THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY

15TH ANNUAL CONGRESS THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY Friday, February 12th Saturday, February 13th, 2016 Barcelona, Spain Program w w ...
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15TH ANNUAL CONGRESS

THE EUROPEAN SOCIETY FOR PHOTODYNAMIC THERAPY Friday, February 12th Saturday, February 13th, 2016 Barcelona, Spain Program

w w w.euro-pdt .org Platinum sponsor

MEETING ORGANIZATION Congress President Y. Gilaberte, Huesca, Spain Board of the Euro-PDT L.R. Braathen, Bern, Switzerland R.-M. Szeimies, Recklinghausen, Germany A. Sidoroff, Innsbruck, Austria C.A. Morton, Stirling, Scotland Scientific committee L.R. Braathen, Bern, Switzerland R.-M. Szeimies, Recklinghausen, Germany A. Sidoroff, Innsbruck, Austria C.A. Morton, Stirling, Scotland N. Basset-Séguin, Paris, France M.J.P. Gerritsen, Nijmegen, The Netherlands Y. Gilaberte, Huesca, Spain P. Calzavara-Pinton, Brescia, Italy H.C. Wulf, Copenhagen, Denmark A.-M. Wennberg, Gothenburg, Sweden R.E. Hunger, Bern, Switzerland Local Scientific Committee Y. Gilaberte, Huesca, Spain A. Toll, Barcelona, Spain C. Guillen, Valencia, Spain S. Nonell, Barcelona, Spain Congress secretariat and hotel reservation VISTA - EURO-PDT 2016 24 rue Erlanger - 75016 Paris Tel. : +33 (0)1 46 43 33 42 Fax : +33 (0)1 46 24 88 38 Email : [email protected] Congress venue AC Barcelona Forum Hotel Paseo Taulat 278 Barcelona, Spain

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Welcome to the 15th Annual Congress of the European Society for Photodynamic Therapy in Dermatology, EURO-PDT, the world’s largest congress devoted to research and clinical use of PDT in Dermatology. PDT is a well established successful method for treatment of non-melanoma skin cancer. It is furthermore documented as successful for other indications, for example ; acne, skin rejuvenation,various skin infections, skin lymphomas and other dermatological disorders. With the introduction of the innovative DL-PDT the PDT procedure is simplified without loss of clinical efficacy. The speakers present the latest hottest news of their research and I am convinced that we will learn a lot about new developments of PDT. Of course you also have a unique opportunity to discuss the research results and the new developments with your colleagues. Welcome to Barcelona

Prof. Lasse R. Braathen President of EURO-PDT 3

Dear colleagues, On behalf of the local Organizing Committee, it is my great pleasure to welcome you to the 15th Congress of the European Society of Photodynamic Therapy in Barcelona. Following the tradition of previous congresses, this meeting has been designed to be an update of the last progress and developments in the field of PDT for dermatologists. Each Euro-PDT meeting offers researchers and clinicians from different countries an excellent opportunity not only to learn but also to interact and exchange knowledge and experiences in the field of PDT. We are certain that Barcelona will be a magnificent location to host such a high level meeting, with its two thousand year of history reflected in monuments, streets and museums and with its current modern, cosmopolitan and Mediterranean environment. We hope that the scientific program fulfils your expectations and that the congress provides you a good opportunity to meet old colleagues and make new friends, all of this in a charming atmosphere that the beautiful city of Barcelona offers to visitors. Looking forward to welcoming you to Barcelona.

Yolanda Gilaberte Congress President 5

15TH Annual Congress Barcelona, Spain Friday, 12th February 2016

14:00

Introduction Lasse Braathen & Yolanda Gilaberte Welcome and PDT guidelines Lasse R. Braathen, Switzerland

Plenary session I: Epidemiology, Diagnosis & Consensus Lasse Braathen & Peter Wolf 14:10

Prevalence and risk factors of AK in Italian Dermatology outpatients Maria Concetta Fargnoli, Italy................................................................C1

14:20

Thin AK lesions with atypical basal cells are just as dangerous as thick ones Maite Fernández-Figueras, Spain..........................................................C2

14:30

PDT resistance factors in NMSC Angeles Juarranz, Spain .......................................................................C3

14:40

Structured expert consensus on AK: up-to-date treatment algorithm Piergiacomo Calzavara Pinton, Italy ......................................................C4

Plenary session II: AK Lesion versus field therapy Skin preparation Sally Ibbotson & Celeste Brito

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14:50

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

15:00

Retrospective analysis comparing the impact of keratolytic or physical pretreatment on the efficacy and safety of PDT for AK with Methylaminolaevulinate (MAL) Patrick Gholam, Germany .....................................................................C6

15:10

Physical pretreatment regimens to enhance PpIX uptake and PDT reactions in normal skin Merete Haedersdal, Denmark...............................................................C7

15TH Annual Congress Barcelona, Spain Friday, 12th February 2016

15:20

Microneedling assisted DL PDT for AK Martina Hund, Germany .......................................................................C8

15:30

Multi-modal therapy approaches in PDT Peter Arne Gerber, Germany ................................................................C9

15:40

Break and poster session

Plenary session III: Efficacy data Merete Haedersdal & Claas Ulrich 16:10

Potential impact of patient vitamin D status in AK response to MAL-PDT Luis Torezan, Brazil .............................................................................C10

16:20

Ingenol mebutate vs PDT in AK patients Maria Teresa Rossi, Italy ......................................................................C11

16:30

Histologic AK dysplasia has no relation to AK thickness - consequences for treatment Ida Heerfordt, Denmark......................................................................C12

16:40

One week of 5-FU followed by DL-PDT: a combination study Christopher Nissen, Denmark .............................................................C13

16:50

Bucher’s indirect comparison of different treatments for multiple AK Rolf-Markus Szeimies, Germany .........................................................C14

17:00

DL PDT for AK: high maintenance of clearance at one year Maria Concetta Fargnoli, Italy .............................................................C15

17:10

DL PDT for AK : histologic assessment of efficacy Beni Grinblat, Brazil ............................................................................C16

