Daylight photodynamic therapy with methyl aminolevulinate cream is effective and nearly painless in treating actinic keratoses: a randomised, investigator‐blinded, controlled, phase III study throughout Europe

• DOI: 10.1111/jdv.13228
• Publication Date: 2015-10-05T11:22:55Z
• Authors: 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; R‐M. Szeimies
• Keywords: Actinic keratosis; Actinic Keratoses; Target lesion; Clinical endpoint

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