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1 4 T H A N N U A L C O N G R E S S

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Friday, April 4th - Saturday, April 5th 2014Nice - France

www.euro-pdt.org

Program

THE EUROPEAN SOCIETY FORPHOTODYNAMIC THERAPY

Pho

to:B

.Gilli

Congress PresidentJ.P. Lacour, Nice, France

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

R.-M. Szeimies, Recklinghausen, Germany, Vice PresidentA. Sidoroff, Innsbruck, Austria, Board MemberC.A. Morton, Stirling, Scotland, Board Member

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

VenuePDT Training Course: Hôpital l'Archet 2151 Route Saint-Antoine de Ginestière, Nice

Tel: +33 (0)4 92 03 77 77

PDT Annual Congress: Hôtel Le Meridien1, Promenade des Anglais, Nice

Tel: +33 (0)4 97 03 44 44

Congress secretariat and hotel reservationVISTA

EURO-PDT 20149 rue Henri Martin - 92772 Boulogne Billancourt Cedex France

Tel: +33 (0)1 46 43 33 42Fax: +33 (0)1 46 24 88 38

Email: [email protected]

1

Prof. Lasse R. BraathenPresident of EURO-PDT

Welcome to the 14th Annual Congress of the EuropeanSociety for Photodynamic Therapy in Dermatology (PDT),theworld’s largest congressdevoted to researchandclinicaluse of PDT in dermatology.

PDT is a well established successful method for treatingnon-melanoma skin cancer. It is furthermore success-fully documented for other indications, for example:acne, skin rejuvenation, various skin infections, skin lym-phomas and other dermatological conditions.

As inpreviousyears, theEURO-PDTspeakersandparticipantsare clinicians and researchers working mainly in Europe,but the number of participants from other parts of theworld is steadily increasing.We are convinced the program will present exciting andcompelling newdevelopments to help you better diagnoseand treat your patients.In addition, the opportunity to discuss these newdevelopments and to exchange information with yourcolleagues is unlimited.

Welcome to Nice!Participate and profit

32

Dear Colleagues,

I am pleased to extend a warmwelcome to attendees fromEurope and around theworld to the 14th Annual Congress ofthe European Society for Photodynamic Therapy.

I am proud and happy to bring back this prestigiousCongress to the French Riviera after the 10th Congress inMonaco in March 2010.

This congress is designed to provide an opportunity forthose interested in PDT to learn about the latest researchand new developments and their potential application inclinical practice. The scientific programwill allowanupdateon PDT guidelines, new practical approaches and recentaspects in oncologic and non-oncologic indications.

Scientific Conferences are hosted by the Meridien Hotelconference centre, which is strategically situated on thewaterfront in the heart of Nice. Participants will enjoyviewsof theMediterranean SeaandPromenadedesAnglaisas theymove between their sessions. This centre iswithinwalking distance of a great variety of accommodation,dining, shopping, tourist attractions, and transportation.

Welcome to Nice!

54

Prof. Jean-Philippe LacourCongress President

PDT Training CourseUpdate on Photodynamic Therapy

Hôpital Archet 2 – University Hospital of NiceFriday, 04th April 2014

Conference room (Hôpital Archet 2, level -3)

and Department of Dermatology (Hôpital Archet 2, level -1)

07:45 Departure from hotel Le Méridien

08:30 Welcome and introduction level -3Lasse R. Braathen, Bern, Switzerland - Jean-Philippe Lacour, Nice, France

08:40 The basics of conventional and Daylight-PDT, “Gain without Pain“Lasse R. Braathen, Bern, Switzerland

09:00 New developments of ALA/MAL application and light sourcesRolf-Markus Szeimies, Recklinghausen, Germany

moving to level -1

09:20 Hands on demonstration of Daylight-PDTPreparation of lesions and subsequent daylight exposureJean-Philippe Lacour, Nice, France - Abdallah Khemis, Nice, France

back to level -3

10:30 Coffee break

10:50 Skin rejuvenation/esthetics with PDT: the evidenceRolf-Markus Szeimies, Recklinghausen, Germany

11:10 The field cancerisation concept and its implication for treatmentLasse R. Braathen, Bern, Switzerland

11:30 The latest European Guidelines on PDTColin A. Morton, Stirling, Scotland, UK

11:50 Patient demonstration during daylight exposureJean-Philippe Lacour, Nice, France

12:30 Course Certificate/Diploma hand-out and closingJean-Philippe Lacour, Nice, France - Lasse R. Braathen, Bern, SwitzerlandRolf-Markus Szeimies, Recklinghausen, Germany

12:45 Return to hotel Le Méridien

Course directors:J.P. Lacour, Nice, France

R.-M. Szeimies, Recklinghausen, GermanyL.R. Braathen, Bern, Switzerland

Faculty:J.P. Lacour, Nice, France

R.-M. Szeimies, Recklinghausen, GermanyC.A. Morton, Stirling, ScotlandL.R. Braathen, Bern, Switzerland

A. Khemis, Nice, FranceDepartment of Dermatology, Nice

76

16:05 Plenary Session II: Daylight PDT - accumulationof evidence and experienceColin Morton / Ann-Marie Wennberg

16:05 Results of 2 randomised, controlled, phase III studies withDaylight-PDT in Australia and Europe .....................................................C8Jean-Philippe Lacour, Nice, France

16:15 Fx Laser + Daylight-PDT vs Daylight-PDT vs c-PDTvs laser alone in OTR ..................................................................................C9Katrine Togsverd-Bo, Copenhagen, Denmark

16:25 Clinical experience of Daylight-PDT in Spain .....................................C10Lidia Comba Pérez-Pérez, Vigo, Spain

16:35 Clinical experience of Daylight-PDT in UK ..........................................C11Sally Ibbotson, Dundee, Scotland, UK

16:45 Clinical experience of Daylight-PDT in Switzerland ..........................C12Lasse R. Braathen, Bern, Switzerland

16:55 Clinical experience of Daylight-PDT in Canada ..................................C13Lori Ingriselli, Sudbury, Canada

17:05 How simple can it be? The art of omittance ......................................C14Alexis Sidoroff, Innsbruck, Austria

17:15 Discussion, all presenters

17:25 Plenary Session III:Lesion-directed PDT for AK & NMSCRolf-Markus Szeimies / Alexis Sidoroff

17:25 Patch-PDT: routine use in an office-based setting ...........................C15Holger Petering, Hildesheim, Germany

17:35 Optimized light sources for Patch-PDT ................................................C16Helger Stege, Detmold, Germany

17:45 Patch-PDT: convenient and effective for actinic cheilitis? .............C17Sonja Radakovic, Vienna, Austria

17:50 Patch-PDT for intraepithelial SCC..........................................................C18Swantje Ehrig, Recklinghausen, Germany


18:05 End of Session

20:30 Cocktail reception and Congress Dinner

14TH Annual CongressHotel Le Méridien, NiceFriday, 04th April 2014

9

11:00 Registration opens

12:30 Lunch

14:00 Welcome Address - President EURO-PDTLasse R. Braathen, Bern, Switzerland

14:10 Welcome Address - Local Congress PresidentJean-Philippe Lacour, Nice, France

14:15 Plenary Session I: Practical ways to improve efficacy& tolerability of PDTLasse R. Braathen / Jean-Philippe Lacour

14:15 Current guidelines for PDT ........................................................................C1Colin A. Morton, Stirling, Scotland, UK

14:25 Influence of pre-treatment with urea cream 40% on faceand scalp AK on efficacy and tolerability ..............................................C2Patrick Gholam, Heidelberg, Germany

14:35 PDT in acne: where do we stand, what's the future .............................C3Brigitte Dreno, Nantes, France

14:45 Pretreatment with calcipotriol enhances MAL-induced PpIXformation. A murine study ........................................................................C4Christiane Bay, Copenhagen, Denmark

14:55 A promising new way to reduce inflammation in PDT withoutreducing efficacy .........................................................................................C5Hans Christian Wulf, Copenhagen, Denmark

15:05 A new approach to a gentle PDT treatment ...........................................C6Stine Regin Wiegell, Copenhagen, Denmark

15:15 New light sources (textiles) - First results of a study........................C7Serge Mordon, Loos, France


15:35 Coffee Break and Poster Viewing

14TH Annual CongressHotel Le Méridien, NiceFriday, 04th April 2014

8

10:20 Cryotherapy is preferable to ablative CO2 laser for the treatmentof isolated actinic keratoses of the face and scalp:a randomised clinical trial ....................................................................C30Christina Zane, Brescia, Italy


10:45 Coffee Break and Poster Viewing

11:15 Plenary Session VI: PDT and PhotochemorejuvenationRianne M.J.P. Gerritsen / Yolanda Gilaberte

11:15 PDT for skin rejuvenation: German consensus on practical aspects ...C31Rolf-Markus Szeimies, Recklinghausen, Germany

11:25 Conventional MAL-PDT with microneedling on actinicallydamaged skin ...........................................................................................C32Luis Torezan, Sao Paulo, Brazil

11:35 Microneedling associated with PDT : clinical cases .........................C33Matteo Tretti Clementoni, Milan, Italy


11:55 Plenary Session VII: Other indicationsHans-Christian Wulf / Robert Hunger

11:55 Impact of PDT on the immune system................................................C34Stefano Piaserico, Padova, Italy

12:05 Antimicrobial PDT in chronic leg and foot ulcers.............................C35Stan Brown, Leeds, UK

12:15 Clinical and microbiological healing of onychomycosis after3 sessions of conventional MAL-PDT vs placebo PDT.......................C36Yolanda Gilaberte, Huesca, Spain

12:25 Daylight-PDT in Italy ..............................................................................C37Dario Fai, Lecce, Italy

12:35 PDT for keloids .........................................................................................C38Ardeshir Bayat, Manchester, UK

12:45 MAL-PDT for mycosis fungoides: a prospective open studyand review of literature .........................................................................C39Gaelle Quéreux, Nantes, France


11

14TH Annual CongressHotel Le Méridien, NiceSaturday, 5th April 2014

08:00 Plenary Session IV: Management of AK in difficultareas and field cancerisationChristophe Bédane / Sally Ibbotson

08:00 PDT field treatment vs. lesion treatment in AK ...............................C19Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands

08:10 Comparison of MAL-PDT, Imiquimod and 5-FUin an observational study for AK patients.........................................C20Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands

08:20 Home-based laser device to warm the skin,as an alternative to curettage ..............................................................C21Peter Bjerring, Vejle, Denmark

08:30 Pain control strategies in patients receiving field-directed PDT..C22Ann-Marie Wennberg, Gothenburg, Sweden

08:40 Blue light to treat AKs ...........................................................................C23Christophe Bédane, Limoges, France


09:00 Plenary Session V: NMSCStanley Brown / Piergiacomo Calzavara-Pinton

09:00 DEBATE: PDT in sBCC Studies results => when choosing PDT for sBCCRianne M.J.P. Gerritsen, Njimegen, The NetherlandsNicole Kelleners-Smeets, Maastricht, The Netherlands

09:20 Temoporfin PDT for patients with multiple BCC...............................C24Ruud Horlings, Groningen, The Netherlands

