CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 571 enrolled
Drug / intervention
BF-200 ALA +2 moredrug
Likely dose
BF-200 ALA topical nanoemulsion gel, applied once followed by 3-hour incubation and illumination with broad or narrow spectrum light sourceAI-extracted
Key inclusion· 8
  • ✓Age 18-85 years
  • ✓4-8 actinic keratosis lesions of 0.5-1.5 cm diameter, mild to moderate intensity (Olsen grade 1-2) on face or bald scalp
  • ✓Biopsy confirmation of actinic keratosis at screening
  • ✓Free of significant physical abnormalities in treatment region that could impair examination or evaluation
Key exclusion· 9
  • ✕Known hypersensitivity to BF-200 ALA, MAL, or formulation ingredients
  • ✕Clinically significant medical conditions (e.g., tumor disease) that would make protocol implementation or result interpretation difficult
  • ✕Presence of photodermatoses
  • ✕Other tumors in treatment areas within last 4 weeks

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

Search/NCT02799069
NCT02799069Phase 3Completed
CompareCT.gov

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of a Nanoemulsion Gel Formulation BF-200 ALA, in Comparison With Metvix® and Placebo, for the Treatment of Actinic Keratosis With PDT

Biofrontera Bioscience GmbH·interventional·Posted Jun 14, 2016·Updated Apr 28, 2017

In Brief

A Phase 3 clinical trial evaluating BF-200 ALA, MAL Cream, and 1 other intervention for Actinic Keratosis. Completed, enrolled 571 participants.

Detailed Summary

The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
Countries--
CollaboratorsAccovion GmbH

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2016
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

BF-200 ALAdrug

topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

MAL Creamdrug

topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Vehicledrug

topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.