NCT02144077

Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Biofrontera Bioscience GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

Detailed description

The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart. If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycle starting on the same day.

Conditions

• Basal Cell Carcinoma (BCC)

Interventions

Type	Name	Description
DRUG	BF-200 ALA	Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
DRUG	methyl-aminolevulinate	Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

Timeline

• Start date: 2014-01-28
• Primary completion: 2015-11-17
• Completion: 2020-09-09
• First posted: 2014-05-21
• Last updated: 2022-11-03
• Results posted: 2019-03-11

Locations

1 site across 1 country: Germany