17:20

Retrospective analysis of DL-PDT and cPDT in AK with 3D imaging Carmen Cantisani, Italy .......................................................................C17 7

15TH Annual Congress Barcelona, Spain Friday, 12th February 2016

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

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17:30

Practical approach to the use of DL-PDT with topical methyl aminolevulinate for AK: a European consensus Colin Morton, UK ................................................................................C18

17:40

DL-PDT vs blue light cPDT for AK Christophe Bedane, France ................................................................C19

17:50

DL-PDT can be administered within the usual consultation duration Ana Julia García-Malinis, Spain ..........................................................C20

18:00

DL-PDT: handling a safe and simple protocol Jacques Savary, France.......................................................................C21

18:10

DL-PDT experience in Dundee Sally Ibbotson, UK..............................................................................C22

18:20

One year experience of DL-PDT in Belgium Muriel Creusot, Belgium .....................................................................C23

18:30

PDT in Sassuolo, Modena: present practice and future plans Marco Curci, Italy ...............................................................................C24

18:40

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

18:50

DL-PDT experience in Padova Stefano Piaserico, Italy .......................................................................C26

15TH Annual Congress Barcelona, Spain Saturday, 13th February 2016

Plenary session V: AK Prevention Ann-Marie Wennberg & Colin Morton 09:00

Occupational skin cancer and prevention Claas Ulrich, Germany ........................................................................C27

09:10

Primary Prevention of Skin Dysplasia in Renal Transplant Recipients With PDT: A Randomized Controlled Trial Katryn Togsverd-Bo, Denmark ............................................................C28

Plenary session VI: BCC 09:20

Fractional laser-mediated PDT of high-risk BCC-a randomized clinical trial. Uwe Paasch, Germany .......................................................................C29

09:30

10 years of PDT experience for AK and BCC in Portugal Celeste Brito, Portugal ........................................................................C30

Plenary session VII: Skin rejuvenation and other indications Rolf-Markus Szeimies & Hans-Christian Wulf 09:40

New approaches to antimicrobial photodynamic therapy Santi Nonell, Spain.............................................................................C31

09:50

MAL PDT for onychomycosis: a multicenter, randomized, controlled, clinical trial Yolanda Gilaberte, Spain ...................................................................C32

10:00

Break and poster session

10:30

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

10:40

Aesthetic indications for PDT Matteo Tretti Clementoni, Italy ...........................................................C34 9

15TH Annual Congress Barcelona, Spain Saturday, 13th February 2016

10:50

Management of post-treatment erythema Peter Arne Gerber, Germany ..............................................................C35

11:00

Scalp nerve blocks for pain management during large field PDT Sigrid Karrer, Germany........................................................................C36

11:10

DL-PDT with MAL in the treatment of actinic cheilitis Dario Fai, Italy .....................................................................................C37

11:20

Cutaneous leishmaniasis responds to DL-PDT: proof of concept for a novel self-administered therapeutic modality Claes D. Enk, Israel..............................................................................C38

11:30

PDT for acne Ann-Marie Wennberg, Sweden .........................................................C39

11:40

Poster communication Lasse Braathen & Rolf-Markus Szeimies

11:50

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End and awards

ABSTRACTS Glossary AK ..........Actinic Keratosis ALA ........Aminolevulinic Acid BCC.........Basal Cell Carcinoma nBCC.......Nodular BCC sBCC .......Superficial BCC CR...........Complete response Fx ...........Fractional DL-PDT ....Daylight PDT

LED .........Light-Emitting Diode MAL........Methyl Aminolevulinate NMSC......Non-Melanoma Skin Cancer PDT .........Photodynamic Therapy PpIX........Protoporphyrin IX SCC.........Squamous Cell Carcinoma SD...........Standard Deviation VAS.........Visual Analogic Scale

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Prevalence and risk factors of AK in italian dermatology outpatients Maria Concetta Fargnoli L’Aquila, Italy E. Benati, F. Borgia, A. Carbone, S. Chimenti, L. Donato, E. Frigerio, E. Moggio, P. Broganelli, G. Girolomoni, G. Micali, A. Parodi, S. Piaserico, G. Pistone, C. Potenza, M. Puviani, M. Raucci, S. Vaccari, S. Veglio, A. Zanca, K. Peris

Aim of the study was to assess AK prevalence and risk factors in patients aged ≥30 years attending 24 Italian dermatology outpatient clinics. Prevalence of AK was assessed in the whole study population. Risk factors were evaluated in patients with available data for all the variables of interest, after redefining AK to include both current lesions and a history of AK. The study population included 8461 patients, of which 7284 were included in the analysis of prevalence. The prevalence of AK in dermatology outpatients was 27.4% (95% confidence interval, 26.4–28.4%), with 34.3% in males and 20.0% in females (p 6 hours/day (OR 1.9), male gender (OR 1.7), face solar lentigos (OR 1.6), light hair (OR 1.5), prolonged recreational outdoor activities (OR 1.4), light eyes (OR 1.3), skin phototype I/II (OR 1.3), and alcohol consumption (OR 1.2). BMI ≥25.0 (OR 0.6), regular sunscreen use (OR 0.7), and lower educational level (OR 0.8) were independent protective factors. The prevalence of AK was high in Italian dermatology outpatients. We confirmed several well-known AK risk factors and revealed possible novel risk and protective factors for AK.

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Key Words: AK, Prevalence, Risk factors, Outpatients

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Thin AK lesions with atypical basal cells are just as dangerous as thick ones María Teresa Fernández Figueras Badalona, Spain

All actinic keratoses (AK) start with atypical transformation of the basal layer. Eventually, some regress whereas others transform into invasive squamous cell carcinoma (iSCC). This was considered to occur only following complete transformation of the epidermis through three stages, akin to the “classic pathway” in HPV-associated iSCC. Accordingly, only thick and hyperkeratotic lesions would be high-risk lesions, a final stage before iSCC development. After evaluation of 196 consecutive biopsy specimens, we demonstrated that in most cases iSCC arises directly from AK with dysplasia limited to the basal layer, akin to the “differentiated pathway” in iSCC of the vulva and oral mucosa. Extension of basal dysplasia along the follicular epithelium was also common and often the origin of iSCC. Thus, clinically thin lesions can no longer be considered as low risk. Furthermore, direct transformation from the cancer field -also characterized by basal dysplasia- cannot be ruled out.

