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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04319159
The ClinicalTrials.gov registry entry for NCT04319159 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 94-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (49% lower). The listed sponsor is Biofrontera Bioscience, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.