09:30 MAL-PDT vs Imiquimod 5% cream for skin cancer prevention......C25Elena Sotirou, Thessaloniki, Greece

09:40 Combined Laser CO2 and PDT in sBCC and nBCC ..............................C26Max Murison, Swansea, UK

09:50 Dermoscopy for diagnostics and follow up after PDT of NMSCs....C27Philippe Bahadoran, Nice, France

10:00 Optical Coherence Tomography for diagnosis and follow-upafter PDT of NMSCs..................................................................................C28Martina Ulrich, Berlin, Germany

10:10 Pharmacoeconomic evaluation of MAL-PDT vsDiclofenac sodium for AK ......................................................................C29Piergiacomo Calzavara-Pinton, Brescia, Italy


10

13:05 Plenary Session VIII: Short oral presentationsof postersLasse R. Braathen / Rolf-Markus Szeimies / Jean-Philippe Lacour

13:05 Flow-cytometry versus fluorescence diagnosis as a prognostictool for evaluating the response to therapy in early casesof mycosis fungoides..............................................................................P01Manal Bosseila, Cairo, Egypt

13:10 PDT of BCC monitored by Optical Coherence Tomography ..............P02Lutz Schmitz, Wuppertal, Germany

13:15 Daylight-mediated PDT of AK: A randomized double-blindedprospective study to compare BF-200 ALAwith methyl- 5 -aminolaevulinate .........................................................P03Noora Neittaanmäki-Perttu, Helsinki, Finland

13:20 Antimicrobial Sonodynamic Therapy...................................................P04David Costley, Coleraine, Northern Ireland, UK

13:25 PDT with topical 5% 5-ALA compared to oral isotretinoinin the treatment of severe facial inflammatory cystic acne..........P05Evangela Papadavid, Athens, Greece

13:30 Awards and Closing remarksEURO-PDT Board

13:30 Award Ceremony - Best Poster - Best Oral Presentation

13:40 Closure Address - Local PresidentJean-Philippe Lacour, Nice, France

13:45 PDT Specialist - Accredited PDT Center - PDT Center of Excellence -Closure Address - EURO-PDT PresidentLasse R. Braathen, Bern, Switzerland

14:00 Closure of the Meeting

14:10 Lunch

12


AK .............Actinic KeratosisALA ...........Aminolevulinic AcidBCC............Basal Cell CarcinomanBCC .........Nodular BCCsBCC ..........Superficial BCCCR ..............Complete responseFx ..............FractionalLED............Light-Emitting Diode

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

Glossary

BACKGROUND: Topical photodynamic therapy (PDT) is a highly effective treat-ment option for actinic keratosis (AK). Hyperkeratosis of the AK impairs pe-netration of the photosensitizer and light and leads to a reduced efficacy.Therefore it is recommended to perform curettage of the AK prior to treatment.OBJECTIVE: To compare the effects of curettage (CUR), keratolytic pretreat-ment with salicylic acid 10% in petrolatum (SA) and urea cream 40% (UR)on efficacy and tolerability of PDT.METHODS: 44 subjects aged 51.9 ± 7.7 years (mean±SD) with multiple AK(mean 11.1 per patient) in face and scalp were analyzed in this retrospec-tive monocentric study. In 15 patients CUR was performed prior to the ap-plication of the photosensitizer. 15 and 14 patients underwent keratolyticpretreatment one day prior to PDT with SA and UR, respectively. Patients un-derwent one session of methylaminolaevulinate (MAL) PDT using a 630 nmlight emitting diode lamp at 37 J/cm2. Pain was measured using a visualanalog scale. Response rate was calculated using the documented number ofAK prior and 4 weeks after PDT.RESULTS: Patients with a keratolytic pretreatment with SA or UR experiencedsignificantly more pain (SA: 6.32 ± 2.7, p=0.02; UR: 6.1 ± 1.8, p=0.04) thanpatients with curettage (4.4 ± 2.1). Response rates were 68.5%, 61.4% and60.8% for CUR, SA and UR, respectively. Differences between the groups werenot significant (p=0.52). Side effects of curettage were slight bleeding andpain. Pretreatment with SA or UR led to mild erythema in most patients. Inthe UR group 2 patients showed distinct erythema and irritation of the skinand one patient even an erosion. However, the cosmetic result 4 weeks afterPDT was excellent in all three groups.CONCLUSION: Keratolytic therapy with SA or UR is an effective pretreatmentfor PDT of AK. However keratolytic pretreatment leads to an increase in painduring PDT and pronounced local reactions.

Influence of pre-treatmentwith urea cream 40% on face

and scalp AK on efficacy and tolerability

Patrick GholamHeidelberg, Germany

Ina Bosselmann, Alexander Enk

C2

18

Key Words: Pretreatment, Urea, Salicylic acid, PDT, AK

The evidence supporting the use of topical PDT across all dermatologicalindications has recently been reviewed with an updated extensive multi-national guideline on PDT currently under submission to the European Der-matology Forum.

The guideline provides evidence-based recommendations on the use ofconventional, ambulatory and daylight PDT in current and emergingindications, including use in immunosuppressed patients. Three agents arecurrently licensed for use in Europe for topical PDT: Methyl aminolaevulinate(MAL, Metvix®/Metvixia®), a nanoemulsion 5- aminolaevulinic acid(BF-200, Ameluz) and a patch also containing 5- aminolaevulinic acid,(Alacare®/Effala®).

Consideration of requirements for lesion preparation, optimal light dosi-metry, and aftercare are discussed, particularly for current indications: ac-tinic keratoses, Bowen’s disease, superficial and certain thin nodular basalcell carcinomas. Patient selection for PDT is addressed, with emphasis onthe advantage of PDT as a relatively selective field-directed therapy, use-ful in field cancerization, treating visible disease and delaying/potentiallypreventing new lesions. Normal and abnormal reactions to PDT are reviewed,along with options for diminishing treatment associated pain/discomfort.

Current Guidelines for PDT

Colin A. MortonStirling, Scotland, UK

C1

17

Morton, C.A., Szeimies, R.-M., Sidoroff, A. and Braathen, L.R., European guidelines for topical PDTpart 1: treatment delivery and current indications – actinic keratoses, Bowen’s disease, basal cellcarcinoma. JEADV 2013; 27: 536–544.Morton, C.A., Szeimies, R.-M., Sidoroff, A. and Braathen, L.R., European guidelines for topical PDTpart 2: emerging indications – field cancerization, photorejuvenation and inflammatory/infectivedermatoses. JEADV 2013; 27: 672–679.PDT subgroup of the EDF guideline committee, Guideline on photodynamic therapy, EDF, undersubmission.

Topical photodynamic therapy (PDT) is approved for treatment of UV-in-duced skin dysplasia and the phototoxic response correlates to the amountof accumulated protoporphyrin IX (PpIX). In vitro studies indicate thatPpIX is related to cell differentiation, and since vitamin D is a pro-diffe-rentiating hormone, we examined the potential of calcipotriol (CAL) to in-tensify PpIX fluorescence from methyl-aminolevulinate (MAL). Calcipotriolcream (50 µg/g) was applied for three days prior to topical incubation for3 hours with MAL cream (160 mg/g) in UV-exposed (n=19) and non-UV-exposed (n=21) hairless mice. PpIX fluorescence increased by calcipotriolpretreatment in both UV-exposed mice (UV median 23,870 vs. UV-CAL29,319 AU, P=0.006) and in non-UV-exposed mice (Control 18,712 vs. CAL30,075 AU, P<0.001). In calcipotriol pretreated mice MAL-induced PpIXfluorescence intensities were similar in UV-exposed mice compared to non-UV-exposed mice. In conclusion, calcipotriol enhances the formation ofMAL-induced PpIX fluorescence in both UV-exposed and non-UV-exposedskin.

Pretreatment with calcipotriol enhancesMAL-induced PpIX formation. A murine study

Christiane BayCopenhagen, Denmark

Christiane Bay, Catharina M. Lerche, Katrine Togsverd-Bo,Hans Christian Wulf, Merete Haedersdal

C4

20

Key Words: Calcipotriol, Cell differentiation, Hairless mice, MAL, PpIX

In acne with PDT, the two targets are sebaceous glands and Propionibac-terium acnes. The 2 main challenges are pain and secondary inflammatoryreaction. Protocols employing lower drug concentrations, low light doses,short incubation times are of interest and probably more likely to achievea shorter term effect via both direct antimicrobial or immunomodulatoryeffects. But the question of the effect on sebaceous gland is then raised.In contrast, high doses of PDT induce direct destruction of sebaceousglands but induce pain and a severe inflammatory reaction. Critical analy-sis of PDT studies, conclude that ALA- and MAL-PDT produce similar effectsand that red light is more likely to promote sebaceous gland destruction.In the majority of the randomized trials on a limited number of patients,the percentage of reduction is approximately 60% at 3 months. The futurewill be to discuss the place of daylight-PDT in acne.

PDT in acne: where do we stand,what's the future

Brigitte DrenoNantes, France

C3

19

Key Words: Acne, PDT

The main side effects of PDT in dermatology are post-treatment erythemaand oedema, and pain during illumination. Severe erythema after PDTenhances the down-time associated with the treatment.

The objective was to evaluate if topical corticosteroid before and after PDTwould reduce treatment induced erythema compared to conventional PDTafter treatment of AK in a randomized study.

Twenty-two patients with AK in the face and scalp were treated with methylaminolevulinate-PDT in two symmetrical areas. One area was randomized topotent corticosteroid (clobetasol propionate) before and after PDT.Erythema percentage and visual erythema was evaluated before and afterPDT as well as protoporphyrin IX (PpIX) fluorescence and pain score.

Topical corticosteroid significantly reduced PDT-induced erythema(p=0.012). The complete lesion response rate evaluated 3 months afterPDT and PpIX fluorescence prior to illumination did not differ significantlybetween the two treatment areas.

Potent corticosteroid before and after PDT reduced the erythema 24h aftertreatment of multiple AK in the face and scalp.

The use of topical corticosteroid did not affect the efficacy of PDT and maybe an easy way to make PDT treatment of large visible areas more acceptable.

A new approach to a gentle PDT treatment

Stine Regin WiegellCopenhagen, Denmark

Bibi Petersen, Hans Christian Wulf

C6

22

Key Words: PDT, AK, Erythema, Inflammation, Topical corticosteroid

We desire to make photodynamic therapy (PDT) as precise as possible,targeting the affected cells only, which may reduce tissue inflammation.In order to reach this goal we introduce a new PDT procedure with the aimto keep most PpIX within the affected cells to destroy these by apoptosis,and to avoid extracellular leakage resulting in inflammation and necrosis.To achieve this in the treatment of AK a MAL application time of only30 minutes is used, giving a pulse of MAL, while illumination is stillperformed after 3 hours. This will result in a significantly reduced amountof average PPIX fluorescence in an area treated for AK, and thus reduceinflammation. A study is presented showing reduced inflammation whilethe effect on complete remission of AK is unchanged 3 months aftertreatment. This treatment is called Pulse PDT.

