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NCT05662202 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Actinic Keratoses, sponsored by Biofrontera.
- Active
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
- 14
- Study locations
NCT05662202 is a Phase 3 study of Actinic Keratoses that is active but no longer recruiting, run by Biofrontera. The registered enrollment target is 172 participants, above the 84-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (105% higher). The trial reports 14 study locations across 9 states.
The verdict
NCT05662202, a Phase 3 study of Actinic Keratoses, is active but no longer recruiting, sponsored by Biofrontera.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
- 14
- Study locations
Study Summary
The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
Conditions Studied
Interventions
- COMBINATION_PRODUCT BF-200 ALA and red light LED lamp
- COMBINATION_PRODUCT Vehicle and red light LED lamp
Study Locations (14)
Texas
- DermResearch, P.A. - Austin
- Austin Institute for Clinical Research - Houston
- Austin Institute for Clinical Research Inc. - Pflugerville
Arizona
- Medical Dermatology Specialists - Phoenix
- Alliance Dermatology & Mohs Center - Phoenix
Indiana
- Laser and Skin Surgery Center of Indiana - Indianapolis
- The Indiana Clinical Trials Center, PC - Plainfield
New York
- Skin Search of Rochester, Inc. - Rochester
- Rochester Dermatologic Surgery - Victor
Colorado
- Dermatology Practice - Greenwood Village
Florida
- Dermatology Associates PA of the Palm Beaches - Delray Beach
Georgia
- Gwinnett Clinical Research Center, Inc. - Snellville
Louisiana
- DelRicht Research - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05662202
The ClinicalTrials.gov registry entry for NCT05662202 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 84-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (105% higher). The listed sponsor is Biofrontera, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Actinic Keratoses appearing as the primary indexed condition, and to 2 interventions - of which BF-200 ALA and red light LED lamp is the first listed.
NCT05662202 reports 14 study locations spanning 9 distinct geographic areas - top geographies include Texas, Arizona, Indiana.
Frequently Asked Questions
What is clinical trial NCT05662202 about?
NCT05662202 is a clinical study titled "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". The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis ...
What is the current status of trial NCT05662202?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2022-12-12. Estimated completion is 2026-06.
What conditions does trial NCT05662202 study?
This clinical trial studies the following conditions: Actinic Keratoses.
What interventions are being tested in trial NCT05662202?
The interventions under investigation include: BF-200 ALA and red light LED lamp (COMBINATION_PRODUCT), Vehicle and red light LED lamp (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05662202?
This trial is sponsored by Biofrontera, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662202 being conducted?
This trial has 14 study locations across Arizona, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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