Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

Summary

This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.

Timeline

Start

2015-06

Primary completion

2017-10

Completion

2017-10

Outcome

Met primary endpoint

paper In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0·008). PMID 30329163 ↗

Publications

• Results Rasanen JE, Neittaanmaki N, Ylitalo L, Hagman J, Rissanen P, Ylianttila L, Salmivuori M, Snellman E, Gronroos M. 5-aminolaevulinic acid nanoemulsion is more effective than methyl-5-aminolaevulinate in daylight photodynamic therapy for actinic keratosis: a nonsponsored randomized double-blind multicentre trial. Br J Dermatol. 2019 Aug;181(2):265-274. doi: 10.1111/bjd.17311. Epub 2019 Jan 2.

Drugs

Indications