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).
← catalyst calendarSponsored by Biofrontera Inc. (industry) · BFRI — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
187actual
Sites
18
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 | 2018-09-25 | actual | When the study began enrolling |
| Primary completion | 2024-03-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2018-06-29 | actual | When this record first appeared on the registry |
| Results posted | 2025-04-29 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Superficial Basal Cell Carcinoma
Interventions
- Combination product: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) — also filed as ALA-PDT, Ameluz®-PDT
- Combination product: Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
Primary outcome
what the primary-completion date above is the date OFComposite Clinical and Histological Response of the Subject's Main Target Lesion as Assessed 12 Weeks After the Start of the Last PDT Cycle That Included Treatment of the Main Target Lesion.
measured 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2018-07-17 · 2.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-07-29 · 4.1 MB · SAP_001.pdf
Publications
- PMID 40846240 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · BFRI's whole pipeline · Catalyst calendar · Every registered study · What changed