CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 281 enrolled
Drug / intervention
BF-200 ALA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02144077
NCT02144077Phase 3Completed
CompareCT.gov

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)

Biofrontera Bioscience GmbH·interventional·Posted May 21, 2014·Updated Nov 3, 2022

In Brief

A Phase 3 clinical trial evaluating BF-200 ALA and methyl-aminolevulinate for Basal Cell Carcinoma (BCC). Completed, enrolled 281 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Carcinoma (BCC)
CountriesGermany
CollaboratorsAccovion GmbH

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2014
Enrollment StartJan 28, 2014
Primary CompletionNov 17, 2015
Study CompletionSep 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.1 years ago

Interventions

BF-200 ALAdrug

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

methyl-aminolevulinatedrug

Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)