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Resistance to photodynamic therapy in non-melanoma skin cancer Ángeles Juarranz Madrid, Spain Y. Gilaberte, S. González, E. Morel, A. Zamarrón

One of the problems of PDT, as well as other cancer therapies, is the persistence of some tumors after treatment. We have selected resistant cells from squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) cell lines by repeated MALPDT treatments in order to evaluate factors implicated in a reduced response to PDT. Resistant cells present a more fibroblastic morphology, higher expression of cell-substrate adhesion proteins and higher ability to induce tumors in immunodeficiency mice. The evaluation of potential genes implicated in a decreased response of SCC to MAL-PDT reveals genomic imbalances in CCND1, EFGR and MAP3K1 genes. Our group has observed that some SCC resistant to MAL-PDT have also an altered expression pattern of such genes. As a conclusion, we can suggest that the MAPK pathway could be implicated in a decreased response to PDT. A combination of PDT with some other therapies that specifically target genes implicated in a decreased response to PDT could allow us to overcome the resistance.

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

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Structured expert consensus on AK: up-to-date treatment algorithm Piergiacomo Calzavara-Pinton Brescia, Italy

Clinical guidelines for the management of AK need to be regularly updated as new treatments become available. A systematic review of AK clinical guidelines was conducted. This informed the preparation of a three-round Delphi panel followed by a consensus meeting, which combined opinions from 16 experts in 13 countries. We found gaps in current guidelines with respect to new AK treatments such as ingenol mebutate and daylight PDT. The Delphi panel established consensus statements across diagnosis, definition, classification and management of AK. While the diagnosis of AK essentially rests on the nature of lesions, treatment decisions are based on several clinical and non-clinical patient factors and diverse environmental attributes. Participants agreed on distinguishing AK as three categories: isolated AK lesions requiring lesion-directed treatment; multiple lesions on a small field; multiple lesions on a large field, both requiring specific treatment approaches. A treatment algorithm was developed which accounted for approved treatments.

Key Words: PDT, methylaminolevulinate, AK

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C5

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

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

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

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The impact of keratolytic or physical pretreatment on PDT Patrick Gholam Heidelberg, Germany C. Fink, I. Bosselmann, A. Enk

PDT is a highly effective treatment option for actinic keratosis (AK). As hyperkeratosis of the AK impairs penetration of the photosensitizer and light a pretreatment is necessary. This retrospective study compares the effects of the recommended curettage (CUR), chemical keratolytic pretreatment with salicylic acid 10%(SA), and urea cream 40%(UR) on the efficacy and tolerability of PDT. A total of 44 subjects with multiple AKs in face and scalp were analysed. In 15 patients, CUR was performed prior to PDT while 15 and 14 patients underwent keratolytic pretreatment with SA and UR, respectively, one day prior to PDT. All patients underwent one session of MAL-PDT using a 630-nm LED lamp at 37J/cm2. Mean lesion response rates were 68.5%, 61.4% and 60.8% for CUR, SA and UR respectively. Differences were not significant. Patients with SA or UR experienced significantly more pain than patients with curettage (6.3, 6.1 vs. 4.4). The cosmetic result and the patients' satisfaction 4 weeks after PDT were good to excellent in all three groups. However, pretreatment with SA or UR led to pronounced local reactions compared to CUR. CONCLUSION: Keratolytic therapy with SA or UR is an effective pretreatment for PDT. However, it leads to an increase in pain during PDT and pronounced local reactions.

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

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Physical pretreatment regimens to enhance PpIX uptake and PDT reactions in normal skin Merete Haedersdal Copenhagen, Denmark C. Bay, C.M. Lerche, B. Ferrick, P.A. Philipsen, K. Togsverd-Bo

Pretreatment of the skin is essential for adequate penetration of topical photosensitizing agents and subsequent protoporphyrin IX (PpIX) accumulation. We aimed to compare the potential of different physical pretreatments to enhance PpIX fluorescence in photodynamic therapy (PDT). Healthy volunteers were each exposed to standardized skin preparation with curettage (CU), microdermabrasion (MD) with abrasive pads, microneedling (MN) with dermarollers, ablative fractional laser (AFXL) and non-ablative fractional laser (NAFXL), followed by 3 hours of methyl-aminolevulinate (MAL) (Metvix) incubation and subsequent red light illumination. Histology confirmed standardization of interventions. Data will be shown on PpIX fluorescence accumulation, photobleaching and local skin reactions.

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

C8

Microneedling-assisted DL-PDT for Treatment of AK Martina Hund Berlin, Germany

Introduction: DL-PDT has been shown to be as effective as and less painful than conventional PDT in the therapy of actinic keratosis. Several different pre-treatment regimens have been reported to increase the efficacy of DL-PDT by improving intraepidermal penetration of the photosensitizer. One of these pre-treatment options is microneedling of the skin directly after application of the sensitizer. Methods: Case series (n=2) from our private dermatological clinic. Patients were asked to apply a chemical sunscreen (SPF 50+) in the morning at home or at the latest 20 minutes before coming into our office. In our office, the photosensitizer was applied covering the actinic keratosis, directly followed by microneedling with a 0.5mm needler. Patients were instructed to expose the treatment area to daylight for 2 hours, then to remove the sensitizer and to stay indoors. Patients were followed-up in our office during the healing period as well as after 6 weeks after treatment for evaluation of therapy efficacy. Results: We present patients who were treated with microneedling-assisted DL-PDT for actinic keratosis. Patients reported an uncomfortable temporary burning sensation while needling the skin after application of the sensitizer and showed a severe phototoxic reaction after the daylight sun exposure. High percentage of actinic keratosis cleared after the intervention, mottled pigmentation faded with time and the skin structure improved. Patients were very satisfied with the results and willing to undergo further treatment cycles with DL-PDT if necessary. Discussion: In our experience microneedling-assisted DL-PDT is a highly effective and well tolerated treatment option in actinic keratosis including an aesthetic improvement of the skin structure especially in sun damaged skin. As the procedure of needling is uncomfortable and the subsequent phototoxic reaction may be very severe detailed patient education and post-treatment surveillance is required to obtain best treatment results and satisfied patients.

