Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).

Summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).

Timeline

Start

2018-09-25

Primary completion

2024-03-19

Completion

2029-02

Publications

• Schlesinger T, Chapman MS, Tu JH, Cohen JL, Strasswimmer J, Zeitouni NC, Torres A, Jazayeri SS, Goldman MP, Ibrahim SF, Lain EL, Couvillion MP, Bruce S, Laquer VT, Hanke CW, Ozog DM, Schneider J, Markowitz O, Berman B, Nestor MS, Gold MH, Munavalli GS, Forsha DW, Siegel DM, Mrohs D, Schmitz B, Schaning R, Pospiech N, Lyons J, Foguet M, Lubbert M, Lubbert H, Pariser DM. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025 Dec;93(6):1489-1498. doi: 10.1016/j.jaad.2025.08.031. Epub 2025 Aug 20.

Drugs

Indications