drugset / Trial / NCT05080764

Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults

NCT05080764

Phase 2 Completed 120 enrolled Biofrontera Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.

Timeline

Start
2021-12-10
Primary completion
2025-08-22
Completion
2026-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Aminolevulinic Acid Diagnostic / imaging agent 7.8 % Topical

Indications