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NCT05060237 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp

A Phase 1 study, sponsored by Biofrontera Bioscience.

Completed
Registry status
Phase 1
Development phase
112
Enrollment target

NCT05060237 is a Phase 1 study that has completed, run by Biofrontera Bioscience. The registered enrollment target is 112 participants.

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The verdict

NCT05060237, a Phase 1 study, has completed, sponsored by Biofrontera Bioscience.

COMPLETED
Registry status
Phase 1
Development phase
112 participants
Enrollment target

Study Summary

The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

Interventions

  • COMBINATION_PRODUCT BF-200 ALA and red light LED lamp

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2021-12-01
Est. Completion 2023-04-20
Phase Phase 1

Sponsor

Biofrontera Bioscience

2 total trials

What the Registry Record Tells You About NCT05060237

The ClinicalTrials.gov registry entry for NCT05060237 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biofrontera Bioscience, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which BF-200 ALA and red light LED lamp is the first listed.

NCT05060237 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05060237 about?

NCT05060237 is a clinical study titled "Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp". The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.

What is the current status of trial NCT05060237?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2021-12-01. Estimated completion is 2023-04-20.

What interventions are being tested in trial NCT05060237?

The interventions under investigation include: BF-200 ALA and red light LED lamp (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05060237?

This trial is sponsored by Biofrontera Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.