A promising newway to reduce inflammationin PDT without reducing efficacy

Hans Christian WulfCopenhagen, DenmarkBibi Petersen, Stine Wiegell

C5

21

Objectives: In two Phase III studies in Australia and Europe, the efficacyand safety of daylight PDT [DL-PDT: methyl-aminolevulinate cream (MAL),involving 2-hour exposure outside during PPIX formation] was compared toconventional PDT (c-PDT: MAL with LED lamps) in treating facial/scalpactinic keratosis (AK).

Materials & Methods: These randomized, controlled, investigator-blinded,intra-individual non-inferiority studies included subjects with facial/scalpAK, treated with DL-PDT on one side vs. c-PDT on the contralateral side. Theprimary efficacy endpoint was complete lesion response at week 12 (non-inferiority margin of 15% in percent reduction of AK lesions), and primarysafety endpoint was subject’s self-reported pain.

Results: For both Phase III studies, at week 12 after one DL-PDT session,DL-PDT was non-inferior to c-PDT and subject-reported pain was lower withNDL-PDT.

Conclusion: These studies confirm previous Scandinavian findings thatDL-PDT can be considered an effective, safe and convenient alternative forthe treatment of facial/scalp AK.

Results of 2 randomised,controlled, phase III studies with

Daylight-PDT in Australia and Europe

Jean-Philippe LacourNice, France

C8

24

Key Words: AK, Conventional PDT, Daylight PDT, Methyl-aminolevulinate cream,Non-inferiority Phase III studies, Randomized controlled trial

Photodynamic therapy (PDT) is an effective conservative treatment foractinic keratoses (AK). However, pain and heterogeneous illumination fromrigid panels impede the treatment. To provide a more homogeneousillumination, we have developed a Light Emitting Fabric (LEF). This fabric,designed in three adjacent parts sequentially illuminated for one minutewith a low fluence rate (635 nm, 12 mW/cm², 150 minutes), enables treat-ment fractionation and pain reduction. The main objective of the study isto demonstrate that LEF-based PDT is at least as efficient as and bettertolerated than conventional PDT (630 nm, 37 J/cm², 75 mW/cm²). Theclinical evaluation approved by the French health authorities includes 42patients with 10 to 14 scalp AKs divided into two similar areas. The areasare randomized to either conventional PDT or LEF-based PDT. Treatmentresponse and tolerability are evaluated at 3 months follow-up and at 0 and7 days post-treatment, respectively.

New light sources (textiles) -First results of a study

Serge MordonLoos, FranceAnne-Sophie Vignion, Laurent Mortier, Jean-Claude Lesage, Nacim Betrouni,Olivier Carpentier, Cyril Maire, Eve Desmedt

C7

23

Key Words: AK, Clinical evaluation, Pain reduction, PDT, Woven fabric, Optical fibers

Photodynamic therapy (PDT) is a treatment option for malignant andpremalignant lesions in dermatology and is considered a fist-line treat-ment for multiple actinic keratosis and field cancerization. However, theconventional procedure requires trained staff and an optimal artificial lightsource. Moreover, its adverse effects (mainly the pain during irradiation)may also complicate the scenario, since treatment of large fields or parti-cular locations (face and scalp) can be especially painful and may needlocal anesthesia or treatment interruption. Daylight-PDT has been recentlydeveloped to simplify the conventional procedure. It has proved to reducethe treatment cost and the results are similar and less painful than conven-tional PDT. We herein describe the main issues regarding Daylight-PDT(studies available to date, results obtained in different types of skinlesions, adverse effects, advantages and disadvantages and futureperspectives) and also present our experience in a group of patients inSpain.

Clinical experience of Daylight-PDT in Spain

Lidia Comba Pérez-PérezVigo, Spain

Lidia Comba Pérez-Pérez, Yolanda Gilaberte, Juan Gavín

C10

26

Background: Efficacy of topical photodynamic therapy (PDT) for actinickeratosis (AK) is inferior in organ transplant recipients (OTR) compared toimmunocompetent patients. Furthermore, PDT is associated with treatment-related pain. We assessed a potential advantage of combining ablativefractional laser resurfacing (AFL) and daylight-mediated PDT (AFL-dPDT)compared to daylight PDT (dPDT), conventional PDT (cPDT) and AFL alone(AFL) in field treatment of AK in OTR.Materials and Methods: In each patient, four symmetrical skin areas wererandomized to a single treatment with cPDT, dPDT, AFL-dPDT and AFL. Suns-creen application and curettage was performed in all treatment areas be-fore randomization. AFL was delivered with a 2,940 nm ablative fractionallaser at 2.3 mJ/pulse, 1.15W, two stacks, 50 microsecond pulse-duration,2.4% density. In dPDT and AFL-dPDT, MAL incubated 2½ hours withoutocclusion during daylight exposure. For cPDT, MAL was left under occlusionfor 3 hours followed by red light (630 nm) irradiation at 37 J/cm2. Primaryend-point was complete lesion response (CR) 3 months post-treatment.Results: 16 patients with a total of 542 AK (grade I-III) in field-canceri-zed skin of the scalp, chest and extremities were treated from August –September 2012. At 3 months follow-up AFL-dPDT induced higher efficacyof 74% CR compared to dPDT (46%), cPDT (50%) and AFL (5%) for AKgrades I-III (p<0.001). In grade II+III AK, 66% of lesions cleared afterAFL-dPDT compared to 33% (cPDT) and 38% (dPDT) (p=0.001). Mean maxi-mal pain scores during AFL-dPDT (0.22), dPDT (0.1) and AFL (0.6) were si-gnificantly lower compared to cPDT (5.5) (p<0.001). Erythema and crustingwere slightly more intense following AFL-dPDT than dPDT and cPDT, buttransient hypopigmentation after AFL-dPDT was only observed in one patient.Conclusions: AFL-dPDT is a novel PDT modality that enhances efficacy withexcellent tolerability compared to dPDT and cPDT in difficult-to-treat AK inOTR.

Fx Laser + Daylight-PDT vs Daylight-PDT vsc-PDT vs laser alone in OTR

Katrine Togsverd-BoCopenhagen, DenmarkAM Erlendsson, EH Taudorf, HC Wulf, L Skov, M Hædersdal

C9

25

Key Words: AK, Daylight-PDT, Field cancerization, MAL, PDT, Skin cancer

In order to assess the feasibility and the therapeutic results of Daylight PDT(D-PDT), we used it to treat actinic keratosis in 18 consecutive patients.A sunscreen (Louis Widmer F15 Gel®)(SPF 15) was applied to all sunexpo-sed areas, and scales scraped off with a cürette. 16% Methylaminolevuli-nate (MAL) in a cream base (Metvix®) was applied to AK lesions, and after30 min. the patients went outdoors for 90-120 min.

Local skin reactions and its course were similar to conventional PDT usinga lamp for illumination, but contrary to conventional PDT there was nopain during the daylight illumination.

The mean overall lesional complete clinical response (CCR) for AK in the 18patients was 77%. Seven patients had previously had conventional PDTand had experienced various degress of pain during illumination. They werevery satisfied with the lack of pain with Daylight-PDT and expressed a pre-ference for D-PDT compared with conventional PDT.

Our experience with D-PDT is excellent. Patient compliance and satisfactionis high and the procedure is easy to carry out. In Switzerland the proce-dure can be performed from April to September. During the winter the day-light intensity and the temperature are low.

Clinical Experience of Daylight-PDTin Switzerland

Lasse R. BraathenBern, Switzerland

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Daylight photodynamic therapy (DPDT) is effective for actinic keratosis(AK). We have explored the use of DPDT in Scotland and treated 11patients with multiple areas of AK and field change carcinogenesis betweenApril to September 2013. Most patients had several areas treated (median6). All patients had reduction in the numbers of AK and extent of actinicdamage, with five having a very good response and six having a moderateresponse. Treatment was well tolerated (median pain score of one). Nineof the 11 patients expressed a preference for DPDT and would have treat-ment again. We see that there is a niche for DPDT in improving efficiencyof running of our PDT clinic, particularly for those patients with multiple,large areas of actinic damage, and we intend to expand this service further.

Clinical experience of Daylight-PDT in UK

Sally H. IbbotsonDundee, Scotland, UK

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Key Words: AK, Carcinogenesis, Daylight, Efficacy, Pain, PDT

Topical photodynamic therapy (PDT) with protoporpyrin IX precursors (ALAor MAL) in dermatology is basically a simple procedure. Many researchgroups have tried to optimize outcome and/or tolerability of PDT bymodifying the basic procedure usually making it more complicated, timeconsuming or costly. As an example pretreatment with a factional laser hasproven to be beneficial, but such devices are very expensive. The aim ofthis talk is to discuss the possibilities to reduce the complexity of theprocedure (for example with “daylight PDT” just to name one) and the risksthat go along with such an approach. These risks go beyond the obviousimpact of efficacy, and may have implications on the credibility of PDT inthe medical community and open the door for incorrect use.

Another way to simplify the PDT procedure is to combine light-source,cooling and dosimetry in an easy to use and flexible device hereby omit-ting the risks mentioned above.

How simple can it be? The art of omittance

Alexis SidoroffInnsbruck, Austria

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Key Words: Dermatology, Dosimetry, Fluorescence diagnosis, PDT, Skin cancer

• Started with blue light PDT 6 yrs ago (x 3 yrs).• Changed to Metvix® 4 yrs ago which I felt gave better results, longer re-missions with less treatments.• Biggest drawback was the pain.• Started daylight activation Spring 2012 which is better tolerated (80 ac-tivations).• Get more return patients willing to redo it if needed.• Possible to do April till November.• Have not tried it for acne yet (only one activated with red light).• Did one patient with sebaceous hyperplasia and rosacea who also had AK:the patient did find some improvement.

“Things I have Learned about Daylight PDT”

• Patient satisfaction is high but it should be clear this is not a cure andongoing monitoring still required.• Patients need to plan out their treatment so no surprises on day of treat-ment (ie are they going to activate outside the office or go home).• If home, can’t go in and out, so have all they need for 2.5 hrs readybefore hand.

Clinical experience of Daylight-PDT in Canada

Lori IngriselliSudbury, Canada

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Key Words: Longer remissions, Better tolerated, Patient satisfaction, More return patients

Light sources are crucial components for Photodynamic therapy (PDT). Dueto pain during illumination and homogeneity of exposure, in daily practicemost often small skin areas are irradiated. Incoherent lamps, laser-, IPL-,and LED systems showed already convincing efficacy, the latter one with avariety of systems already approved with the use of both ALA and MAL.Especially for the 5-ALA-containing patch (Alacare®, Galderma, Switzerland)the handheld LED system (AKderm™, Dermoscan, Germany), offering anirradiation area of 25 cm2 at a high fluence rate is a fully approvedmedical product designated to the treatment of small skin areas. Firstclinical impressions indicate similar efficacy compared to traditionalsystems. Patients reported about the occurrence of only mild-moderatepain (VAS 1-6) and a convenient treatment setting. From a practical pointof view, handheld PDT devices are an optimization especially for Patch-PDToffering a high flexibility of the work-flow in the dermatologist´s office.Further optimization can be achieved using a fluorescent ink to marklesions allowing redetection within 2-3 days without compromising thepatient.