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C9

Multi-modal therapy approaches in PDT Peter Arne Gerber Duesseldorf, Germany S. A. Braun, J.-M. Baron

Recently different strategies have been used to improve the efficacy or reduce the adverse effects of conventional or standard photodynamic therapy (PDT). A very succesfull approach is the promotion of the uptake of 5-aminolevulinic acid (5ALA) or methyl aminolevulinate (MAL) to increase the bioavailability of the photosensitizers. Here, we demonstrate in a novel in vitro human full-thickness 3D-skin equivalent of actinic field cancerization that pre-treatment with ablative fractional lasers (AFXL) followed by application of MAL results in singificantly increased levels of protoporphyrin IX (PPIX) and cytotoxicity in dysplastic epithelial cells after irradiation with 632 nm red light-emitting diode (LED) lamps. Results were evaluated using the Mann-Whitney U test. In vivo proof-of-principle analyses demonstrate increased levels of PPIX and stronger inflammatory reactions for AFXL- and micro-needling-assisted MAL-PDT as compared to conventional PDT. Herein, application of MAL followed by micro-needling is more efficiant as compared to micro-needling followed by MAL.

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

C10

Potential impact of patient vitamin D status in AK response to MAL-PDT Luis Torezan Sao Paulo, Brazil B. Grinblat, N. Valente, R.M. Szeimies, M. Haedersdal

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

Key Words: Calcipotriol, MAL, PDT, AK

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Ingenol Mebutate versus cMAL-PDT: an intrapatient side to side comparative study Mariateresa Rossi Brescia, Italy C. Zane, M. Arisi, P. Calzavara-Pinton

PDT with methyl aminolevulinate (MAL-PDT) and topical treatment with ingenol mebutate gel (IMB) are approved therapeutic options for patients with multiple actinic keratoses (AKs). We performed a comparative, intra-patient, side-to-side, randomized clinical trial to compare treatment outcomes of MAL-PDT and IMB. Two symmetrical contralateral areas of about 25 cm2 harboring a similar (≥4) number of AKs were selected and randomly assigned to be treated with IMB for 3 days or one session of MAL-PDT. Forty patients with a total of 404 AKs were enrolled. The lesion complete response (CR) rates at 3 months were 61.8 % with IMB and 66.4 % with MAL-PDT (p=NS). Pain was higher with PDT but local skin reaction was more severe and time to healing was longer with IMB. The cosmetic outcome was rated as good or excellent in all treated patients with both drugs.

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Key Words: AK, Ingenol mebutate, MAL, PDT

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Histologic AK dysplasia has no relation to AK thickness - consequences for treatment Ida M. Heerfordt Copenhagen, Denmark C.V. Nissen, T. Poulsen, P.A. Philipsen, H.C. Wulf

Background: It is assumed that thick actinic keratoses (AK) are more dysplastic than thin lesions. However, this correlation has never been demonstrated. We investigated if measured thickness of AK correlates with dysplasia. Methods: Sixty-six AKs were examined. Prior to performing a punch biopsy, the thickness of each AK was measured using scale bars with thickness of 0.5 mm and 1 mm. Subsequently, the thickness of the stratum corneum and the degree of dysplasia were assessed histologically. Data were analyzed with Spearman’s test. Results: The histological thickness of the stratum corneum increased significantly with measured AK thickness (p=3·10-10). However, neither measured thickness (p=0.69) nor histological thickness of the stratum corneum (p=0.10) was correlated to the degree of dysplasia. Conclusion: Thin AKs show the same severity of dysplasia as thicker lesions. Our findings suggest that all AK lesions independent of thickness must be treated.

Key Words: AK dysplasia, AK thickness

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One week of 5-FU followed by daylight-PDT of actinic keratosis: a combination study Christoffer Nissen Copenhagen, Denmark S.R. Wiegell, I.M. Heerfordt, C.S. Mikkelsen, H.C. Wulf

Background Treatment efficacy for photodynamic therapy (PDT) is reduced when treating actinic keratosis (AK) on the extremities in comparison to the face and scalp. We investigated if sequential treatment with 5-fluorouracil cream (5-FU) and daylight-PDT would enhance treatment response of AKs on the hands. Methods Nineteen patients with multiple AKs on the dorsal aspects of both hands were treated with methyl aminolevulinate (MAL) daylight-PDT. One hand was randomly allocated to 7 days of pretreatment with 5% 5-FU cream twice daily before daylight-PDT, while the other hand was not pretreated. Treatment efficacy was evaluated after 3 months. Data were analysed using the Wilcoxon test. Results We treated 654 AKs (grade I: 197, grade II: 352, grade III: 105). The overall clearance rate was significantly higher for 5-FU/daylight-PDT than for daylight-PDT (58% vs 46%, P=0.0001). Conclusion Combining 5-FU and daylight-PDT is an effective way to enhance treatment efficacy of AKs on the hands.

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

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Bucher’s indirect comparison of DL-PDT with MAL cream versus diclofenac plus hyaluronic acid gel for the treatment of multiple AK Rolf-Markus Szeimies Recklinghausen, Germany P.G. Calzavara-Pinton, C. Zane, M. Pacou

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

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

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DL-PDT for AK: high maintenance of clearance at one year Maria Concetta Fargnoli L’Aquila, Italy A. Piccioni, L. Neri, S. Tambone, C. Pellegrini, K. Peris

Objective of the study was to assess the 12-month efficacy and safety of DL-PDT versus c-PDT in the treatment of face/scalp AKs in 34 patients from a previous intra-individual trial. Recurrence rate and clearance rate were assessed 12 months after a single PDT session. The 12-month recurrence rate of AKs cleared at 3 months was 13% after DL-PDT and 10% after c-PDT, with no statistical difference (p=0.16). For AK I, recurrence rate was 8% after c-PDT and 11% after DL-PDT (p=0.21). The 12-month clearance rate of baseline AKs was higher for c-PDT (76%) than DL-PDT (66%) (p 20 sunscreen should be applied to all sun-exposed areas usually 15 minutes before skin preparation. MAL cream is then applied, without need for occlusion, with daylight exposure to follow within 30 minutes. After 2 hours daylight exposure MAL cream should be washed off and the treated area protected from the sun for the rest of the day.

