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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Biofrontera Bioscience GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis
• Keratosis, Actinic
• Keratosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BF-200 ALA and red light LED lamp	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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2021-09-29
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study