drugset / Trial / NCT05060237

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

NCT05060237

Phase 1 Completed 112 enrolled Biofrontera Bioscience GmbH
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-12-01
Primary completion
2023-04-20
Completion
2023-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent Topical