 months.

Results: Clinical cure rates at 3 months were 100% (AFXL-PDT) and 88% (PDT,p=0.484). Histology at 12 months documented equal tumour clearance afterAFXL-PDT (63%) and PDT (56%). Cosmetic outcomes were highly satisfying afterboth treatments (p>0.090).

Conclusions: Long-term efficacy was similar after PDT and AFXL-PDT with a trendfor a favourable short-term cure rate after AFXL-PDT. AFXL-PDT needs further refi-nement for nBCC and at present is not recommended over PDT.

Fractional laser-mediated PDTof high-risk BCC-a randomized clinical trial

Uwe PaaschLeipzig, Germany

C.S. Haak, K. Togsverd-Bo, D. Thaysen-Petersen, H.C. Wulf, R.R. Anderson, M. Haedersdal

Key Words:BCC, High risk, Laser, Fractional, PDT

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Photodynamic therapy (PDT) is a well-established treatment for actinic keratosis(AK), basal-cell carcinomas (BCC), and Bowen´s disease (BD).

The results of a retrospective analysis of patients treated with methyl aminolevu-linate and red light PDT (MAL-PDT), over the past decade at the Hospital de Braga,Portugal, were statistically analysed on the basis of their clinical records.

More than 550 patients with mean age of 72 years were treated with MAL-PDT.Two thirds of these patients were female. In terms of diagnostics, 67% of thepatient population were affected with AK, 27% presented with BCC, and 4%had BD. With an average 5,5 year follow-up, 99.5% of the lesions were cleared.

This experience in a European excellence center of PDT, where this therapy isused routinely, showed the excellence of MAL-PDT for treating AK, BCC and BD,with minimal recurrence rate.

10 years of PDT experience for AK and BCCin PortugalCeleste BritoBraga, Portugal

Key Words:AK, BCC, Bowen´s disease, MAL-PDT, Statistical analysis 43

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The antimicrobial drug resistance threat has stimulated the search for novelantimicrobial therapies that overcome the limitations of currently-available drugs.Owing to its multi-site and multi-target mechanism of action, PDT is unlikely tosuffer from the same drawbacks as conventional drugs and should be consideredas an alternative and be given an opportunity to realise its full potential. In thispresentation, the state of the art in the development of antimicrobial photo-dynamic drugs will be reviewed and novel approaches will be presented andillustrated mainly with examples from our laboratory.

*This work was supported by a grant of the Spanish Ministry of Economy andCompetitiveness (CTQ2013-48767-C3-1-R).

New approaches to antimicrobial PDT*Santi Nonell

Barcelona, Spain

R. Ruiz-González, M. Agut

Key Words:Antimicrobial PDT, biological drugs, Drug resistance,

Genetically-encoded photosensitisers, Nanoplasmonics, Singlet oxygen

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Background: Onychomycosis do not have a good response to antifungals.

Objective: to investigate the efficacy and safety of methyl-aminolevulinate (MAL)photodynamic therapy (PDT) to treat onychomycosis.

Methods: A multicentre (3), randomized, placebo-controlled clinical trialcomparing 3 sessions of 40% urea plus conventional MAL-PDT with 40% ureaplus red light (pPDT) in onychomycosis was performed. Clinical (evaluated byOnychomycosis Severity Index (OSI)) and microbiological efficacy was blindlyevaluated after 36 weeks of follow-up.

Results: One center was withdrawn from the study (n=20), leaving 40 patients inthe trial. Twenty-two received MAL-PDT and 18 pPDT. Four patients (18.18%) inthe former and 1 (5.56%) in the later were clinically cured (NTT 7.92, CI95% 2.98,-9.69, p=0.23). Non-dystrophic onychomycosis showed better clinical response(OSI>75% 53,85% vs 18,75% (p =0,048) and microbiological cure (41.56% vs7.14%,(p=0.037)) with MAL-PDT than those dystrophic. No significant sideeffects were reported.

Limitations: the reduction of the sample size; efficacy in the control group couldbe attributed to application of 40% urea.

Conclusion: this study did not show statistically significant differences betweenurea 40%-MAL-PDT and urea 40% plus red light for onychomycosis. However, inabsence of total nail dystrophy, PDT was significantly better than placebo.

MAL-PDT for onychomycosis: A multicenter,randomized, controlled, clinical trial

Yolanda GilaberteHuesca, Spain

P. Robres, MP. Frías, J. Vera-Alvarez, I. García-Dóval, A. Rezusta, C. Aspiroz

Key Words:Onychomycosis, PDT, Clinical trial, Methyl-aminolevulinate 45

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Conventional PDT (c-PDT) is a widely used and approved non-invasive treatmentfor actinic keratosis (AK). However, pain and the need for special light sourceequipment are limiting factors for its use, especially in the treatment of large areas.Daylight PDT (DL-PDT) has subsequently shown similar efficacy to c-PDT in thetreatment of AK. It is nearly painless and more convenient to perform.

Recently, recommendations for the use of MAL DL-PDT in patients with large-scalephotodamaged skin were developed by an international expert group, and theconcept of 'actinic field damage' which refers to photodamage associated withactinic epidermal dysplasia was elaborated (J Eur Acad Dermatol Venereol. 2016Jan;30(1):8-15).

It was found that DL-PDT is not only efficacious but also nearly pain-free and easyto perform, and therefore results in high patient acceptance especially for thetreatment of areas of actinic field damage.

Daylight photodynamic therapy with MALcream for large-scale photodamaged skin

based on the concept of 'actinic field damagePeter BjerringVejle, Denmark

W.G. Philipp-Dormston, G. Sanclemente, L. Torezan, M. Tretti Clementoni, A. Le Pillouer-Prost,H. Cartier, R.M. Szeimies

Key Words:Actinic field damage, Daylight, Large-scale

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PDT is an effective treatment for actinic keratosis and non-melanoma skin cancer.It also has several non-oncologic off-label indications, such as improvement ofinflammatory diseases of the skin and virus-induced lesions. For those who usePDT, only for the approved treatment of actinic keratosis, most know thatpatients will comment on the cosmetic improvement in their skin quality afterthe procedure. These clinical findings have led to examination of PDT as anaesthetic indication.

Previous studies related to the aesthetic outcomes of PDT show the improvementof lentigines, sallow complexion, skin roughness and fine wrinkles. Histologically,it is possible to observe the decrease of elastotic material and expression of p53,together with induction of neocollagenasis, an effect of cytokine induction.Comparison between IPL PDT and IPL alone demonstrated that IPL PDT is moreeffective. Furthermore PDL-PDT was shown to induce collagen production. Morerecently researchers/physicians’ attention has been focused not only on how toactivate the photosensitizer but also on how to prepare the skin prior to itsapplication. Microneedling, fractional lasers and sand paper are the mostpopular ways to prepare the skin also for cosmetic purposes. Many of theseprocedures will be described and results evaluated.

Aesthetic indications for PDTMatteo Tretti Clementoni

Milan, Italy

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Recently the introduction of daylight-activated photodynamic therapy (DL-PDT)has advanced the concept of PDT. Various clinical studies have demonstratedthat DL-PDT with methyl aminolevulinate (MAL) is comparably effective asconventional or standard PDT (cPDT) but significantly less painful, markedly in-creasing the tolerability of PDT. Nevertheless, both, cPDT and DL-PDT, are asso-ciated with the development of post treatment erythema (less intense for DL-PDT)that may last for few days up to weeks. Reported strategies to prevent or reducepost treatment erythema include the application of sunscreen with an organic fil-ter (DL-PDT), light blocking silver paste (DL-PDT) or topical glucocorticosteroids.Here, we demonstrate that brimonidine tartrate 0.33% gel (BT), which was re-cently introduced for the management of facial erythema in patients with rosacea,has the potential to rapidly and significantly reduce DL-PDT-associated post treat-ment erythema. BT may furthermore increase the tolerability of DL-PDT.

Management of post-treatment erythemaPeter Arne Gerber

Duesseldorf, Germany

Key Words:Daylight-activated PDT, Post treatment erythema, Brimonidine tartrate

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Pain is a major side effect of PDT when using red light for irradiation. To optimizepain management during conventional PDT with methyl aminolaevulinate in menwith field cancerization on the scalp and forehead, the effect of either scalpnerve blocks, intravenous analgesia (piritramid 75 mg i.v. plus oral metamizole)in combination with cold-air analgesia and cold air analgesia alone was compa-red in a randomized controlled trial.

Maximum pain during PDT was significantly reduced in the group receiving scalpnerve blocks (VAS 2.1+1.3). No significant difference in the VAS-scale was foundbetween i.v. analgesia with cold air and cold air alone (7.3+1.1 resp. 8.4+2.0).Systolic blood pressure during the first 3 min of irradiation was significantly lowerin the group receiving scalp nerve blocks. Clinical and cosmetic results wereexcellent in all treatment groups.

This study shows the excellent pain alleviation of scalp nerve blocks duringlarge field PDT, while i.v. analgesia and cold air did not result in a considerablereduction of pain.

Scalp nerve blocks for pain managementduring large field PDT

Sigrid KarrerRegensburg, Germany

Key Words:AK, cold-air analgesia, Field cancerization, Intravenous analgesia, Scalp nerve block 49

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Actinic cheilitis (AC) is a premalignant condition, whose management can bedifficult. Ever-growing evidence suggested that PDT may be effective in AC,although pain is common and sometimes relevant. Daylight PDT (DL-PDT) is asimplified procedure that was found to be more tolerated than conventional PDTin patients with actinic keratosis.

Eight patients with refractory AC were treated with DL-PDT using methyl-amino-levulinate (MAL). Two sessions were performed with an interval of 7-14 days.Exposure to daylight occurred within 30 min fromMAL application and lasted for2 hours, in all weather conditions except rain, usually between 08:30 and11:00 a.m. A complete response was observed in 7 patients at 3 months andwas maintained over the post-treatment period in most patients. Tolerability wasgood in all subjects but one. Our preliminary results suggest that DL-PDT is aninteresting modality that can be considered for the treatment of AC.

DL-PDT with methyl-aminolevulinatein the treatment of actinic cheilitis

Dario FaiLecce, Italy

C. Fai

Key Words:Actinic cheilitis, DL-PDT, Methyl-aminolevulinate

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BackgroundCutaneous leishmaniasis (CL) is a vector-born disease with an incidence ap-proaching 2 mill new cases yearly. Photodynamic therapy is highly effective forCL, but requires equipment only available at specialized treatment centers.

ObjectivesThe objective of this single-center, open study was to establish proof-of-conceptfor the efficacy of DL-PDT in the treatment of CL using clinical, microbiological,and molecular clearance as outcome measures.

MethodsThirty-one patients with CL underwent DL-PDT. Fourteen patients were treated inthe hospital garden under professional supervision and 17 patients underwentDL-PDT as self-administered treatment modality at home. Treatment sessions wererepeated at weekly intervals until clinical and microbiological cure.

ResultsThe overall cure rate for hospital-based and self-administered DL-PDT was 88.9% (Intention-to-Treat cure rate 77.4%), for the hospital-based treatment groupalone 85.7%, and for self-administered treatment 92.3%.

ConclusionsDL-PDT proved to be effective in the treatment of CL caused by L. major and L.tropica.

Cutaneous leishmaniasis responds to DL-PDT:proof of concept for a novel self-administered

therapeutic modalityClaes D. Enk

Jerusalem, Israel

C. Jaffe, H.C. Wulf

Key Words:Cutaneous leishmaniasis, DL-PDT, Self-administered 51

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Photodynamic Therapy with methylaminolevulinate 80 mg/g demonstrates signifi-cant efficacy in acne.

Aims: To investigate efficacy and safety of methylaminolevulinate (MAL) at 80 mg/gvs vehicle cream followed by red light illumination in severe acne patients.

Methods: Multicenter, randomized, double-blind and vehicle controlled study. Atotal of 153 male and female patients aged 12 to 35 years were enrolled at 15 sitesin the US having Fitzpatrick skin type I through VI, 25 to 75 inflammatory and 20 to100 noninflammatory acne lesions, no more than 3 nodules on the face and an In-vestigator’s Global Assessment (IGA) score of 4. MAL or vehicle cream was appliedon the skin and left to incubate under occlusion for 1.5 hours before illuminationwith a light dose of 37 J/cm2 (red light with average wavelength of 632 nm) usinga lamp with a total of 512 light emitting diodes (LEDs) covering an area of approxi-mately 32 cm x 18 cm. All patients received 4 treatments 2 weeks apart (at weeks0, 2, 4 and 6). The primary endpoint was reduction of inflammatory lesions 6 weeksafter the last treatment (week 12). Secondary endpoints were proportion of pa-tients with success according to IGA (success defined as an improvement of atleast 2 grades from baseline), reduction in noninflammatory lesions, pain during il-lumination using a Visual Analogue Scale (VAS) from 0 to 10 and erythema score.

Results: Patients treated with MAL had a statistically significant reduction in inflam-matory lesions of 43.8% as compared to 26.6% in the vehicle group (p=0.003).MAL showed a statistically significant improved IGA treatment success rate com-pared to vehicle, 44.0% versus 26.4% (p=0.013). A comparable reduction in non-inflammatory lesions was achieved in both groups (p=0.853).Post treatment erythema was reported more frequently in the MAL group (89% ver-sus 70%), which generally subsided by the following day. Twelve patients with-drew from the study due to adverse events. Six (6%) patients in the MAL groupwithdrew due to pain related adverse events (pain, burning or stinging). No seriousadverse events were reported in the study.

Conclusions: MAL significantly decreased the number of inflammatory lesions andsignificantly improved IGA success rate. Comparable efficacy was demonstratedin reducing noninflammatory lesions and the treatment was well tolerated.

PDT for AcneAnn-Marie WennbergGothenburg, Sweden

Key Words:Acne,Inflammatory lesions, MAL, PDT

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POSTERS

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Background: Photodynamic therapy (PDT) using topical application of aminole-vulinic acid (ALA) is an effective treatment for acne vulgaris. However, there is noclear consensus on the treatment regime in Asians.

Aim: To determine the efficacy, safety and tolerability of 5%-ALA PDT in the treat-ment of truncal acne in Asians.

Methods: Patients with truncal acne were treated with 5%-ALA under occlusionfor 3 hours. All were treated with a red light source at wavelength 630 nm andan irradiance of 38mW/cm2 giving a total dose of 37 J/cm2. The numbers of acnelesions were recorded at baseline and regular intervals.

Results: Fifteen patients were recruited. Overall, there was a 64.2% reduction inthe inflammatory lesions count and a 24.3% reduction in the non-inflammatory le-sions count at the end of the 12 weeks follow-up. Both mean lesions counts weresignificantly lower than baseline at all follow-up time points with paired t tests (allp values <0.05).

Conclusion: A single treatment session of 5%-ALA PDT was effective for the treat-ment of truncal acne with little side effects and acceptable in our Asian patients.

PDT with topical 5% 5-aminolevulinic acid forthe treatment of truncal acne in Asian patients

Yik Weng YewSingapore

Y.C. Lai, Y.L. Lim, W.S. Chong, C.T. Theng

Key Words:8-hydroxy-2'-deoxyguanosine apoptosis, Cancer cell lines,

PDT, phthalocyanine, Reactive oxygen species

P1

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P2

Background: Photodynamic therapy (PDT) using daylight exposure is now usedto reduce pain related to conventional PDT with Methyl-aminolevulinate (MAL).Subjects are advised to protect the areas with sunscreen. This work investigatedthe effect of sunscreen on MAL penetration in ex vivo human skin.

Methods: Particle-free sunscreen (Actinica® Lotion SPF 50+) was applied beforeMetvix cream containing [14C]-MAL for 2.5 hours on excised human skin sam-ples mounted on diffusion cells. Penetration of [14C]-MAL was measured in thewhole skin and receptor liquid by liquid scintillation counting (penetration in thedifferent skin compartments has not been traced). Each condition was performedin triplicate on three different donors. Statistical analysis was performed usingtwo-way ANOVA test. A p value of less than 0.05 was considered as statisticallysignificant.

Results & conclusion: The mean absorbed dose of [14C]-MAL in all the treatmentgroups represented 0.002% and 0.05% to 0.06% of the applied dose inreceptor liquid and in total skin, respectively. Treatment with sunscreen had nostatistically significant effect on [14C]-MAL skin penetration. The results indicatethat Actinica® Lotion is unlikely to modify the Metvix safety and efficacy clinicalprofile.

Effect of sunscreen on Metvix absorptionin ex vivo human skin

Hanan Osman-PonchetBiot, France

K. Sevin, A. Gaborit, J. Hanaizi, G. Bouvier, O. Duffy-Roger, P. Comby, B. Ruty, D. Kerob

Key Words:Actinica® Lotion, MAL, PDT 55

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Background: Photodynamic therapy (PDT) using daylight exposure is now usedto reduce pain related to conventional PDT with Methyl-aminolevulinate (MAL).Subjects are advised to protect the areas with sunscreen. This work investigatedthe effect of Actinica® Lotion on PpIX photobleaching in ex vivo human skin.

Methods: Excised human skin samples were treated with PpIX solution for 1 hour.Due to its high molecular weight, PpIX penetration in epidermis was facilitated byusing microneedles. Skin samples were then treated with Actinica® Lotion (SPF50+) and exposed to solar simulator for 1 hour. PpIX concentrations in total skinwere measured by HPLC with fluorescence detection. Statistical analysis was per-formed using two-way ANOVA test. A p value of less than 0.05 was consideredas statistically significant.

Results & conclusion: Exposure to solar simulator induced a decrease of PpIXconcentration by 80% and 69% with and without Actinica treatment, respecti-vely. No statistically significant difference was observed between these two treat-ment groups. The results indicate that Actinica® Lotion is unlikely to modify theclinical efficacy profile of Metvix in daylight photodynamic therapy.

Effect of sunscreen on Protoporphyrin IXphotobleaching in ex vivo human skin

Hanan Osman-PonchetBiot, France

K. Sevin, A. Gaborit, G. Bouvier, P. Comby, O. Duffy-Roger, D. Kerob, B. Ruty,

Key Words:Actinica® Lotion, PDT, Photobleaching, PpIX

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Introduction: Numerous therapies have been used in the treatment of chondro-dermatitis nodularis helicis (CNCH). We review the patients diagnosed with CNCHand treated with PDT.

Material and methods: A retrospective observational study was performedincluding all patients diagnosed with CNCH and treated with PDT between 2008and 2015.Continuous variables were described using means and standard deviations (SD).Statistical analyses were carried out using SPSS software (version 20.0, Armonk,NY: IBM Corp).

Results: Forty tree patients were included in the study. Thirty two (74.4%)responded to PDT treatment with relieve of the pain and resolution of the noduleand the inflammation. The mean follow-up was 20 months. Ten patients (23.3%)experienced a recurrence of the lesions, with an average time of 24.9 months.

Discussion: This study presents the largest series of CNCH treated with MAL-PDTwith the longest follow-up. The results support that PDT is effective to treat CNCH.

Chondrodermatitis nodularis helicis:report of 43 patients treated with PDT

Ana Julia García-Malinis1Huesca, Spain

L.Turrión-Merino, B. Pérez-García, Y. Gilaberte, A. Harto-Castaño

Key Words:Chondrodermatitis nodularis helicis, Conventional PDT, MAL 57

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Actinic keratosis (AK) may be considered a form of “in situ squamous cellcarcinoma” of the skin.

However, at this moment it is not possible to predict which AK will progress toinvasive squamous cell carcinoma. Therefore it is essential that an adequatetreatment is considered for each patient.

The objective of this work is to summarize and describe the various treatmentoptions that are available to treat AK.

The treatment options based on the experience at the Hospital de Braga can bedivided in two groups: lesion-directed therapies (cryotherapy or curettage) andfield-directed therapies (including MAL-PDT and Daylight, diclofenac, imiquimod,ingenol mebutate or 5-fluorouracil).

