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
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
120actual
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-10 | actual | When the study began enrolling |
| Primary completion | 2025-08-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-07 | actual | The whole study's end, after follow-up |
| First posted | 2021-10-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acne Vulgaris
Interventions
- Combination product: 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)
Primary outcomes
what the primary-completion date above is the date OFRelative change in the number of inflammatory lesions (relative change from baseline) 8 weeks after the last PDT as assessed by investigator.
measured 8 weeks after the last PDT
Treatment success defined by a minimum improvement of the modified investigator global assessment (mIGA) score by at least 2 assessed 8 weeks after the last PDT and resulting in an mIGA score of 0 (clear) or 1 (almost clear).
measured 8 weeks after the last PDT
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