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
Completed · Phase 3 · NCT05662202
Conditions: Actinic Keratoses
At a glance
- Research payments reported, 2025
- $505,819
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 172
About the trial
- Sponsor
- Biofrontera Inc.
- Tested
- BF-200 ALA and red light LED lamp (combination_product), Vehicle and red light LED lamp (combination_product)
- Dates
- Started 2022-12-12; completion 2026-07-01
- Results posted
- Yes
The aim of this study is to test the safety, tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
From ClinicalTrials.gov, last updated 2026-08-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Biofrontera Inc. reported $505,819 in research payments for this study in 2025 (53 payments).
Products named: Rhodoled Xl, Bf-Rhodoled, Ameluz
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Sadra S. Jazayeri, MD Dermatology · Phoenix, AZ
- Nathalie Zeitouni, MD Dermatology · Phoenix, AZ
- Joel L. Cohen, M.D. Mohs Surgery · Greenwood Village, CO
- John M. Strasswimmer, M.D. Dermatology · Salida, CO
- Jonathan S. Weiss, MD Dermatology · Snellville, GA
- Scott T. Guenthner, MD Dermatology · Greenwood, IN
- Ira H. Thorla JR., M.D. Dermatology · Baton Rouge, LA
- Sherrif F. Ibrahim, MD Mohs Surgery · Victor, NY
- John H. Tu, MD Dermatology · Rochester, NY
- Todd E. Schlesinger, M.D. Dermatology · Charleston, SC
- Edward L. Lain, M.D. Dermatology · Austin, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Indiana Clinical Trials Center $132,057
- Delricht Research $99,102
- Gwinnett Clinical Research Center Inc $50,970
- Alliance Dermatology & Mohs Center $45,231
- Skin Search of Rochester $44,730
- Aboutskin Dermatology & Derm Surgery $31,768
- Rochester Dermatologic Surgery $28,426
- Medical Dermatology Specialists $27,517
- Clinical Research Center of the Carolinas $24,112
- Austin Institute for Clinical Research Inc $14,041
- Dermatology Associates of the Palm Beaches - Delray $7,865
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.