Actinic Keratosis Clinical Trial
Official title:
A Randomized Placebo-controlled Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis
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).
The study was performed to define the effective therapeutic dose of the active
pharmaceutical ingredient (ALA) in a nanoemulsion formulation in the treatment of actinic
keratosis (AK) with topical PDT and to assess the efficacy of topical PDT with a new
nanoemulsion formulation of ALA in the treatment of AK. The efficacy of BF-200 ALA was
calculated by the AK clearance rate, defined as the proportion of AK lesions showing
complete remission 12 weeks after PDT treatment.
Subjects of two study centres provided plasma and urine samples for the quantification of
ALA and its metabolite, the active photosensitizer protoporphyrin IX (PpIX).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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