Optimized light sources for Patch-PDT

Helger StegeDetmold, Germany

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Key Words: Handheld device, Optimization, Practical aspects

Recently, a 5-aminolevulinic acid containing patch (Alacare®) with inte-grated light protection for photodynamic therapy (PDT) of mild actinickeratosis (AK) was approved in Europe. Each patch has a size of 4 cm²,consists of a skin tone backing foil and a self-adhesive matrix, covered bya release liner which is removed prior to use.In clinical practice, the self-adhesive patches are easy to handle and main-tain high efficacy. Although, Alacare® is licensed for the treatment of mildAK of the scalp and face in a single treatment session it seems natural touse Alacare® PDT also for small plaques of squamous cell carcinoma in-situ(SCC) and superficial basal cell carcinoma (sBCC). For both indicationstherapy guidelines recommended PDT with a conventional cream ointmentas the treatment of choice or as good choice, respectively. The majority ofplaques of SCC in-situ and sBCC are small sized and sometimes located onpoor healing sites such as the foreside of the tibia. The self-adhesive Ala-care® patches containing 5-ALA can easily be applied even on convex sha-ped anatomical sites and will cover most of the SCC in-situ and sBCC. Inthese cases a pretreatment of the lesions by gentle scraping is recommen-ded and PDT should be performed in two treatment sessions.In conventional PDT pain and burning sensations are frequent side effectslowering the acceptance of photodynamic treatment procedures. Incontrast to the field-directed conventional PDT can Alacare® patches beapplied lesion-directed. A limited treatment area induces fewer side effectsespecially burning sensations. Therefore, Alacare® patches will alleviatepain and discomfort during PDT. The combination of new illuminationtechniques such as portable LED devices e.g. AKderm® with 5-ALA patchesallows to illuminate limited areas in direct contact to the skin surface andwill minimize side effects furthermore.In summary, 5-ALA patches contribute to a wider acceptance of photody-namic therapy and offer more indications for PDT even at convex shapedskin surfaces.

Patch-PDT: routine use in an office-basedsetting

Holger PeteringHildesheim, GermanyHolger Petering, Maribel Müller, Ina Röhrig-Petering

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We report a case of an intraepidermal squamous cell carcinoma (initialBowen’s disease) in a 86-years old woman on her right lower leg. Due tochronic anticoagulation, PDT with a self-adhesive 5-ALA containing patch(Alacare®, Galderma-Spirig, Germany) was suggested as treatment option.Without further pretreatment the patch was applied to the histologicallyconfirmed Bowen’s disease with an overlap of 5 mm. Duration of applicationwas 4 hours, illumination was performed with a handheld LED red lightsource (AKderm™, Dermoscan, Germany; 37 J/cm²). Treatment was repea-ted one week later. At follow-up 2 months later, the patient showed a com-plete clinical clearance of the lesion. Due to the small size of the treatedarea analgesia was not necessary. As side effect only an erythema occur-red.

In this off-label indication, the self-adhesive 5-ALA patch was an effectivetreatment of Bowen’s disease with an excellent clinical and cosmetic out-come.

Patch-PDT for intraepithelial SCC

Swantje EhrigRecklinghausen Germany

Swantje Ehrig, Rolf-Markus Szeimies

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Key Words: Bowen’s disease, Handheld LED, Patch-PDT

Photodynamic therapy (PDT) has been tried recently in patients with actiniccheilitis. Repeated topical PDT with aminolaevulinic acid (ALA) or itsmethylated ester (MAL) cured actinic cheilitis in about 50-65% of allpatients. However, histopathological clearance was found in only abouthalf of all clinically cured lesions. During a follow-up period of 18 monthsdisease recurrence was observed in more than 20% of patients.

To optimise ALA absorption and cellular uptake we used Alacare® patchesfor PDT treatment of actinic cheilitis. Alacare® patch is a thin, self-adhe-sive, skin-coloured 4 cm2 patch containing 8 mg 5-ALA. It can be ap-plied directly to the lesional skin without prior crust removal.

We performed Alacare®-PDT in a small group of ten patients with actiniccheilitis of varying severity. The clinical diagnosis was confirmed in allcases by histopathological examination. The results of our pilot studyindicate that Alacare®-PDT might evolve as a promising approach to themanagement of actinic cheilitis.

Patch-PDT: convenient and effectivefor actinic cheilitis?

Sonja RadakovicVienna, Austria

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Key Words: Actinic cheilits, Alacare®, Patch-PDT

The number of patients with actinic keratoses (AK) is increasing rapidly, includingpatients with field-cancerization. (Field) treatment, necessary to prevent evolu-tion of AK into squamous cell carcinoma, causes a burden on healthcare-systems.Information on patients’ characteristics and treatment costs in AK are scarce andbased on medical trials, which do not reflect real clinical practice.The aim of our study was to investigate:- Characteristics of patients with AK who choose PDT, 5-FU or Imiquimod;- The cost-effectiveness of MAL-PDT.Materials & Methods: In an observational multi-centre study, we collected one yearfollow-up data of patients with AK on the face and/or scalp initially treated withMAL-PDT, Imiquimod (IMI) or 5-Fluorouracil cream (5-FU).Results: A total of 320 patients were included; 104 patients (M: 32.5 AK) weretreated with MAL-PDT, 106 patient (M: 20.2 AK) with IMI, and 110 patients(M: 22.8 AK) with 5-FU. At baseline, patients in the MAL-PDT group were moreseverely affected with number and location of AKs, previous skin tumours, previoustreatments for AK, quality of life, and health condition. After 12 months, we notedthe highest absolute reduction of AK in the MAL-PDT group 25.8±16.3.The chanceon more than 75% lesion reduction, corrected for the number of lesions on M0, wassignificantly highest in 5-FU. There was no significant difference between MAL-PDT and IMI. Treatment and follow-up costs of MAL-PDT were significantly higheras compared to IMI or 5-FU. In the pharmaco-economic evaluation, only small dif-ferences in the outcome parameters were found. MAL-PDT was found to be most ef-fective in terms of cosmetic outcome, while 5-FU yielded the most responders.Conclusion: We encountered significant baseline differences between patient groupswho had the opportunity to choose their own treatment in this observational study.MAL-PDT was chosen by patients who were most severely affected. MAL-PDT, ho-wever, was significantly more expensive as compared to 5-FU and Imiquimod,mainly caused by the costs of the day care setting, as is common in the Nether-lands, and the costs of Metvix®, but had better cosmetic outcomes.

Comparison of MAL-PDT, Imiquimod and 5-FUin an observational study for AK patients

Rianne M.J.P. GerritsenNijmegen, The Netherlands

M.J.P. Gerritsen, M.C.J van Rijsingen, I. Seubring, J.P.C. Grutters,M.B. Maessen-Visch, J.A.C. Alkemade, R. Van Doorn, J.M.M. Groenewoud

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Key Words: MAL-PDT, Real life practice, Observational study

AK lesions are often treated separately, from lesion to lesion. However, in recentyears, AK have been described to be a field disease and not limited to single clini-cally apparent lesions. In the definition of field cancerization, clinically normal ap-pearing skin, surrounding AK and SCC, contains subclinical features of geneticallydamaged cells which may develop into new AK or SCC. Treatment may therefore pre-ferably target an area of field change which may reduce the risk of development offurther AK, new tumours and local recurrence.Objectives: Primary objectives: Relapse rate of AK, incidence of new lesions at 9months after PDT treatment and the time for new lesions to develop. Secondary ob-jectives: Number of new lesions at 3 months and 6 months post treatment and thepercentage reduction of AK from baseline at 3 months and 6 months post-treatment.Study design: A single centre, prospective, randomised, split face, investigator blind,investigator initiated post marketing study, in patients with AK. Patients should haveat least 5 up to 10, grade I or II, AK lesions, in each of two 50 cm2 contra-lateralareas, on the face or scalp, symmetrically distributed (number and severity). Oneside was treated with ‘lesion to lesion’ MAL-PDT; the other side with ‘field’ MAL-PDT.A nonparametric two-sided Wilcoxon signed rank test was used to analyze the per-centage reduction from baseline and for number of new lesions.Results: The baseline characteristics in both treatment areas were comparable. Atbaseline mean AK was 8.6 ± 1.6 vs. 8.95 ± 1.2. At M3, M6 and M9, we noted a si-gnificant reduction (p=.000) of lesions in both areas. At M3 and M6, no significantdifferences between both treatment protocols were found with respect to lesionreduction or number of new lesions. At M9, the number of remaining AK was signi-ficantly lower in ‘the lesion to lesion’ treated area (p = .013), whereas the numberof new lesions was significantly lower in the ‘field treated’ side (p=.014).Discussion: The results may well reflect the fact that when treating a mean of 8-9 AKin a field of the size of 50 cm2, we are approaching a field treatment. One may alsodiscuss whether it may be advisable, when performing a field treatment, to applicatethe cream to the whole area, followed by extra attention for application of the creamto the visible lesions.

PDT field treatment vs. lesion treatmentin AKRianne M.J.P. GerritsenNijmegen, The NetherlandsRianne MJP Gerritsen, Inge Seubring

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Key Words: MAL-PDT, Field treatment, Lesion to lesion, AK

Photodynamic therapy (PDT) is an effective therapy against actinickeratosis and superficial basal cell carcinoma. However, pain is a bothersomeside effect making treatment impossible in some instances.

Simple measures like a fan or spraying water may be enough in some cases.Recently, Daylight-PDT has become an alternative as it seems that pain isa minor problem. However, due to the climate in Northern Europe treatmentis practically impossible during the winter months.

In our group, nerve block has been used with success. The mean VAS scoreon the blocked side of the face was 1.3 compared with 7.5 +/- 0.5 on thenon-anaesthetized side using a 10 grade Visual Analogue Scale (VAS).

Consequently, there are several techniques that may be used to combatpain during and after PDT.

Pain control strategies in patientsreceiving field-directed PDT

Ann-Marie WennbergGothenburg, Sweden

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Key Words: Customized pain control, Different PDT protocols, Nerve block

Efficient pre-treatment is of paramount importance for the clinical resultof PDT.

Reduced penetration of photosensitizers for PDT through crusts and hy-perkeratinized epidermal layers may reduce treatment efficacy.

Previous studies of laser ablation of stratum corneum and fractional abla-tive laser treatment have shown highly increased 5-ALA and MAL inducedskin fluorescence.

A low cost, non-ablative, fractional 1425 nm diode laser was used to ge-nerate fractional coagulation zones followed by application of 5-ALA. Theskin penetration and formation of PPIX was monitored objectively by skinfluorescence.

Compared to non-treated control skin, the skin fluorescence at the lasertreated area was increased by 135%.

Pre-treatment with a non-ablative, low-cost laser intended for home-treat-ment skin rejuvenation is a fast and cheap method to increase penetrationand subsequent conversion of 5-ALA and MAL into PpIX without pain, blee-ding or discomfort.

Home-based laser device to warm the skin,as an alternative to curettage

Peter BjerringVejle, Denmark

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Key Words: Non-ablative fractional laser, PDT, Pre-treatment, Epidermal penetrationenhancement

In photodynamic therapy (PDT) using the intravenously administered pho-tosensitizer meta-tetrahydroxyphenylchlorin (mTHPC), patients become ge-neralized photosensitive. By shielding the healthy normal skin duringillumination, selective illumination of multiple non melanoma skin can-cers (NMSC), up to 10mm depth can simultaneously take place. Previouslyperformed studies showed high tumour clearance rates (up to 100%, de-pending on the treatment parameters used), with relative few side effectsand excellent cosmetic and functional outcomes. Own experiences withfour (therapeutic challenging) patients with an on-going proliferation ofNMSCs demonstrated consistently good cure rates and an acceptable dura-tion of photosensitivity after the procedure, but healing times that greatlyvaried between anatomical areas. The head and neck area heals cosmeti-cally well, while the lower leg and foot area shows delayed, sometimescompromised healing with scarring. Although promising, there is requisiteof a randomised clinical trial to compare this therapy with conventionaltreatments, to show its clear benefits.

Temoporfin PDT for patients with multiple BCC

Rudolf HorlingsGroningen, The NetherlandsR.K. Horlings, J.B.Terra, M.J.H.Witjes

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Key Words: Meta-tetrahydroxyphenylchlorin (mTHPC), NMSC, PDT

Background: Photodynamic therapy with ALA and blue light has beenshown to be safe and effective in the treatment of actinic keratosis (AK).To date no study was performed using methyl aminolevulinate in combi-nation with blue light for the treatment of large areas of AK on the scalpand the faceObjectives: To evaluate the efficacy, tolerance and safety of blue light il-lumination after MAL sensitization of grade I and II AK of the face andscalp.Patients and methods: 100 patients have been included in this prospectivestudy 10 female and 90 male patients. AK were counted and located byphotographs and templates. MAL was applied on the face or the scalp for3 hours under occlusive dressing before blue light illumination (10joules/cm² 450 nm). Pain was evaluated during treatment and immediatelyafter soft cream application. Efficacy and tolerance were evaluated after 1,3 and 6 months.Results: 89 patients were evaluable the average number of AK was 33mainly located on the scalp (75%). 95% were grade I or II and 13% gradeIII AKs. The clearance rate was 89.9% at 1 month 91% at 3 months and89.8% at 6 months. At 6 months the average number of new AK on thetreated area was 2 AKs. Grade 1 and II AKs showed a better clearance ratethan grade III AKs (94.4 versus 86.5%)The average pain evaluates on VAS was 8 during treatment and was decrea-sed to 4,5 after soft cream application immediately after illumination. 97%of patients were satisfied or very satisfied by the treatment.Conclusion: This study confirms that MAL PDT combined with blue light il-lumination is an effective and well tolerated treatment allowing the controlof large cancerization fields. Results are reproducible and only very few AKrecur after 6 months survey.

Blue light to treat AKs

Christophe BédaneLimoges, FranceSafae Assikar, Christophe Bédane, Cecilia Enescu and Sophie Léobon

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Methods: One hundred ten patients with a total of 177 lesions mainly onthe head and neck were treated with combined therapy using an Ultra-Pulse CO2 laser and PDT using Methyl Aminolevulinate at the same sitting,with repeat PDT 1 week later.

Results: A total of 177 lesions were diagnosed and treated. Only biopsy-proven BCCs were included in this study. All lesions responded to treatmentas assessed by clinical evaluation with regular follow-up. The total recur-rence-free rate was 97.1% at a mean follow-up period of 32.2 months.Recurrences were noted in 5 (2.82%) cases. All recurrences were treatedsuccessfully, all but one using repeat laser-PDT. One patient underwent sur-gical excision. No significant complications were encountered, althoughmild hypopigmentation was occasionally seen and some discomfortwas ex-perienced with PDT.

Conclusions: Combined CO2 laser and PDT have equivalent cure rates tosurgery for BCCs. These modalities acting synergistically, this strategyprovides cure often with scarless outcomes as illustrated.

Combined Laser CO2 and PDT in sBCC and nBCC

MaxMurisonSwansea, UK

Kayvan Shokrollahi, Mohammed Javed, Karen Aeuyung, Amar Ghattaura,Iain S. Whitaker, Barbara O’Leary, William James, BSc and Maxwell Murison

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Key Words: BCC, 5-ALA, CO2, Laser, MAL

Objectives: To compare efficacy and safety of MAL- PDT versus IMIQ 5%in the prevention of new NMSC development in patients with field changes.

Methods: Patients with face or scalp field cancerization were randomizedto receive MAL-PDT on one side, and IMIQ 5% on the mirror field. Primaryendpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events,patient preference and cosmetic outcome. Statistical analysis wasperformed using two-sided Wilcoxon paired samples test.

Results: Forty-four patients were included. Both treatment regimens didnot statistically differ concerning the primary endpoint and were safe andwell tolerated. Patients’ preference favored MAL-PDT. With regards tocosmetic outcome no statistically significant differences were recorded.

Conclusions: MAL-PDT and IMIQ 5% equally prevent development of newAKs in patients suffering from field changes. MAL-PDT appears to besuperior in terms of patients’ preference.

MAL-PDT vs Imiquimod 5% cream for skincancer prevention

Elena SotiriouThessaloniki, Greece

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Key Words: Field cancerization, Imiquimod 5% cream, MAL-PDT, NMSC,Skin cancer prevention

Photodynamic therapy (PDT) represents an efficient and widely used treat-ment for different forms non melanoma skin cancer (NMSC) includingmainly actinic keratoses and basal cell carcinoma. One of the main ad-vantages of PDT is the excellent cosmetic outcome. Therefore, obtainingpre- and post-treatment biopsies is not feasible and small biopsies areoften not representative. As several features such as individual tumor typeand thickness may have a great influence on the treatment efficacy, noveldiagnostic techniques such as optical coherence tomography (OCT) maysolve this problem.

OCT is a non-invasive imaging technique providing vertical images of theskin that are similar to those of ultrasound, but have a much greater re-solution. Thus, OCT allows the detailed analysis of the epidermis and theupper dermis and enables the detection of non melanoma skin cancer suchas basal cell carcinoma and actinic keratoses. As OCT imaging is comple-tely non-invasive the skin tumor may be evaluated over time and withoutartificial alteration of the tissue. In this regard, OCT may be used for theinitial diagnosis and monitoring of basal cell carcinoma and actinic kera-toses under treatment with PDT. The use of OCT enables the dermatologistto analyze the tissue at high resolution, detect possible residual tumor orthe clearance of a lesion and guide treatment.

Optical Coherence Tomography for diagnosisand follow-up after PDT of NMSCs

Martina UlrichBerlin, Germany

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While the possibilites of treating non-melanoma skin cancers (NMSC) withmedical instead of surgical approaches is increasing rapidly, there is a growingneed for non-invasive diagnosis and monitoring tools to accompany thesenon-invasive therapies. Dermoscopy is widely used by dermatologists forthe diagnosis of basal cell carcinomas (BCC). Recently it was demonstra-ted that dermoscopy is useful to distinguish superficial and nodular BCC,an important challenge regarding the choice of a medical or surgicalapproach, and also for the monitoring after non-ablative therapies forBCC. In addition dermoscopic criterias for the diagnosis of actinic keratoses(AK) and squamous cell carcinomas (SCC) have been reported recently.These advances in dermoscopy of NMSC and similar approaches using moreadvanced imaging techniques such as Reflectance Confocal Microscopy andHigh-Definition Optical Coherent Tomography will be presented during thistalk.

Dermoscopy for diagnostics and follow upafter PDT of NMSCs

Philippe BahadoranNice, France

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Key Words: BCC, SCC, AK, Dermoscopy, Reflectance confocal microscopy,High-definition optical coherent tomography

Actinic keratosis (AK) may progress to squamous cell carcinoma. In case ofisolated lesions developing on normal or mildly photodamaged skin,aggressive lesion-directed physical treatments are considered valuableoptions despite poor published evidence of their therapeutic activity.

200 patients with a total number of 543 AK were enrolled in a randomizedtrial. The CR rates of lesions after 3 months were 78.2 % with cryotherapyand 72.4% with CO2 laser ablation. Thicker lesions were significantly moreresponsive to cryotherapy (p=0.034). Seventy-three patients (71.6%) hadCR of all lesions 3 months after cryotherapy and 64 (65.3%) after laserablation. At 12 months after treatment the number of patients with CRwas reduced to 53 with cryotherapy and 14 with laser ablation.

The rate of patients and lesions with CR is similar after 3 months but morepatients remain in stable remission for 12 months after cryotherapy.Cryotherapy is more effective for thick lesions. The cosmetic outcome wasgood or excellent in almost all patients. The role of locally destructivetreatments after the development of conservative treatment options, suchas MAL-PDT, in the treatment of isolated AK remains to be fully clarified.

Cryotherapy is preferable to ablative CO2laser for the treatment of isolated AK of the

face and scalp: a randomised clinical trial

Cristina ZaneBrescia, Italy

Cristina Zane, Piergiacomo Calzavara-Pinton

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Key Words: AK, Laser, Cryotherapy

The aim of the present single-centre, open-label, prospective, non-spon-sored, randomized, controlled clinical trial was to compare the treatmentresults and cost effectiveness of MAL-PDT and diclofenac with hyaluronicacid (DHA).

Two hundreds patients with a total number of 1674 AKs were enrolled. Thelesion CR rates at 3 months were 85.9% with MAL-PDT and 51.8% withDHA (p<0.0001). AK of all thickness grades were significantly moreresponsive to MAL-PDT. The patient CR rates at 3 months were 68.4% withMAL-PDT and 27.0% with DHA. At the 12 months' examination, the num-ber of CR patients reduced to 37 with MAL-PDT and 7 with DHA. Rating ofcosmetic outcome was very good or excellent in the vast majority of CRpatients with both treatments. The analysis of cost/ effectiveness showedthat the costs per CR patient at 3 months and at 12 months are 566.7 €and 1026.2 €, respectively, with MAL-PDT and 595.2 € and 2295.6 €,respectively with DHA.

Efficacy, cosmetic outcome and patients' overall satisfaction of MAL-PDT aresuperior in comparison to DHA. MAL-PDT is more expensive but it is morecost-effective.

