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NCT05060237 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
A Phase 1 study, sponsored by Biofrontera Bioscience.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT05060237: Completed Phase 1 study, sponsored by Biofrontera Bioscience.
NCT05060237 is a Phase 1 study that has completed, run by Biofrontera Bioscience. The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05060237, a Phase 1 study, has completed, sponsored by Biofrontera Bioscience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.
Primary Outcome
TEAEs are defined as all AEs with onset or worsening after treatment with IMP up to Visit 5 (Final Visit). TEAEs are considered being related to IMP or medical device, if causal relationship between IMP or medical device and the TEAE is at least possible or relationship assessment is missing. If an AE occurs in different treatment areas (face, scalp, face and scalp), it is reported separately for each treatment area. Thus, some AEs are counted more than once.
Interventions
- COMBINATION_PRODUCT BF-200 ALA and red light LED lamp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 1 |
What the finished NCT05060237 record still lists
NCT05060237 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher).
The record links to 0 conditions, and to 1 intervention - of which BF-200 ALA and red light LED lamp is the first listed.
NCT05060237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05060237 about?
NCT05060237 is a clinical study titled "Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp". The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.
What is the current status of trial NCT05060237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2021-12-01. Estimated completion is 2023-04-20.
What interventions are being tested in trial NCT05060237?
The interventions under investigation include: BF-200 ALA and red light LED lamp (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05060237?
This trial is sponsored by Biofrontera Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05060237's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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