Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

PHASE1CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

April 20, 2023

Study Completion Date

April 20, 2023

Conditions
Actinic KeratosisKeratosis, ActinicKeratosis
Interventions
COMBINATION_PRODUCT

BF-200 ALA and red light LED lamp

"Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT):~Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing."

Trial Locations (9)

14564

Rochester Dermatologic Surgery, Victor

14623

Skin Search of Rochester, Inc, Rochester

29407

Clinical Research Center of the Carolinas, Charleston

46260

Laser and Skin Surgery Center of Indiana, Indianapolis

77056

Austin Institute for Clinical Research, Houston

78660

Austin Institute for Clinical Research Inc., Pflugerville

80111

Dermatology Practice, Greenwood Village

85006

Medical Dermatology Specialists, Phoenix

85032

Alliance Dermatology & Mohs Center, Phoenix

Sponsors
All Listed Sponsors
lead

Biofrontera Bioscience GmbH

INDUSTRY