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Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy

NCT02799069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2017-04-28

Study results available
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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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

BF-200 ALA

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

DRUG

MAL Cream

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

DRUG

Vehicle

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

Sponsors & Collaborators

  • Accovion GmbH

    collaborator INDUSTRY

  • Biofrontera Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Dirschka, Prof. Dr. · Akademische Lehrpraxis der Universität Witten-Herdecke Heinz-Fangman-Straße 57 42287 Wuppertal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-08-31
Completion
2009-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799069 on ClinicalTrials.gov