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Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.

NCT02799082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2017-04-06

Study results available
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Summary

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Vehicle

topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

DRUG

BF-200 ALA

topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Sponsors & Collaborators

  • Biofrontera Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Rolf-Markus Szeimies, Prof Dr · Klinikum der Universität Regensburg Klinik und Poliklinik für Dermatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-10-31
Completion
2008-10-31

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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 NCT02799082 on ClinicalTrials.gov