5-aminolevulinic acid nanoemulsion (BF-200 ALA) is more effective than methyl-5-aminolevulinate (MAL) in daylight photodynamic therapy for actinic keratosis: A non-sponsored randomized double-blind multicentre trial.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK).

OBJECTIVES: To assess the clinical efficacy, tolerability and cost-effectiveness of BF-200 ALA compared with MAL in DL-PDT for grade I-II AKs.

METHODS: This non-sponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy.

RESULTS: 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). In total, BF-200 ALA cleared 299/375 AKs (79.7%) and MAL 288/392 (73.5%) (p=0.041). The treatment was practically painless with both photosensitizers, the pain VAS being 1.51 for BF-200 ALA and 1.35 for MAL (p=0.061). 26 patients had a stronger skin reaction on the BF-200 ALA side, 7 on the MAL side and 23 displayed no difference (p=0.001). The cosmetic outcome was excellent or good in >90% of cases with both photosensitizers (p=1.000). The cost-effectiveness (CE)-plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA.

CONCLUSIONS: Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL. This article is protected by copyright. All rights reserved.