Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

Summary

The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

Timeline

Start

2014-01-28

Primary completion

2015-11-17

Completion

2020-09-09

Publications

• Results Morton CA, Dominicus R, Radny P, Dirschka T, Hauschild A, Reinhold U, Aschoff R, Ulrich M, Keohane S, Ekanayake-Bohlig S, Ibbotson S, Ostendorf R, Berking C, Grone D, Schulze HJ, Ockenfels HM, Jasnoch V, Kurzen H, Sebastian M, Stege H, Staubach P, Gupta G, Hubinger F, Ziabreva I, Schmitz B, Gertzmann A, Lubbert H, Szeimies RM. A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF-200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy. Br J Dermatol. 2018 Aug;179(2):309-319. doi: 10.1111/bjd.16441. Epub 2018 May 16.

Drugs

Indications