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Split face comparison of Daylight versus Blue light-PDT for the treatment of facial AK Christophe Bedane Limoges, France S. Assikar, S. Leobon, I.O. Matei, N. Souyri, A. Couraud

DL-PDT is more and more used as first line treatment for facial AK. The aim of the present study was to compare the efficacy and tolerance of D-PDT to a standart Blue light PDT. 26 patients harbouring grade I to II AK were randomly assigned to receive D-PDT on one side of the face and scalp and blue light PDT on the other side. Daylight intensity was recorded with a portable device. The mean number of AK was 23,1 on the C-PDT side versus 22 ,6 on the D-PDT side. The response rate at one month was 93% for C-PDT vs 89% for D-PDT. At three months the response rate was 96,6% vs 90% (p=0,18) and at six months 94% vs 91% (NS). At six months the mean number of new AK was 1,3 for C-PDT vs 2 for D-PDT Pain evaluation by analogic scale was 7 for blue light and 2 for Daylight PDT (p=0,0077). The present study confirms that D-PDT is equivalent to C-PDT for the cure rate of grade I and II AK. The great advantage of daylight-PDT is the considerable decrease of pain.

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Key Words: PDT, AK , DL-PDT

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DL-PDT can be administered within the usual consultation duration Ana Julia García-Malinis Huesca, Spain A.J. García-Malinis, O. Callen García, P. Frías, Y. Gilaberte

Background Conventional photodynamic therapy (c-PDT) is a widely used for treatment actinic keratosis (AK). Daylight photodynamic therapy (DL-PDT) has been shown to be similar to c-PDT in the treatment of AK, better tolerated and nearly painless with high patient satisfaction. Compared with topical treatments for AK, DL-PDT is more time consuming for dermatologists, which could be a drawback to prescribe it in clinical practice. Aim Evaluate the average time spent by the dermatologist to prepare a patient for DLPDT. Material and methods An observational prospective including all the patients diagnosed with AK in the Units of Dermatology of San Jorge Hospital and Jaca Hospital (Spain) from February to June 2015. Time spent for curettage and application of MAL was collected in minutes. Results Fifty patients were included in the study. The mean of the time was approximately 6 minutes (range 3-10 minutes). The most common treated areas were face (n=38, 76%) followed by scalp (n=32, 64%). The average time in both locations was five minutes, with a range of 3-7 minutes and 3-8 minutes, respectively. Conclusions DL-PDT is a simple procedure for the treatment field cancerization and AK, that can be easily performed in routine clinical practice.

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

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DL-PDT: handling a safe and simple protocol Jacques Savary Paris, France

• Make an appointment for the treatment: - Curettage - Cream application • Choose an ad hoc schedule depending on the month, the geographical position of the place • Prescription: - Uréa cream 30%: 1 application in the evening during one week, to start one week before the appointment - MAL cream - Actinica lotion - Don’t forget to bring a cap or a hat • The D day: Two possibilities - Sunny day or no risk of rain:cream application by the doctor: • Actinica application on all the face, the scalp, the hands • Curettage : very smooth thanks to the urea cream • Metvixia application with one finger - Rainy day: Treatment impossible today • Curettage : very smooth thanks to the urea cream • Explanations to the patient (or third person) how to apply Actinica first and Metvixia after: • Topography • Quantity of both products • When to follow the treatment? • Application of Metvixia the first non rainy day within the next week • Then exposure to daylight within 30mn after the application of Metvixia go outside and stay there for 2 hours - What happens after treatment? • Your skin will be red during one or two days and then scaly for 10 days • Be careful with the sun on the following day • Make an appointment within 3 months

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C22

DL-PDT experience in Dundee Sally Ibbotson Dundee, UK

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

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

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C23

DL-PDT: One year experience in Belgium: How to organize the pratice to optimize treatment Muriel Creusot Genappe, Belgium

Introduction DL-PDT is a new alternative method for KA treatment and field cancerization. The aim of this observation is to evaluate the number of patients eligible for this treatment. Material and methods Between March and October 2015: 110 patients treated by DL-PDT versus 320 by C-PDT. Discussion C-PDt is refunded in Belgium only in hospital, Metvix® being issued by the hospital pharmacy. Our medical center pratice c-PDT for 12 years. Working place is in countryside south of Brussels, where patients access DL-PDT easily. Organization requires flexibity: when bad weather, patients can postpone treatment, or switch to C-PDT. For being effective, treatment requires strict respect of the procedure, requiring to explain carefully and educate the patient. Conclusion DL-PDT is an interisting alternative to c-PDT even in Belgium • less time, less painful • lower cost (less cream, different coding than c-PDT) • enpower the patient.

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

C24

PDT in Sassuolo, Modena: present practice and future plans Marco Curci Sassuolo, Italy

Sassuolo is a small town located in Northern Italy with a population of approximately 40000 inhabitants. Sassuolo hospital is equally small, however, since 2009, it has enjoyed a dedicated Dermatology Department providing general dermatological care but with a special interest in Dermatological Surgery and Dermato-Oncology. In order to supplement its therapeutic offer for oncology patients, our Department has been performing "classic" PDT for 3 years by now. So far, we have treated over 500 patients per year with clearance rates at 3 months for AKs, superficial BCCs and Bowen diseases equal to 90%, 95% and 90% respectively. Recently, our Department has been selected as the only Dermatology Department in our region, Emilia-Romagna, to participate in the SESAME study focused on Daylight PDT; for this purpose, we are currently organizing a special area outside our hospital which will be specifically dedicated to Daylight PDT sessions.

