CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 112 enrolled
Drug / intervention
BF-200 ALA and red light LED lampcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05060237
NCT05060237Phase 1Completed
CompareCT.gov

A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)

Biofrontera Bioscience GmbH·interventional·Posted Sep 29, 2021·Updated Oct 17, 2024

In Brief

A Phase 1 clinical trial evaluating BF-200 ALA and red light LED lamp for Actinic Keratosis and 2 related conditions. Completed, enrolled 112 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis, Keratosis, Actinic, Keratosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedSep 29, 2021
Enrollment StartDec 1, 2021
Primary CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.8 years ago

Interventions

BF-200 ALA and red light LED lampcombination

Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT): Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing.