Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
Active, not recruiting · Phase 3 · NCT03573401
Conditions: Superficial Basal Cell Carcinoma
At a glance
- Research payments reported, 2025
- $48,739
- U.S. investigators named
- 16
- Sites paid
- 17
- Planned or actual enrollment
- 187
About the trial
- Sponsor
- Biofrontera Inc.
- Tested
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (combination_product), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (combination_product)
- Dates
- Started 2018-09-25; completion 2029-02
- Results posted
- Yes
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).
From ClinicalTrials.gov, last updated 2026-01-14. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Biofrontera Inc. reported $48,739 in research payments for this study in 2025 (36 payments).
Products named: Bf-Rhodoled, Rhodoled Xl, 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
- Mitchel P. Goldman, M.D. Dermatology · San Diego, CA
- Tien Q. Nguyen, MD Dermatology · Fountain Valley, CA
- Abel Torres, M.D. Mohs Surgery · Loma Linda, CA
- Joel L. Cohen, M.D. Mohs Surgery · Greenwood Village, CO
- John M. Strasswimmer, M.D. Dermatology · Salida, CO
- Carl W. Hanke, MD Mohs Surgery · Indianapolis, IN
- David M. Ozog, M.D. Mohs Surgery · Detroit, MI
- Michael S. Chapman, M.D. Dermatology · Lebanon, NH
- Sherrif F. Ibrahim, MD Mohs Surgery · Victor, NY
- John H. Tu, MD Dermatology · Rochester, NY
- Todd E. Schlesinger, M.D. Dermatology · Charleston, SC
- Megan P. Couvillion, MD Dermatology · Houston, TX
- Edward L. Lain, M.D. Dermatology · Austin, TX
- David Pariser, M.D. Dermatology · Norfolk, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Darthmouth-Hitchcock Medical Center - Dept of Dermatology $16,102
- Clinical Research Center of the Carolinas $7,405
- Alliance Dermatology & Mohs Center $7,010
- UCSF Dermatology Department $6,188
- Rochester Dermatologic Surgery $4,510
- Laser & Skin Surgery Center of Indiana (the Lassi) $1,626
- Aboutskin Dermatology & Derm Surgery $1,600
- Oc Dermatology $1,590
- Skin Search of Rochester $1,070
- Cosmetic Laser Dermatology $1,065
- Virginia Clinical Research $530
- Dermatology Associates of the Palm Beaches - Delray $10
- Austin Institute for Clinical Research Inc $8
- Medical Dermatology Specialists $8
- Cosmetic Laser and Dermatology $7
- Henry Ford Medical Center $6
- Laser and Skin Surgery Center of Indiana $5
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.