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NCT04319159 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)
A Phase 1 study of Actinic Keratoses, sponsored by Biofrontera Bioscience.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04319159: Completed Phase 1 study of Actinic Keratoses, sponsored by Biofrontera Bioscience.
NCT04319159 is a Phase 1 study of Actinic Keratoses that has completed, run by Biofrontera Bioscience. The registered enrollment target is 48 participants, below the 94-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319159, a Phase 1 study of Actinic Keratoses, has completed, sponsored by Biofrontera Bioscience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX) during photodynamic therapy with 3 tubes of BF-200 ALA 10% gel (Ameluz®) in combination with the BF-RhodoLED® lamp in the systemic circulation of diseased individuals presenting with actinic keratosis (AK) on the face/scalp or in the periphery (neck/trunk/extremities) along with subjects' safety/tolerability during and after treatment.
Primary Outcome
Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
Conditions Studied
Interventions
- COMBINATION_PRODUCT BF-200 ALA and red light LED lamp
Study Locations (1)
Texas
- DermResearch Inc. - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-03-05 |
| Est. Completion | 2020-10-07 |
| Phase | Phase 1 |
What the finished NCT04319159 record still lists
NCT04319159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 94-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Actinic Keratoses appearing as the primary indexed condition, and to 1 intervention - of which BF-200 ALA and red light LED lamp is the first listed.
NCT04319159 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04319159 about?
NCT04319159 is a clinical study titled "Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)". The aim of this study is to assess the pharmacokinetics (PK) of the parent drug 5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX) during photodynamic therapy with 3 tubes of BF-200 ALA 10% gel (Ameluz®) in combination with the BF-RhodoLED® lamp in the systemic circulatio...
What is the current status of trial NCT04319159?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-03-05. Estimated completion is 2020-10-07.
What conditions does trial NCT04319159 study?
This clinical trial studies the following conditions: Actinic Keratoses.
What interventions are being tested in trial NCT04319159?
The interventions under investigation include: BF-200 ALA and red light LED lamp (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04319159?
This trial is sponsored by Biofrontera Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04319159 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Actinic Keratoses
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04319159's enrollment target sits among peer trials
48 6th of 12 higher than 7 of 12 other Actinic Keratoses trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratoses 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
-
Daylight Photodynamic Therapy for Actinic Keratosis
COMPLETED · Phase 1
-
Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
COMPLETED · Phase 1
-
Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face
RECRUITING · Phase 4
-
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
RECRUITING · NA
-
The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
RECRUITING · NA
-
Photodynamic Therapy Incubation Times for Actinic Keratosis
ACTIVE NOT RECRUITING · NA
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