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

Basal Cell Carcinoma (BCC) Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02144077
Study type	Interventional
Source	Biofrontera Bioscience GmbH
Contact
Status	Completed
Phase	Phase 3
Start date	January 28, 2014
Completion date	September 9, 2020

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