Theses therapies have different indications depending on the number, gradeand distributions of the lesions and patient characteristics as skin type andimmunosuppression.

It was concluded that the treatment of AK should be personalised with possiblecombinations of treatments either simultaneously or sequentially.

AK: adjusting the therapy to the patientRui Pedro Santos

Baguim do Monte, Portugal

Key Words:AK, Combination, Field-directed, Lesion-directed, Personalised

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Introduction: Nevus sebaceous is an uncommon benign hamartoma of the skinusually present at birth that may experiment growth and thickening during pubertyand in some cases, malignant transformation. The aim of this study is to describethe clinical outcome of photodynamic therapy applied to sebaceous nevi af-fecting aesthetically concerning areas such as eyelids or the face.

Patients and methods: We treated 6 patients affected with nevus sebaceous withphotodynamic therapy using topical 20% ALA or MAL. Clinical improvement wasevaluated using photographs of the lesions taken in each session assessing anydecrease of its volume.

Results: All patients showed at least mild improvement of the lesions. Completedisappearance of the lesion was not achieved. There was no significant side ef-fects. No malignant neoplasm appeared during the follow-up.

Conclusions: PDT can be considered as an alternative therapeutic modality in pa-tients affected by sebaceous nevi when surgery has limitations.

Nevus sebaceous : PDT approachOscar Muñoz Moreno-Arrones

Madrid, Spain

B. Pérez García

Key Words:Children, Eyelid, Face, Nevus sebaceous, Non-invasive treatment, PDT 59

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Introduction: Kaposi sarcoma (KS) is a well described multifocal systemicdisease of vascular origin with a notable rise in its incidence in the last 30 yearsdue to its AIDS-related epidemic variant. Use of photodynamic therapy in KaposiSarcoma has been scarcely reported in literature with dissapointing results.

Matherial and Methods: patient 1: a 89 year-old man with multiple KS papules onthe lower extremities received two sessions of M-ALA cream (160 mg/g) at adosage of 37 J/cm2 through two months. Patient 2: a 37 year-old man with AIDSand disseminated papules and macules with predominance on neck and backsurface received 5 sessions of PDT with M-ALA cream (160mg/g) through fivemonths.

Results: patient 1 showed flattening of several papules of leg KS. Patient 2 wasrefractory to treatment with remaining diseminated papules.

Conclusion: We herein present two cases of KS with different response to PDT.

Kaposi Sarcoma treated with PDT.A report of two cases

Pablo Fonda-PascualMadrid, Spain

A. Harto-Castaño, B. Perez-Garcia

Key Words:HIV, Kaposi Sarcoma, MAL, Non-standard indications, Oncology, PDT

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Photodynamic therapy (PDT) is a safe treatment for actinic keratosis, Bowen'sdisease and superficial basal cell carcinoma. Superficial fractional laser systemscan be used to pretreat the skin instead of the usual mechanical procedure. Laserpretreatment accelerates topical absorption of the photo-sensitizing medicationand markedly reduces pain during light treatment.

Pretreatment with an AFXL (ablative fractional laser) accelerates absorption of thephoto-sensitizing drug. Despite equally strong local reactions, patients report(n=246) significantly less pain during light treatment (an average 3 instead of 8 ona 0 to 10 pain scale). AFXL also has a positive impact on the aesthetic aspect ofPDT. For many years, fractional laser has been used successfully in aesthetic der-matology to treat age-related changes of the skin (e.g. wrinkles, coarseness). AFXLand PDT complement each other perfectly.

PDT with laser pretreatment in fieldcancerisationBettina Rümmelein

Kilchberg, Switzerland

Key Words:Laser, Pain, PDT, AK, AFXL, Aesthetic 61

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Awards for best oraland poster presentations

� Awards for best posters

1st place: 500e2nd place: 300e3rd place: 200e

Sponsored by photonamic

� Awards for best oral presentations

1st place: 500e2nd place: 300e3rd place: 200e

Sponsored by Galderma International

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