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
Public ClinicalTrials.gov record NCT05662202. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05662202
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 172 participants
Conditions and interventions
Conditions
Interventions
- BF-200 ALA and red light LED lamp Combination Product
- Vehicle and red light LED lamp Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2022 (Actual)
- Primary completion
- Sep 3, 2025 (Actual)
- Completion
- Jul 1, 2026 (Actual)
- Last update posted
- Aug 21, 2026
2022 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | — |
| Alliance Dermatology & Mohs Center | Phoenix | Arizona | 85032 | — |
| Dermatology Practice | Greenwood Village | Colorado | 80111 | — |
| Dermatology Associates PA of the Palm Beaches | Delray Beach | Florida | 33445 | — |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | — |
| Laser and Skin Surgery Center of Indiana | Indianapolis | Indiana | 46260 | — |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | — |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | — |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | — |
| Rochester Dermatologic Surgery | Victor | New York | 14564 | — |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | — |
| DermResearch, P.A. | Austin | Texas | 78759 | — |
| Austin Institute for Clinical Research | Houston | Texas | 77056 | — |
| Austin Institute for Clinical Research Inc. | Pflugerville | Texas | 78660 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05662202, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05662202 live on ClinicalTrials.gov.