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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: Active Phase 3 study of Actinic Keratoses, sponsored by Biofrontera.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of subjects with all AK target lesions clinically cleared after last PDT
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 |
What the registry record for NCT05662202 still lists
NCT05662202 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (105% higher).
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 lists 14 locations in 9 states (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
Similar trials for Actinic Keratoses
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05662202's enrollment target sits among peer trials
172 2nd of 12 the highest of 12 other Actinic Keratoses trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratoses trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
COMPLETED · Phase 3
-
Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face
RECRUITING · Phase 4
-
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
RECRUITING · NA
-
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
RECRUITING · NA
-
Photodynamic Therapy Incubation Times for Actinic Keratosis
ACTIVE NOT RECRUITING · NA
-
Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
COMPLETED · NA
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