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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05080764
The ClinicalTrials.gov registry entry for NCT05080764 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 273-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (54% lower). The listed sponsor is Biofrontera, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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