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
Public ClinicalTrials.gov record NCT05080764. 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 II Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris in Adults With Photodynamic Therapy (PDT)
Study identification
- NCT ID
- NCT05080764
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Biofrontera Inc.
- Industry
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
- 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
Combination Product
Eligibility (public fields only)
- Age range
- 16 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 9, 2021
- Primary completion
- Aug 21, 2025
- Completion
- Jan 6, 2026
- Last update posted
- Jul 7, 2026
2021 – 2026
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| Cosmetic Laser Dermatology | San Diego | California | 92121 | — |
| Dermatology Associates PA of the Palm Beaches | Delray Beach | Florida | 33445 | — |
| ForCare Clinical Research | Tampa | Florida | 17033 | — |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | — |
| Skin Search of Rochester, Inc | Rochester | New York | 14623 | — |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | — |
| DermResearch PA | Austin | Texas | 78759 | — |
| 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 NCT05080764, 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 Jul 7, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05080764 live on ClinicalTrials.gov.