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NCT03573401 · ClinicalTrials.gov registry record · Phase 3
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).
A Phase 3 study of Superficial Basal Cell Carcinoma, sponsored by Biofrontera.
- Active
- Registry status
- Phase 3
- Development phase
- 187
- Enrollment target
- 18
- Study locations
NCT03573401: Active Phase 3 study of Superficial Basal Cell Carcinoma, sponsored by Biofrontera.
NCT03573401 is a Phase 3 study of Superficial Basal Cell Carcinoma that is active but no longer recruiting, run by Biofrontera. The registered enrollment target is 187 participants, above the 79-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (137% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03573401, a Phase 3 study of Superficial Basal Cell Carcinoma, is active but no longer recruiting, sponsored by Biofrontera.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 187 participants
- Enrollment target
- 18
- Study locations
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).
Primary Outcome
Each subject had one Main Target Lesion. The composite clinical and histological response rate of the subjects' Main Target Lesions is the percentage of subjects with a clinically and histologically cleared Main Target lesion 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion (Visit 5 or Visit 8).
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 |
What the registry record for NCT03573401 still lists
NCT03573401 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 5 other Superficial Basal Cell Carcinoma trials with a reported enrollment target (137% higher).
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.
NCT03573401 lists 18 locations in 12 states (New York, Arizona, California).
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.
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).
Who is sponsoring clinical trial NCT03573401?
This trial is sponsored by Biofrontera, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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