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

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C25

Can DL-PDT work indoors ? Hans Christian Wulf Copenhagen, Denmark I.M. Heerfordt, J. Heydenreich, C.M. Lerche

Background: DL-PDT has been adopted as a convenient, painless way of performing PDT. However, the use is limited due to rainy or cold weather, and an indoor illumination source is needed which can act as a substitute for daylight. Material: We investigated the use of the following lamp types: slide projector, overhead projector, white LED, red LED panel, Aktilite, and natural daylight in a greenhouse. Method: The PpIX weighted fluence rate was calculated for all lamps. The fluence rate to prevent any build-up of PpIX in test persons during 2 hours of illumination was determined. Results: Generally, 5000 lux was sufficient for complete activation of PpIX, except for white LED that needed 12.000 lux to be as efficient. In the greenhouse there will practically always be sufficient daylight, and the glass prevents sunburn. Conclusion: Most lamps may be used although the efficacy will depend on the spectral distribution.

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

C26

DL-PDT experience in Padova Stefano Piaserico Padova, Italy

Daylight PDT (DL-PDT) is a novel PDT modality in which the activation of the topical photosensitizer is induced by the exposure to natural daylight instead of artificial light sources without requiring preliminary occlusion. An ever-increasing body of evidence supports the effectiveness and tolerability of DL-PDT with MAL for the treatment of actinic keratoses, highlighting that this approach can be considered an effective, safe and convenient alternative for the treatment of facial/scalp lesions, especially for the thin lesions. These findings were corroborated by the results of two Phase III studies in Australia and Europe. Overall, the procedure is perceived as less painful by the patients. Morover, larger areas of sun damage can be treated on a single occasion. In Italy, DL-PDT has been recently approved for the treatment of actinic keratosis. We will report on our experience both in a private and in a University setting. We will also try to give some suggestion on off label use of DL-PDT (namely in the treatment of actinic cheilitis, flat warts, sebopsoriasis).

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C27

Occupational skin cancer and prevention Claas Ulrich Berlin, Germany

Coal tar, soot and polycyclic aromatic hydrocarbons are listed in the International Agency for Research on Cancer Group I list, indicating them being acknowledged as “Carcinogenic to humans” since decades. In 2009, UVR was added to this Group I list of the most established carcinogens. According to the European CAREX (CARcinogen EXposure) database, established with support from the Europe Against Cancer Programme of the European Union, within the EU at least 9.1 million workers are regularly exposed to solar radiation during at least 75% of their working time. There is sound evidence that workers at various workplaces across Europe, being exposed to intense levels of UVR, develop a much higher incidence of non-melanoma skin cancer. Thus, the development of skin cancer screening algorithms for outdoor-workers, raising awareness for the impact of natural UVR on the induction and promotion of non-melanoma skin cancer in outdoor workers by dissemination of information material on occupational skin cancer to health care policy-makers, employers and outdoor workers as well as the evaluation of impact of preventive measures such as suitable textile photo-protection, appropriate sunscreens and sun-smart behaviour on the development of work-related skin cancer have to be considered.

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Key Words: Outdoor-workers, Skin cancer, Prevention

C28

Primary prevention of skin dysplasia in renal transplant recipients with PDT: A randomized controlled trial Katrine Togsverd-Bo Copenhagen, Denmark S. Haukali Omland, H.C. Wulf, S. Schwartz Sørensen, M. Hædersdal

Prevention of squamous cell carcinoma (SCC) in organ transplant recipients (OTRs) includes early treatment of actinic keratosis (AK). We investigated the effect of repeated PDT for primary prophylaxis of skin dysplasia. These data represent an interim analysis of an on-going randomized controlled trial. Renal transplant recipients (n:25) with normal skin were randomized to split-side PDT of the face, forearm and hand, the contralateral side serving as untreated control. Patients received PDT on inclusion and at 6-monthly intervals for 5 years. We found that prophylactic PDT significantly delayed onset of AK compared with untreated skin, p=0.020. At 3-years follow-up, 63% of patients had AKs in untreated skin areas compared with 28% of patients in PDT-treated skin, with a total number of cumulated AKs in untreated skin (n=43) compared with PDTtreated skin (n=8), p=0.005. These preliminary data indicate a novel approach to early prevention of AKs in OTRs.

Key Words: Primary prevention, AK, Organ transplant recipients

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C29

Fractional laser-mediated PDT of high-risk BCC-a randomized clinical trial Uwe Paasch Leipzig, Germany C.S. Haak, K. Togsverd-Bo, D. Thaysen-Petersen, H.C. Wulf, R.R. Anderson, M. Haedersdal

Background: Photodynamic therapy (PDT) is approved for selected nodular basal cell carcinomas (nBCC) but efficacy is reduced for large and thick tumours. Methods: Patients with histologically verified high-risk nBCC (n=32) were included and randomized to AFXL-PDT (n=16) or PDT (n=16). AFXL was applied at 5% density and 1000µm ablation depth. MAL was applied under occlusion for 3 hours and illuminated with 633nm, 37J/cm2. Assessments were performed at 3, 6, 9, 12 months, biopsies taken at 12 months. Results: Clinical cure rates at 3 months were 100% (AFXL-PDT) and 88% (PDT, p=0.484). Histology at 12 months documented equal tumour clearance after AFXL-PDT (63%) and PDT (56%). Cosmetic outcomes were highly satisfying after both treatments (p>0.090). Conclusions: Long-term efficacy was similar after PDT and AFXL-PDT with a trend for a favourable short-term cure rate after AFXL-PDT. AFXL-PDT needs further refinement for nBCC and at present is not recommended over PDT.