Pharmacoeconomic evaluation of MAL-PDT vsDiclofenac sodium for AK

Piergiacomo Calzavara-PintonBrescia, ItalyCristina Zane, Piergiacomo Calzavara-Pinton

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Key Words: AK, MAL, PDT, Diclofenac

Topical PDT is an approved treatment for superficial non-melanoma skincancers. Currently, it is also being used to treat severely photodamagedskin with multiple actinic keratosis (AK). In order to enhance photosensi-tizer penetration into the epidermis, fractional CO2-lasers or microneedlingdevices (MN) are combined with PDT.The author will present a review of li-terature and the results of a split-face study comparing conventional MAL-PDT with MN-assisted PDT. Ten patients (9♀and 1♂, mean age 67.3 yrs.)with symetrically distributed AKs and photodamage were included and ran-domized to receive conventional MAL-PDT (Metvix®, Galderma, Brazil) withprevious gentle curettage in one side of the face vs. MAL-PDT combinedwith 1.5 mm high microneedling (Dermaroller®, Wolfenbüttel – Germany)on the other, just after MAL application. After 90 min of incubation, pa-tients were illuminated with red LED light (Aktilite®, Galderma, 635 nm,37 J/cm²). Patients were evaluated for improvement of photodamage, clea-rance of AKs and side effects before and after 30 and 90 days. At day 30,global scores for photodamage, mottled pigmentation, roughness, and sal-lowness improved on both sides (p < .05), but fine lines improved only onthe MN-PDT side (p = .004). At day 90, facial erythema (p = .04) andcoarse wrinkles (p = .002) also improved on the MN-PDT side, in additionto fine lines for conventional MAL-PDT (p = .01). Erythema (p = .009),edema (p = .01), crusting (p = .01) and pain(p = .004) were more commonand intense on the MN-PDT side. One patient developed a secondary bac-terial infection at day 7 on the MN-PDT side. Average AK clearance was88.3%, with no difference between the sides.Microneedling-assisted PDT is a safe and effective method and can pro-duce superior cosmetic results to conventional MAL-PDT for improving pho-todamaged skin. Further larger prospective studies are needed to determinewhether the addition of MN decreases AK.

Conventional MAL-PDT with microneedlingon actinically damaged skin

Luis TorezanSao Paulo, Brazil

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Key Words: MAL, PDT, Microneedling, AK

Besides high efficacy in NMSC, topical PDT with photoactivable porphyrinsalso provides an excellent cosmetic outcome. Meanwhile skin rejuvenatingeffects of PDT for photoaged skin have been well-documented in severalclinical trials. Improvements of lentigines, skin roughness, fine lines andsallow complexion were reported with PDT. These clinically evident effectsare at least in part due to histologically proven increase of collagen anddecrease of elastotic material in the dermis. In the second consensusconference of German Dermatologists involved in the field of aestheticphotodynamic therapy, practical aspects, such as recommendations fortreatment protocols for the different anatomical regions exposed to chro-nic sun damage like face, neck, décolleté and the back of the hands andsuitable procedures for pre- and after care were made. The possibility ofcombination procedures, like fractional laser systems, microneedling andthe correct choice of timepoints for other procedures like injection of fil-lers or botulinum toxin were discussed and practical tips were given.

PDT for skin rejuvenation:German consensus on practical aspects

Rolf-Markus SzeimiesRecklinghausen, Germany

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Key Words: PDT, Aesthetic procedures, Dermal remodeling, Skin rejuvenation

Most of data concerning the impact of Photodynamic therapy (PDT) onimmune system have been described in animal models or using systemicPDT for the treatment of solid tumors. There are reports based on data fromin vitro studies that PDT can have an effect on monocyte/macrophage andlymphocyte cell lineages. Lymphocytes are usually easily killed by PDT, andactivated lymphocytes are especially susceptible.

In healthy human skin, topical PDT induces significant changes to leuco-cyte trafficking. An early infiltration of neutrophils peaks at 4 h post-PDTand the number of T lymphocytes gradually increases up to 24 h post-PDT.In contrast, Langerhans cells significantly decrease in numbers in the epi-dermis after PDT. In agreement with data obtained from healthy humanskin, also biopsies from BCCs showed topical PDT-induced reduction in Lan-gerhans cells. However, this phenomenon has only been studied on a shorttime-period after PDT.

In order to evaluate the duration of the PDT-induced Langerhans cellsreduction we performed skin biopsies before and 30 days after MAL-PDT.

After 30 days, the number of Langerhans cells were similar to the baselinevalues.

Impact of PDT on the immune system

Stefano PiasericoPadova, Italy

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Key Words: PDT, Immune system, Immunosuppression

Background: High efficacy and safety, coupled with in-office, short contactprotocols have made photodynamic therapy (PDT) with aminolevulenic acid(ALA) for the treatment of actinic keratoses a mainstay option over the lastdecade. Clinical improvement in photoaged skin has also been reported toaccompany PDT treatments. The study objective was to maximize epider-mal penetration and subsequent activation of ALA for the treatment ofphotodamaged facial skin, utilizing a microneedle roller prior to incubationand combined irradiation with red light and broadband pulsed light in asingle treatment.Materials and Methods: A full-face treatment of 91 patients was performedwith 630nm light and broadband pulsed light after multiple passes with amicroneedle roller (needle length 300µm – 500 µm depending on the skinthickness) and 1-hour ALA incubation. The primary endpoint was clinicalimprovement, scored during two separate live assessments by three physiciansblinded to previous scores, using a 5-point standardized photoaging scale. Thesecondary endpoint was evaluation of patient satisfaction based on a quartilescale comparing baseline to 6-month post-treatment photography.Results: Statistically significant improvement was seen in the globalphotoaging scores, as well as sub-components of the scale (fine lines, mot-tled pigmentation, sallowness, tactile roughness, and telangiectasias) at3 months as compared with baseline live assessment, and at 6-month liveassessment compared with the 3 months. In addition, 90% of patients judgedclinical improvement to be greater than 50% at 6 months compared tobaseline photography.Conclusion: Use of a microneedle roller to ‘‘pre-treat’’ prior to applicationof ALA appears to be well tolerated and allows for even absorption andperhaps deeper penetration of ALA following a defined incubation period.Use of red light and broadband pulsed light allowed for deeper activationof ALA, potentially accounting for marked clinical improvement in photoaging.

Microneedling associated with PDT :clinical cases

Matteo Tretti ClementoniMilano, Italy

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49

Onychomycosis is a fungal nail infection affecting up to 13% of the gene-ral population. Photodynamic therapy (PDT) could be very convenient totreat onychomycosis, especially considering the limited efficacy of theconventional treatments and possible side effects and frequent interac-tions. Different case reports and short series have shown promising resultsfor the use of MAL-PDT to treat onychomycosis.

We are conducting a multicentre, randomized, placebo-controlled clinicaltrial comparing 3 sessions of conventional MAL-PDT with placebo-PDT inonychomycosis. Patients both clinically and microbiologically diagnosedwith onychomycosis were included in the study. They were randomized toeither 3 sessions, 1 week apart of conventional MAL-PDT (MAL 3 hoursunder occlusion and irradiation with Aktilite® 37 J/cm2) or placebo PDT(irradiation only). Nail plates were softened with 40% ointment urea be-fore PDT session. Efficacy is evaluated blindly, both clinically and micro-biologically. Additionally, the impact of onychomycosis on quality of lifeis evaluated.

The study started in March 2013 and 60 patients have been included. Allof them are being followed for 9 months. Preliminary results will be pre-sented.

Clinical and microbiological healing ofonychomycosis after 3 sessions

of conventional MAL-PDT vs placebo PDT

Yolanda GilaberteHuesca, Spain

Yolanda Gilaberte, Pilar Robres, Elisabeth Gómez-Moyano, Carmen Aspiroz,Miguel Lova, Daniel J. Godoy, Antonio Rezusta, Ignacio García-Doval

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Key Words: Onychomycosis, Clinical trial, MAL, PDT

Background: With increasing problems of antibiotic-resistance, PDT is beingdeveloped as an anti-microbial treatment. The objective was to determineif repeated applications of PDT with PPA904, a methylene blue analogue,in bacterially colonised hard to heal chronic ulcers can reduce bacterialload, and potentially lead to improved wound healing.

Methods: 48 subjects were randomised to either weekly doses of PPA904and light or placebo and light for up to 12 weeks. All patients had ulcerduration > 3 months, bacterially colonised with >104 cfu/ml. Bacterialload was measured via swabbing and ulcer area was measured for up to 3months following treatment.

Results: Primary analysis showed a greater bacterial load reduction forsubjects receiving PPA904 and light, compared to placebo and light(p<0.001), with a greater decrease in bacterial load with PPA904 comparedto placebo over all weeks (p<0.0001) and with a non-significant trendtowards healing compared to placebo.

Antimicrobial PDT in chronic leg and foot ulcers

Stan BrownLeeds, UK

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51

Key Words: Antimicrobial PDT, Chronic diabetic foot ulcers, Chronic leg ulcers,Wound healing

Optimal management for keloid scarring or keloid disease (KD) remainsunknown, with surgical excision resulting in high recurrence rates. In vitroexperiments show that cytotoxicity post-PDT in keloid scar fibroblasts isdependent on the lesional site, precursor of intracellular photosensitiserand the fluence rate. In a clinical case series, Methyl Aminolevulinate(Metvix®) photosensitiser, was applied to keloid scars three hours prior toPDT. All patients had reduced pain and itch scores. Haemoglobin flux,collagen and haemoglobin levels all decreased significantly from week 1 to3 in all except one patient where measurements were taken (p=0.032,p=0.066, p=0.060 respectively) and pliability increased significantly(p=0.001). Increases in pliability were matched with decreases in flux(p=0.001). Minimal side effects were reported. PDT reduces scar formationin KD evidenced by absence of recurrence post treatment in the period offollow up as well as decreased blood flow, increased pliability, decreasedcollagen and haemoglobin levels.

PDT for keloids

Ardeshir BayatManchester, UK

C38

54

Photodynamic therapy (PDT) is a well-established procedure for the treat-ment of actinic keratoses (AK) and non-melanoma skin cancers. PDT has va-rious advantages, including overall high response rates, excellent cosmeticoutcomes, and the possibility of treating large areas, such as the AK-as-sociated field-cancerized areas. Pain during illumination is one of the mostrelevant side effect reported by patients treated with PDT, and may beparticularly severe in some patients, especially in those with multiple le-sions of the face and the scalp. Daylight PDT is a novel modality of PDTin which the activation of the topical photosensitizer is mediated by theexposure to daylight instead of artificial light sources without the need ofpreliminary incubation. This simplified modality is less time-consumingand has been shown to be better tolerated.

We report our experience with daylight PDT in a cohort of 53 patients withactinic keratoses. Their lesions were thin or intermediate/moderate thick(clinical grade I and/or II), and most AK were in areas of field canceriza-tion. Scales and crusts were gently scraped, and then 16% methylester of5-aminolevulinic acid (MAL) cream was applied without occlusion. The-reafter, patients were instructed to remain indoors, in the dark, for 30 minand then to expose themselves to daylight for 2 hours (in all weatherconditions except rain). Of note, our personal protocol of daylight PDT didnot include the preliminary application of a sunscreen.

Daylight PDT in Italy

Dario FaiLecce, ItalyD. Fai, N. Cassano, G.A. Vena

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53

Key Words: AK, Daylight

55

Publications reporting photodynamic therapy (PDT) as a treatment formycosis fungoides (MF) are rare, involve small samples and are difficult tocompare due to a lack of technical standardization.

We conducted a prospective study to assess PDT effectiveness and tolera-bility in early-stage MF (stage IA or IB). MAL-PDT sessions were repeatedmonthly for 6 months. Clinical and histological responses were assessed 1month after the last session. Patient satisfaction was assessed by tele-phone survey.

Twelve patients (with 29 lesions) were treated with PDT. An objective res-ponse in target lesions was obtained in 75% of patients. Response rateswere similar between plaques and patches but higher in sun protectedcompared to sun-exposed areas (trend without reaching significance).During PDT, new lesions appeared in 5/12 patients in untreated areas. Mostpatients were highly satisfied and preferred PDT to the topical chemothe-rapy previously used.

