172
Participants
Start Date
December 12, 2022
Primary Completion Date
September 3, 2025
Study Completion Date
June 30, 2026
BF-200 ALA and red light LED lamp
"Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT):~Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.~PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit."
Vehicle and red light LED lamp
"Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT):~Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.~PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit."
Rochester Dermatologic Surgery, Victor
Skin Search of Rochester, Inc., Rochester
Clinical Research Center of the Carolinas, Charleston
Gwinnett Clinical Research Center, Inc., Snellville
Dermatology Associates PA of the Palm Beaches, Delray Beach
The Indiana Clinical Trials Center, PC, Plainfield
Laser and Skin Surgery Center of Indiana, Indianapolis
DelRicht Research, Baton Rouge
Austin Institute for Clinical Research, Houston
Austin Institute for Clinical Research Inc., Pflugerville
DermResearch, P.A., Austin
Dermatology Practice, Greenwood Village
Medical Dermatology Specialists, Phoenix
Alliance Dermatology & Mohs Center, Phoenix
Lead Sponsor
Biofrontera Bioscience GmbH
INDUSTRY