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
← catalyst calendarSponsored by Biofrontera Inc. (industry) · BFRI — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
172actual
Sites
14
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 | 2022-12-12 | actual | When the study began enrolling |
| Primary completion | 2025-09-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-01 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Actinic Keratoses
Interventions
- Combination product: BF-200 ALA and red light LED lamp
- Combination product: Vehicle and red light LED lamp
Primary outcome
what the primary-completion date above is the date OFOverall subject complete response rate
measured 12 weeks after the last PDT (Visit 4 or Visit 6)
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