Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)

Summary

The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.

Timeline

Start

2013-08

Primary completion

2014-12

Completion

2014-12

Outcome

Missed primary endpoint

registry BF-200 ALA: 61.5 percentage of complete clearance NCT01893203 ↗

registry analysis (superiority or other test); BF200 ALA vs MAL; p = 0.375; McNemar NCT01893203 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BF-200 ALA	Unknown	2 g	Topical
Subject	methyl aminolevulinate	Small molecule	2 g	Topical

Indications