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About
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.
Full description
This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-[5-amino-4-oxopentanoate]) and placebo, for the treatment of AK with PDT.
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Inclusion and exclusion criteria
Main Inclusion Criteria:
Main exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
571 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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