In early-stage MF, PDT is effective and appreciated.

MAL-PDT for mycosis fungoides: a prospectiveopen study and review of the literature

Gaëlle QuéreuxNantes, FranceGaëlle Quéreux, Anabelle Brocard, Mélanie Saint-Jean, Lucie Peuvrel,Anne-Chantal Knol, Rémy Allix, Amir Khammari, Jean-Jacques Renaut, Brigitte Dréno

C39

Key Words: Cutaneous T-cell lymphoma, MAL, Mycosis fungoïdes, PDT, Satisfaction survey,Prospective study

BCC is the most common type of skin cancer in the adult white populationand shows an increasing incidence worldwide. Photodynamic therapy (PDT)with methyl aminolevulinate (Metvix®) is an optional non-invasive treat-ment for superficial and nodular BCC, especially in risk-hafted, elderly pa-tients. The maximal vertical infiltration depth, however, limits the use ofPDT. Optical coherence tomography (OCT) is a reliable non-invasive imagingtechnique for diagnosing and monitoring BCC in-vivo.

The aim of the present retrospective study was to evaluate the outcome ofPDT according to the initial tumor thickness. We investigated 19 BCC le-sions with a median tumor thickness of 0.47mm in 13 patients before andafter MAL-PDT with OCT. After PDT 73.68% of treated lesions did not showsigns of residual tumor. This confirms the efficacy of PDT for BCC lesionswith limited infiltration depth.

Based on further studies, advices for pure non-invasive therapeutic proce-dures according to tumor thickness, subtypes of BCC and localizations couldbe given.

PDT of BCC monitored by Optical CoherenceTomography

Lutz SchmitzWuppertal, Germany

Lutz Schmitz, Christina Kellner, Uwe Reinhold, Frank Hevert, Thomas Dirschka

P2

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Key Words: BCC, Infiltration Depth, Non-Invasiv, Optical Coherence Tomography, PDT,Tumor Thickness

Objective: To compare the efficacy of fluorescence diagnosis as a non-in-vasive tool versus flow cytometric analysis of skin biopsies in follow-up ofpatients with mycosis fungoides (MF).

Methods: This study was carried out for 12 weeks on 25 patients receivingphototherapy. Each patient was subjected to fluorescence diagnosis of alesion followed by skin biopsy subjected to flow cytometric analysis, andrepeated after 12 weeks of phototherapy. Mann-Whitney and Wilcoxon testswere used.

Results: There was a significant decrease in the values of accumulationfactor (AF), the percent of CD4+ve/CD7-ve T-cells and the percent of thetotal count of T-cells (% gated) before and after therapy. When comparingthe clinical severity, degree of clinical response, results of fluorescencediagnosis and flow cytometry (FCM) to the stage of MF disease, no signi-ficant results were detected.

Conclusion: In early cases of MF, fluorescence diagnosis can represent aprognostic tool for evaluating the response to therapy.

Flow-cytometry versus fluorescencediagnosis as a prognostic tool for evaluatingthe response to therapy in early cases ofmycosis fungoides

Manal BosseilaCairo, EgyptM. Bosseila, F. Al-Helf, A. El-Sayed, D. Mahgoub, D. Metwally, M. El-Shaer

P1

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Key Words: CD4/CD7, Flowcytometry Fluorescence Diagnosis, Follow-up,Immunophenotyping, Mycosis Fungoides

The rise of resistance has rendered many antibiotics obsolete and with fewnovel antibiotics in the pipeline there is an increasing need for alterna-tives. This search for alternatives led to Antimicrobial Photodynamic The-rapy (APDT) which involves the use of light to activate Reactive OxygenSpecies producing drugs. The main drawback is that currently approvedsensitising drugs are activated by visible light which has limited penetra-tion through human tissue. This restricts PDT to the treatment of epithe-lial infections.

This project looks at using ultrasound to activate sonosensitisers therebyincreasing the penetration depth of the treatment and increasing the num-ber of infections that can be potentially targeted. In order to increase thistargeting the sonosensitiser drugs will be conjugated to various compoundsand nanoparticles. Protoporphyrin IX and Rose Bengal will be investigatedas potential sonosensitisers.

Antimicrobial Sonodynamic Therapy

David CostleyColeraine, Ireland

D. Costley, A.P. McHale, N.G. Ternan, J.F. Callan

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Key Words: Antimicrobial, Bacterial, Sonodynamic, Sonoluminescence

Daylight-mediated photodynamic therapy (DL-PDT) using methylaminolae-vulinate (MAL) is effective for thin actinic keratoses (AK).

This pilot study compared efficacy of BF-200 ALA with MAL in DL-PDT ofgrade I-III AKs.

177 AK symmetrically distributed in 13 patients randomized for a split-face prospective observer-blinded study, received BF-200 ALA or MAL DL-PDT. Grade I AKs were treated once and grade II-III AKs twice with0.25-mm layer of photosensitizers. Efficacy at 3 months was assessed cli-nically and histologically.

BF-200 ALA cleared 71/84 (84.5 %) and MAL 69/93 (74.2 %) of the AKs(p=0.099, Fisher’s exact test), all grades responding equally, but with newAK appearing during follow-up (n=4, BF-200 ALA; n=8, MAL). BF-200 ALA-and MAL-treatments resulted in 61.5% and 38.5% complete histologicalclearance (p=0.375, McNemar’s test). P53-expression reduced 54.4 % and33.7% respectively (p=0.522 Wilcoxon test). Treatments were nearly painless.

Minor but not significant difference was found referring BF-200 and MALas effective in DL-PDT.

Daylight-mediated PDT of AK: A randomizeddouble-blinded prospective study to compareBF-200 ALA with methyl-5-aminolaevulinate

Noora Neittaanmäki-PerttuHelsinki, FinlandNoora Neittaanmäki-Perttu, Toni Karppinen,Mari Grönroos, Taneli Tani, Erna Snellman

P3

59

Key Words: AK, BF-200 ALA, Daylight-mediated PDT, MAL, Histology, P-53 expression

A 82-year-old woman, with a large Bowen’s Disease on her right hand(tenar surface) was previously treated with 6 cycles of conventional-MAL-PDT and also with topical imiquimod by our PDT group. She always hadpartial response after all these procedures.

Since the lesion was superficial with no signs of microinvasion by histo-pathological analysis (another biopsy was taken), and as a surgical ap-proach could leave functional impairments, we decided for a non-surgicaltherapy.

Therefore, instead of conventional-PDT, she was submitted to an associa-tion of microneedling (MN) and PDT. After local anesthesia, MAL cream wasapplied over the lesion, followed by the microneedling, with a roller of2.0mm length needles. After 2 hours under occlusion, the area was irra-diated with red LED at 37J/cm2. A second session was carried out 15 dayslater, with the same method.

The erythema and pain after the procedure were intense and persisted for48 hours.

The outcome was considered excellent with complete clinical response. Al-though this is a case report with short follow up, the MN-assisted PDT forsuperficial Bowen´s Disease showed better response to conventional PDT.A longer follow-up is needed.

Difficult to treat Bowen’s disease on the handtreated with PDT and microneedling

Luis TorezanSao Paulo, Brazil

L. Torezan, B.M. Grinblat, J.A. Sanches Jr, L.P. Samorano, C. Festa-Neto

P6

62

Key Words: MAL, PDT, Microneedling, Bowen’s Disease

Topical photodynamic therapy (PDT) mediated with 5-aminolevulinic acid(ALA) offers an alternative option for the treatment of acne vulgaris. Thereare several studies with satisfactory results and different protocols of in-cubation times in PDT treatment. Scarring is a very common complicationin severe cystic acne patients.

Efficacy of 5-ALA PDT was assessed compared to standard isotretinointreatment.

The first group of ten patients with severe cystic acne received PDT withtopical 5% 5-ALA for one hour under occlusion and red light (LED Omnilux®633nm) once every 15 days and another group of ten patients receivedoral isotretinoin 1mg/kg b.w. for 16 weeks. Efficacy was evaluated withrespect to cure and response rate at 3 months following the end of treat-ment. Chemical abrasion preceeded the application of topical 5% 5-ALA inall cases. Results were satisfactory resulting in more than 50% reductionof inflammatory lesions by the end of the third treatment and significantlyimproved acne lesions at final assessment. Patients under PDT treatmenthad fewer side effects than patients under isotretinoin and similar impro-vement on skin texture changes such as pigment and scarring which wasretained up to 1 year post treatment.

The combination of low-dose ALA and a red light is a safe and effective op-tion for the treatment of moderate to severe acne.

PDT with topical 5% 5-ALA compared to oralisotretinoin in the treatment of severe facialinflammatory cystic acne

Evangelia PapadavidAthens, Greece

P5

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Key Words: PDT, Isotretinoin, Severe cystic acne

Phthalocyanines (Pcs) constitute a group of promising second generationphotosensitizers for photodynamic therapy (PDT). However, the applica-tion of Pcs is limited, due to their low solubility in aqueous solutions. Theaim of this study was to assess the cytotoxic activity and mechanism of ac-tion of new Pc (1,4-bis[2-(morpholin-4-ylo)ethoxy]phthalocyanine-TG3)substituted with morpholinyloethoxy groups in non-peripheral positionson prostate cancer cells in vitro. Our results showed that the TG3 possessesvery interesting photocytotoxic properties (low dark toxicity with high pho-todynamic activity IC50<0,5µM irradiation time: 20min, 0,2 W/cm2), andthus is a promising PDT candidate.

Noteworthy, it induces dose-dependent apoptosis at low, effective doses,increases the ROS production, but has a weak potential to induce oxidativeDNA damage.

This study was supported by the National Science Centre No.N401 067238(Poland) and the WTZ-Project Poland –Austria PL.20/2012

Biological activity of NEW non-peripherallysubstitued Phthalocyanine –in vitro evaluation for PDT

Malgorzata KucinskaPoznan, Poland

Malgorzata Kucinska, Wojciech Szczolko, Mariusz Kaczmarek, Tomasz Goslinski,Theresia Thalhammer, Marek Murias

P8

64

Key Words: 8-hydroxy-2'-deoxyguanosine apoptosis, Cancer cell lines,PDT, phthalocyanine, Reactive oxygen species

Several studies proved the efficacy of Daylight-PDT for AK and field can-cerization, and in all of them the efficacy was based on the clinical eva-luation.In this pilot study, we analyzed histologically the skin treated withDaylight-PDT.

Ten patients with multiple AKs, grades I and II on the face were selected.They were submitted to up to 02 Daylight PDT sessions (with 01 month in-terval) with MAL, following up the European Consensus of Daylight-PDT.

Two 4 mm- punch biopsies, from 2 different areas, one over an AK and theother on a appearing normal skin surrounded by AKs (field cancerization),were taken before and 3 months after the last treatment session. Histolo-gical parameters were: absence or persistence of AK lesion, degree and ex-tension of keratinocyte atypia and degree of solar elastosis.

