Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
Completed · Phase 2 · NCT05080764
Conditions: Acne Vulgaris
At a glance
- Research payments reported, 2025
- $71,064
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 120
About the trial
- Sponsor
- Biofrontera Inc.
- Tested
- 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (combination_product), 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (combination_product), 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (combination_product), 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (combination_product)
- Dates
- Started 2021-12-10; completion 2026-01-07
- Results posted
- Yes
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.
From ClinicalTrials.gov, last updated 2026-10-01. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Biofrontera Inc. reported $71,064 in research payments for this study in 2025 (21 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
- Mitchel P. Goldman, M.D. Dermatology · San Diego, CA
- Ira H. Thorla JR., M.D. Dermatology · Baton Rouge, LA
- 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
- Cosmetic Laser Dermatology $37,524
- Skin Search of Rochester $14,716
- Delricht Research $9,554
- Clinical Research Center of the Carolinas $7,568
- Austin Institute for Clinical Research Inc $1,703
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.