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

C30

10 years of PDT experience for AK and BCC in Portugal Celeste Brito Braga, Portugal

Photodynamic therapy (PDT) is a well-established treatment for actinic keratosis (AK), basal-cell carcinomas (BCC), and Bowen´s disease (BD). The results of a retrospective analysis of patients treated with methyl aminolevulinate and red light PDT (MAL-PDT), over the past decade at the Hospital de Braga, Portugal, were statistically analysed on the basis of their clinical records. More than 550 patients with mean age of 72 years were treated with MAL-PDT. Two thirds of these patients were female. In terms of diagnostics, 67% of the patient population were affected with AK, 27% presented with BCC, and 4% had BD. With an average 5,5 year follow-up, 99.5% of the lesions were cleared. This experience in a European excellence center of PDT, where this therapy is used routinely, showed the excellence of MAL-PDT for treating AK, BCC and BD, with minimal recurrence rate.

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

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C31

New approaches to antimicrobial PDT* Santi Nonell Barcelona, Spain R. Ruiz-González, M. Agut

The antimicrobial drug resistance threat has stimulated the search for novel antimicrobial therapies that overcome the limitations of currently-available drugs. Owing to its multi-site and multi-target mechanism of action, PDT is unlikely to suffer from the same drawbacks as conventional drugs and should be considered as an alternative and be given an opportunity to realise its full potential. In this presentation, the state of the art in the development of antimicrobial photodynamic drugs will be reviewed and novel approaches will be presented and illustrated mainly with examples from our laboratory. *This work was supported by a grant of the Spanish Ministry of Economy and Competitiveness (CTQ2013-48767-C3-1-R).

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Key Words: Antimicrobial PDT, biological drugs, Drug resistance, Genetically-encoded photosensitisers, Nanoplasmonics, Singlet oxygen

C32

MAL-PDT for onychomycosis: A multicenter, randomized, controlled, clinical trial Yolanda Gilaberte Huesca, Spain P. Robres, MP. Frías, J. Vera-Alvarez, I. García-Dóval, A. Rezusta, C. Aspiroz

Background: Onychomycosis do not have a good response to antifungals. Objective: to investigate the efficacy and safety of methyl-aminolevulinate (MAL) photodynamic therapy (PDT) to treat onychomycosis. Methods: A multicentre (3), randomized, placebo-controlled clinical trial comparing 3 sessions of 40% urea plus conventional MAL-PDT with 40% urea plus red light (pPDT) in onychomycosis was performed. Clinical (evaluated by Onychomycosis Severity Index (OSI)) and microbiological efficacy was blindly evaluated after 36 weeks of follow-up. Results: One center was withdrawn from the study (n=20), leaving 40 patients in the trial. Twenty-two received MAL-PDT and 18 pPDT. Four patients (18.18%) in the former and 1 (5.56%) in the later were clinically cured (NTT 7.92, CI95% 2.98,9.69, p=0.23). Non-dystrophic onychomycosis showed better clinical response (OSI>75% 53,85% vs 18,75% (p =0,048) and microbiological cure (41.56% vs 7.14%,(p=0.037)) with MAL-PDT than those dystrophic. No significant side effects were reported. Limitations: the reduction of the sample size; efficacy in the control group could be attributed to application of 40% urea. Conclusion: this study did not show statistically significant differences between urea 40%-MAL-PDT and urea 40% plus red light for onychomycosis. However, in absence of total nail dystrophy, PDT was significantly better than placebo.

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

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C33

Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage Peter Bjerring Vejle, Denmark W.G. Philipp-Dormston, G. Sanclemente, L. Torezan, M. Tretti Clementoni, A. Le Pillouer-Prost, H. Cartier, R.M. Szeimies

Conventional PDT (c-PDT) is a widely used and approved non-invasive treatment for actinic keratosis (AK). However, pain and the need for special light source equipment are limiting factors for its use, especially in the treatment of large areas. Daylight PDT (DL-PDT) has subsequently shown similar efficacy to c-PDT in the treatment of AK. It is nearly painless and more convenient to perform. Recently, recommendations for the use of MAL DL-PDT in patients with large-scale photodamaged skin were developed by an international expert group, and the concept of 'actinic field damage' which refers to photodamage associated with actinic epidermal dysplasia was elaborated (J Eur Acad Dermatol Venereol. 2016 Jan;30(1):8-15). It was found that DL-PDT is not only efficacious but also nearly pain-free and easy to perform, and therefore results in high patient acceptance especially for the treatment of areas of actinic field damage.

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

C34

Aesthetic indications for PDT Matteo Tretti Clementoni Milan, Italy

PDT is an effective treatment for actinic keratosis and non-melanoma skin cancer. It also has several non-oncologic off-label indications, such as improvement of inflammatory diseases of the skin and virus-induced lesions. For those who use PDT, only for the approved treatment of actinic keratosis, most know that patients will comment on the cosmetic improvement in their skin quality after the procedure. These clinical findings have led to examination of PDT as an aesthetic indication. Previous studies related to the aesthetic outcomes of PDT show the improvement of lentigines, sallow complexion, skin roughness and fine wrinkles. Histologically, it is possible to observe the decrease of elastotic material and expression of p53, together with induction of neocollagenasis, an effect of cytokine induction. Comparison between IPL PDT and IPL alone demonstrated that IPL PDT is more effective. Furthermore PDL-PDT was shown to induce collagen production. More recently researchers/physicians’ attention has been focused not only on how to activate the photosensitizer but also on how to prepare the skin prior to its application. Microneedling, fractional lasers and sand paper are the most popular ways to prepare the skin also for cosmetic purposes. Many of these procedures will be described and results evaluated.

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Management of post-treatment erythema Peter Arne Gerber Duesseldorf, Germany

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

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

C36

Scalp nerve blocks for pain management during large field PDT Sigrid Karrer Regensburg, Germany

Pain is a major side effect of PDT when using red light for irradiation. To optimize pain management during conventional PDT with methyl aminolaevulinate in men with field cancerization on the scalp and forehead, the effect of either scalp nerve blocks, intravenous analgesia (piritramid 75 mg i.v. plus oral metamizole) in combination with cold-air analgesia and cold air analgesia alone was compared in a randomized controlled trial. Maximum pain during PDT was significantly reduced in the group receiving scalp nerve blocks (VAS 2.1+1.3). No significant difference in the VAS-scale was found between i.v. analgesia with cold air and cold air alone (7.3+1.1 resp. 8.4+2.0). Systolic blood pressure during the first 3 min of irradiation was significantly lower in the group receiving scalp nerve blocks. Clinical and cosmetic results were excellent in all treatment groups. This study shows the excellent pain alleviation of scalp nerve blocks during large field PDT, while i.v. analgesia and cold air did not result in a considerable reduction of pain.