All of the patients showed decrease of the number of lesions (mean rateof 86%) and all of them considered the treatment not painful.In all of the patients, the histological analysis showed absence of remainingAK lesion; decreased keratinocyte atypia in the field and also a normalepidermal polarization. We also observed a decrease of the elastotic materialin the field.

Although these are preliminary data, our results corroborate the clinicalefficacy of Daylight-PDT for AK and field cancerization. And compared tothe histological alterations induced by conventional-PDT, there is lessdermal impact with Daylight-PDT.

What´s behind the curtains?Preliminary histopathological results afterDaylight–PDT in Brazil

Beni GrinblatSao Paulo, Brazil

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Being less painful, daylight-mediated photodynamic therapy (DL-PDT) isfavored over the LED-PDT in the treatment of actinic keratoses (AK).This study assessed the efficacy and time consumption in DL-PDT andLED-PDT for cost-efficacy evaluation.70 patients with 210 AK were randomized to receive either LED-PDT or DL-PDT with methylaminolaevulinate. Grade I AK were treated once and gradeII-III twice. The time consumption of the nurse and patients, and painwere registered. The efficacy was assessed clinically at 6 months.

LED-PDT cleared 91/102 (89.2%) and DL-PDT 79/108 AKs (73.1%) referringLED-PDT significantly more efficient (p=0.005). Grades I-III respondedequally. DL-PDT required significantly less nurse’s (average 48.6 vs 73.6min, p=0.003) and patient’s time (228.4 vs 287.1, p<0.001) compared toLED-PDT. DL-PDT was less painful compared to LED-PDT, p<0.001.

The DL-PDT consumed less nurses time, which might lead to expensesavings. However, DL-PDT showed significantly lower clearance rates com-pared to LED-PDT.

PDT of AK: a randomized prospective studycomparing conventional anddaylight-mediated treatment to assessthe cost-efficacy

Noora Neittaanmäki-PerttuHelsinki, FinlandNoora Neittaanmäki-Perttu, Toni Karppinen, Mari Grönroos, Taneli Tani, Erna Snellman

P9

65

Key Words: AK, Conventional PDT, Cost-efficacy, Daylight-mediated PDT,MAL, Time-consumption

Background: Many studies highlighted predictive factors for PDT relatedpain. By modulating certain factors, a LED stimulation protocol wasdeveloped.

Objective: Demonstrate protocol effectiveness on frequently treatedlesions and in reduction of pain.

Method: LUXePro (Biolux Medical) associated with Metvixia® protocol (Gal-derma) was applied on 30 patients presenting non-melanoma skin cancerlesions. All patients were previously treated on similar lesion by PDT withother devices. They were followed for an adequate time to assess protocoleffectiveness and pictures were taken with FotoFinder system. Degree ofpatient related pain was assessed immediately after PDT on an increasingrating scale (0-10). The results’ analysis was performed using Student’s t-test and ANOVA.

Results:- Among the studied factors (size/type/location), only location influencespainful sensation- An average score (pain intensity) below 4 was observed in each group- More than 60% of patients reported reduced pain sensation- 80% of complete or quasi-complete remission at 4 months.This prospective study validates a simple approach to minimize painduring treatment.

Canwe reduce PDT related pain withoutaltering its effectiveness?

Mohsen AlirezaiMontpellier, France

M. Alirezai, M. Burland, J.M. Bec

Key Words: LUXePro, Painful-sensation, Protocol, PDT, Prospective

BACKROUND: Metvix® cream contains methyl aminolevulinate (MAL). Conven-tional Metvix® photodynamic therapy (PDT) has proved efficacious for thetreatment of certain types of actinic keratoses and basal cell carcinomas. Ho-wever, pain related to illumination during conventional Metvix®-PDT is a se-vere side effect. Replacing conventional PDT by natural daylight PDT mayrepresent a new strategy to reduce pain related to illumination. During expo-sure to daylight subjects are advised to utilize a sunscreen on non-treatedareas. However, sunscreen may change skin absorption of MAL, and thereforethe safety and efficacy of Metvix®. The main objective of this work was to eva-luate the interaction between sunscreen and Metvix® by evaluating the effectof sunscreen on MAL absorption in ex vivo human skin.METHODS: Freshly excised human skin samples from three different donors werefirstly treated with the sunscreen Cetaphil SPF30 Dermacontrol for 15 minutes.Afterwards, skin samples were treated with Metvix® cream containing [14C]-MAL for 2.5 hours at 37°C. Skin samples treated with Metvix® cream only wasused as control. At the end of incubation period, radioactivity was measuredin skin and receptor fluid samples.RESULTS: Mass balance values ranged between 91% and 115% in all skin samples(N=27). Moreover, the mean absorbed dose of [14C]-MAL was very low (0.007%- 0.010% of the applied dose) in all groups. The mean dose of [14C]-MALpenetrated into the skin was more than 20 times the absorbed dose. Fifteenminutes treatment with Cetaphil SPF30 Dermacontrol® had no statisticallysignificant effect on MAL skin absorption or distribution.CONCLUSION: No statistically significant effect of the sunscreen was seen on[14C]-MAL absorption and distribution in ex vivo human skin. This indicatesthat there was no significant interaction between the sunscreen and Metvix®in the in vitro conditions. Therefore, the sunscreen tested (Cetaphil SPF30Dermacontrol®) is unlikely to modify Metvix® safety and efficacy clinical profile.

Effect of sunscreen on Metvix® absorptionin ex vivo human skin

Hanan Osman-PonchetSophia-Antipolis, FranceHanan Osman-Ponchet, Karine Sevin, Alexandre Gaborit, Guy Bouvier,Pierre Comby, Bernard Ruty

P12

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Key Words: Cetaphil®, Ex vivo human skin, MAL, Metvix®-PDT, Sunscreen

P11

67

BACKROUND: Metvix®-photodynamic therapy (PDT) is a successful treatment for treatmentof certain types of actinic keratoses and basal cell carcinomas. Methyl-aminolevulinate,the active ingredient of Metvix®, is a prodrug that is metabolized to protoporphyrin IX(PpIX) which accumulates in the skin lesion. Light activation of accumulated porphyrinsleads to a photochemical reaction and thereby phototoxicity to the light-exposed targetcells. However, pain related to illumination during conventional Metvix®-PDT is a severeside effect. Replacing conventional PDT by daylight PDT may represent a new strategy toreduce pain related to illumination. Subjects are advised to protect the non-treated areaswith sunscreen. The choice of sunscreen is particularly important as physical filters wi-thin the sunscreen (such as Titanium or zinc oxide) may inhibit the absorption of visi-ble light which is necessary for PpIX activation. The main objective of this work was toinvestigate the effect of sunscreen on PpIX photobleaching in ex vivo human skin.METHODS: Freshly excised human skin samples were treated with PpIX solution in DMSO(100 µg/cm²) for 1 hour at 37°C, 5% CO2. To improve PpIX penetration, skin sampleswere dermarolled using MC410 dermaroller model prior to PpIX application. Sunscreen (Ce-taphil SPF30 Dermacontrol®) was then applied to skin surface (10µL/cm²). Control skinsamples were not treated with sunscreen. All samples were exposed to sunlight simula-tor (NDL) for 1 hour. Afterwards, PpIX concentrations in receptor fluid as well as in skinextract were analyzed by UV-Visible spectroscopy (300 to 800 nm).RESULTS: Exposure of ex vivo human skin samples treated with PpIX to solar simulatorinduced a 25% decrease in PpIX content in skin extract as compared to unexposed skinsamples. Moreover, treatment of skin samples with Cetaphil SPF30 Dermacontrol® priorto exposure to NDL had no statistically significant effect on PpIX content in skin ex-tract, indicating that there is no interaction between sunscreen and solar simulator.CONCLUSION: The sunscreen tested, Cetaphil SPF30 Dermacontrol®, had no statisticallysignificant effect on PpIX photobleaching in ex vivo human skin. This indicates that therewas no significant interaction between the sunscreen and solar simulator in the in vitroconditions. Therefore, this sunscreen is unlikely to modify Metvix® efficacy clinical profile.

Effect of sunscreen on Protoporphyrin IXphotobleaching in ex vivo human skin

Hanan Osman-PonchetSophia-Antipolis, France

Karine Sevin, Alexandre Gaborit, Guy Bouvier, Pierre Comby, Bernard Ruty,Hanan Osman-Ponchet

Key Words: Cetaphil®, Ex vivo human skin, Metvix®-PDT, PpIX, Sunscreen

A 77-years old man with multiple superficial basal cell carcinomas (BCC)on large areas of the scalp was treated with MAL-PDT and subsequent illu-mination with red light. After the 2nd illumination multiple milia occur-red, followed by tense blisters within the illuminated areas over the next6 weeks after the 2nd PDT course. Histology and direct immunofluores-cence analysis revealed the diagnosis of bullous pemphigoid (BP). Undertopical application of corticosteroids lesions cleared completely. Both BPand BCC did not recur within the last 18 months.

BP is an immune-mediated disease, the cause is not yet fully understood.Besides an association to internal malignancies it can be triggered bytrauma, burns, radiotherapy or UV-radiation. Is it therefore possible thatthe PDT-induced mechanical injury of the basement membrane may have in-duced autoantibody formation or, more likely, PDT has triggered local pre-cipitation of BP antibodies in this individual with pre-existing low titresof epidermal autoantibodies. So far this observation has been reportedonly once in the literature.

Bullous Pemphigoid triggered by MAL-PDT

Daniela StaufferArlesheim, Switzerland

P14

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Key Words: BCC, PDT, Bullous pemphigoid, Adverse event

P13

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Photodynamic therapy (PDT) is not always effective in the treatment ofnonmelanoma skin cancer and resistant cell populations may appear. PDToptimization and new therapeutic approaches which, combined, achievingtumor eradication are under investigation. In this respect agents capableof inducing cell differentiation like calcitriol, the hormonally active formof vitamin D3, are being studied. We have evaluated the effect of calcitrioltreatment on different SCC cell lines, sensitive (SCC-P) and resistant (SCC-10ºG) to MAL-PDT to determine whether calcitriol enhances the effect ofPDT. Our results confirm the pro-differentiating and antiproliferativeactivities of supraphysiological non toxic concentrations of calcitriol inthe SCC cells. The expression patterns of the adhesion E-cadherin and β-catenin were not altered. However, a decrease in the percentage of cellspositive p-Survivin, a molecule implicated in cell survival, was observedwhen calcitriol was added. The protoporphyrin IX levels as well as thephototoxic effect of PDT was enhanced, both in sensitive and resistant celllines, when cells were pretreated with calcitriol. Our results indicate apositive effect of calcitriol on the cellular resistance to MAL-PDT.

The response of resistant SCCs to PDTis enhanced by vitamin D3

Angeles JuarranzMadrid, Spain

Omar Kourani, Yolanda Gilaberte, Nerea Salazar, Alejandra Damian, Silvia Lucena,Alicia Zamarrón, Francisco Sanz-Rodríguez, Salvador González, Angeles Juarranz

Key Words: PDT, SCC, Therapy resistance, Calcitriol

Awards for best oraland poster presentations

� Awards for best posters

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� Awards for best oral presentations

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