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NCT05080764 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
A Phase 2 study of Acne Vulgaris, sponsored by Biofrontera.
- Active
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
- 9
- Study locations
NCT05080764: Active Phase 2 study of Acne Vulgaris, sponsored by Biofrontera.
NCT05080764 is a Phase 2 study of Acne Vulgaris that is active but no longer recruiting, run by Biofrontera. The registered enrollment target is 126 participants, below the 273-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (54% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05080764, a Phase 2 study of Acne Vulgaris, is active but no longer recruiting, sponsored by Biofrontera.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
- 9
- Study locations
Study Summary
The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.
Primary Outcome
Outcome 1 is the relative change in the number of inflammatory lesions at the final visit with respect to baseline as assessed by the investigator.
Conditions Studied
Interventions
- COMBINATION_PRODUCT 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
- COMBINATION_PRODUCT 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
- COMBINATION_PRODUCT 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)
- COMBINATION_PRODUCT 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
Study Locations (9)
California
- First OC Dermatology - Fountain Valley
- Cosmetic Laser Dermatology - San Diego
Florida
- Dermatology Associates PA of the Palm Beaches - Delray Beach
- ForCare Clinical Research - Tampa
Texas
- DermResearch PA - Austin
- Austin Institute for Clinical Research Inc. - Pflugerville
Louisiana
- DelRicht Research - Baton Rouge
New York
- Skin Search of Rochester, Inc - Rochester
South Carolina
- Clinical Research Center of the Carolinas - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What the registry record for NCT05080764 still lists
NCT05080764 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 273-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 4 interventions - of which 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) is the first listed.
NCT05080764 lists 9 locations in 6 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT05080764 about?
NCT05080764 is a clinical study titled "Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults". The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.
What is the current status of trial NCT05080764?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2021-12-10. Estimated completion is 2026-01.
What conditions does trial NCT05080764 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT05080764?
The interventions under investigation include: 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (COMBINATION_PRODUCT), 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (COMBINATION_PRODUCT), 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) (COMBINATION_PRODUCT), 3h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05080764?
This trial is sponsored by Biofrontera, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05080764 being conducted?
This trial has 9 study locations across California, Florida, Louisiana, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05080764's enrollment target sits among peer trials
126 34th of 67 higher than 34 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris 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.
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