Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

December 12, 2022

Primary Completion Date

September 3, 2025

Study Completion Date

June 30, 2026

Conditions
Actinic Keratoses
Interventions
COMBINATION_PRODUCT

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."

COMBINATION_PRODUCT

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."

Trial Locations (14)

14564

Rochester Dermatologic Surgery, Victor

14623

Skin Search of Rochester, Inc., Rochester

29407

Clinical Research Center of the Carolinas, Charleston

30078

Gwinnett Clinical Research Center, Inc., Snellville

33445

Dermatology Associates PA of the Palm Beaches, Delray Beach

46168

The Indiana Clinical Trials Center, PC, Plainfield

46260

Laser and Skin Surgery Center of Indiana, Indianapolis

70809

DelRicht Research, Baton Rouge

77056

Austin Institute for Clinical Research, Houston

78660

Austin Institute for Clinical Research Inc., Pflugerville

78759

DermResearch, P.A., Austin

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