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A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis

NCT02799030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-07-19

No results posted yet for this study

Summary

This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).

Conditions

  • Actinic Keratosis

Interventions

DRUG

BF-200 ALA 1%

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

DRUG

BF-200 ALA 3%

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

DRUG

BF-200 ALA 10%

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

Sponsors & Collaborators

  • Biofrontera Bioscience GmbH

    lead INDUSTRY

Principal Investigators

  • Rolf-Markus Szeimies, Prof Dr · Klinikum der Universität Regensburg Klinik und Poliklinik für Dermatologie Franz-Josef-Strauß-Allee 11

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-03-31
Completion
2007-03-31

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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 NCT02799030 on ClinicalTrials.gov