Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)

Summary

The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Timeline

Start

2013-10

Primary completion

2014-09

Completion

2015-04

Publications

• Reinhold U, Philipp-Dormston WG, Dirschka T, Ostendorf R, Aschoff R, Berking C, Jager A, Schmitz B, Foguet M, Szeimies RM. Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED(R) lamp. J Eur Acad Dermatol Venereol. 2025 Aug;39(8):1449-1459. doi: 10.1111/jdv.20452. Epub 2024 Dec 12.

Drugs

Indications