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

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C37

DL-PDT with methyl-aminolevulinate in the treatment of actinic cheilitis Dario Fai Lecce, Italy C. Fai

Actinic cheilitis (AC) is a premalignant condition, whose management can be difficult. Ever-growing evidence suggested that PDT may be effective in AC, although pain is common and sometimes relevant. Daylight PDT (DL-PDT) is a simplified procedure that was found to be more tolerated than conventional PDT in patients with actinic keratosis. Eight patients with refractory AC were treated with DL-PDT using methyl-aminolevulinate (MAL). Two sessions were performed with an interval of 7-14 days. Exposure to daylight occurred within 30 min from MAL application and lasted for 2 hours, in all weather conditions except rain, usually between 08:30 and 11:00 a.m. A complete response was observed in 7 patients at 3 months and was maintained over the post-treatment period in most patients. Tolerability was good in all subjects but one. Our preliminary results suggest that DL-PDT is an interesting modality that can be considered for the treatment of AC.

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

C38

Cutaneous leishmaniasis responds to DL-PDT: proof of concept for a novel self-administered therapeutic modality Claes D. Enk Jerusalem, Israel C. Jaffe, H.C. Wulf

Background Cutaneous leishmaniasis (CL) is a vector-born disease with an incidence approaching 2 mill new cases yearly. Photodynamic therapy is highly effective for CL, but requires equipment only available at specialized treatment centers. Objectives The objective of this single-center, open study was to establish proof-of-concept for the efficacy of DL-PDT in the treatment of CL using clinical, microbiological, and molecular clearance as outcome measures. Methods Thirty-one patients with CL underwent DL-PDT. Fourteen patients were treated in the hospital garden under professional supervision and 17 patients underwent DL-PDT as self-administered treatment modality at home. Treatment sessions were repeated at weekly intervals until clinical and microbiological cure. Results The overall cure rate for hospital-based and self-administered DL-PDT was 88.9 % (Intention-to-Treat cure rate 77.4%), for the hospital-based treatment group alone 85.7%, and for self-administered treatment 92.3%. Conclusions DL-PDT proved to be effective in the treatment of CL caused by L. major and L. tropica.

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

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PDT for Acne Ann-Marie Wennberg Gothenburg, Sweden

Photodynamic Therapy with methylaminolevulinate 80 mg/g demonstrates significant efficacy in acne. Aims: To investigate efficacy and safety of methylaminolevulinate (MAL) at 80 mg/g vs vehicle cream followed by red light illumination in severe acne patients. Methods: Multicenter, randomized, double-blind and vehicle controlled study. A total of 153 male and female patients aged 12 to 35 years were enrolled at 15 sites in the US having Fitzpatrick skin type I through VI, 25 to 75 inflammatory and 20 to 100 noninflammatory acne lesions, no more than 3 nodules on the face and an Investigator’s Global Assessment (IGA) score of 4. MAL or vehicle cream was applied on the skin and left to incubate under occlusion for 1.5 hours before illumination with a light dose of 37 J/cm2 (red light with average wavelength of 632 nm) using a lamp with a total of 512 light emitting diodes (LEDs) covering an area of approximately 32 cm x 18 cm. All patients received 4 treatments 2 weeks apart (at weeks 0, 2, 4 and 6). The primary endpoint was reduction of inflammatory lesions 6 weeks after the last treatment (week 12). Secondary endpoints were proportion of patients with success according to IGA (success defined as an improvement of at least 2 grades from baseline), reduction in noninflammatory lesions, pain during illumination using a Visual Analogue Scale (VAS) from 0 to 10 and erythema score. Results: Patients treated with MAL had a statistically significant reduction in inflammatory lesions of 43.8% as compared to 26.6% in the vehicle group (p=0.003). MAL showed a statistically significant improved IGA treatment success rate compared to vehicle, 44.0% versus 26.4% (p=0.013). A comparable reduction in noninflammatory lesions was achieved in both groups (p=0.853). Post treatment erythema was reported more frequently in the MAL group (89% versus 70%), which generally subsided by the following day. Twelve patients withdrew from the study due to adverse events. Six (6%) patients in the MAL group withdrew due to pain related adverse events (pain, burning or stinging). No serious adverse events were reported in the study. Conclusions: MAL significantly decreased the number of inflammatory lesions and significantly improved IGA success rate. Comparable efficacy was demonstrated in reducing noninflammatory lesions and the treatment was well tolerated.

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Key Words: Acne,Inflammatory lesions, MAL, PDT

POSTERS

P1

PDT with topical 5% 5-aminolevulinic acid for the treatment of truncal acne in Asian patients Yik Weng Yew Singapore Y.C. Lai, Y.L. Lim, W.S. Chong, C.T. Theng

Background: Photodynamic therapy (PDT) using topical application of aminolevulinic acid (ALA) is an effective treatment for acne vulgaris. However, there is no clear consensus on the treatment regime in Asians. Aim: To determine the efficacy, safety and tolerability of 5%-ALA PDT in the treatment of truncal acne in Asians. Methods: Patients with truncal acne were treated with 5%-ALA under occlusion for 3 hours. All were treated with a red light source at wavelength 630 nm and an irradiance of 38mW/cm2 giving a total dose of 37 J/cm2. The numbers of acne lesions were recorded at baseline and regular intervals. Results: Fifteen patients were recruited. Overall, there was a 64.2% reduction in the inflammatory lesions count and a 24.3% reduction in the non-inflammatory lesions count at the end of the 12 weeks follow-up. Both mean lesions counts were significantly lower than baseline at all follow-up time points with paired t tests (all p values

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