Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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).
NCT03573401 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- COMBINATION_PRODUCT Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
- COMBINATION_PRODUCT Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
Study Locations (18)
New York
- The Narrows Institute for Biomedical Research and Education, Inc. — Brooklyn
- Skin Search of Rochester, Inc — Rochester
- Rochester Dermatologic Surgery — Victor
Arizona
- Medical Dermatology Specialists — Phoenix
- Alliance Dermatology & Mohs Center — Phoenix
California
- First OC Dermatology — Fountain Valley
- Cosmetic Laser Dermatology — San Diego
Florida
- Dermatology Associates PA of the Palm Beaches — Delray Beach
- University of Florida Dept of Dermatology — Gainesville
Texas
- Austin Institute for Clinical Research Inc. — Houston
- Austin Institute for Clinical Research Inc. — Pflugerville
Colorado
- AboutSkin Research, LLC — Greenwood Village
Indiana
- Laser and Skin Surgery Center of Indiana — Indianapolis
Michigan
- Henry Ford Health System — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2029-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03573401
The ClinicalTrials.gov registry entry for NCT03573401 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biofrontera, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Superficial Basal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03573401 reports 18 study locations spanning 12 distinct geographic areas — top geographies include New York, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03573401 about?
NCT03573401 is a clinical study titled "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).". 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).
What is the current status of trial NCT03573401?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2018-09-25. Estimated completion is 2029-02.
What conditions does trial NCT03573401 study?
This clinical trial studies the following conditions: Superficial Basal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03573401?
The interventions under investigation include: Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (COMBINATION_PRODUCT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03573401?
This trial is sponsored by Biofrontera, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03573401 being conducted?
This trial has 18 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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