• J-P Lacour, C Ulrich, Y Gilaberte, V Von Felbert, N Basset-Seguin, B Dreno, C Girard, P Redondo, C Serra-Guillen, I Synnerstad, M Tarstedt, A Tsianakas, A W Venema, N Kelleners-Smeets, H Adamski, B Perez-Garcia, M J Gerritsen, S Leclerc, N Kerrouche, and R-M Szeimies.
• Department of Dermatology, Hôpital Archet2, University Hospital of Nice, Nice, France.
• J Eur Acad Dermatol Venereol. 2015 Dec 1; 29 (12): 2342-8.

BackgroundUnmet needs exist in actinic keratosis (AK) treatment. Daylight photodynamic therapy (DL-PDT) has shown good efficacy and safety results compared to conventional PDT (c-PDT) in a recent Phase III multi-centre randomised controlled trial in Australia among 100 subjects with AKs.ObjectivesDemonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and/or moderate facial/scalp AKs.MethodsPhase III, 12 week, multi-centre, randomised, investigator-blinded, controlled, intra-individual study conducted at different latitudes in Europe. AKs of adult subjects were treated once with methyl aminolevulinate (MAL) DL-PDT on one side of the face and MAL c-PDT contralaterally. Endpoints for DL-PDT concerned efficacy (non-inferiority regarding complete lesion response at week 12) and safety (superiority regarding subject's assessment of pain after treatment, on an 11-point numeric rating scale). Safety evaluation also included incidence of adverse events. Subject satisfaction was described using a questionnaire at baseline and last visit.ResultsAt week 12, the total lesion complete response rate with DL-PDT was similar (non-inferior) to c-PDT (70% vs. 74%, respectively; 95% CI [-9.5; 2.4] in PP analysis, confirmed in ITT analysis). In addition, efficacy of DL-PDT was demonstrated regardless of weather conditions (sunny or cloudy). DL-PDT was nearly painless compared to c-PDT (0.7 vs. 4.4, respectively; P < 0.001), better tolerated and resulted in higher subject satisfaction.ConclusionDL-PDT in comparison with c-PDT was as effective, better tolerated and nearly painless with high patient satisfaction, and may be considered a treatment of choice to meet needs of patients with mild or moderate facial/scalp AKs.© 2015 European Academy of Dermatology and Venereology.

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