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
| Autor: | Mari Grönroos, Erna Snellman, Mari Salmivuori, Noora Neittaanmäki, L. Ylitalo, Lasse Ylianttila, Pekka Rissanen, J. Hagman, J.E. Räsänen |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Cost-Benefit Analysis medicine.medical_treatment Photodynamic therapy Dermatology Double blind Pain visual analogue scale 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Value for money Humans Medicine Prospective Studies 5 aminolaevulinic acid Aged Aged 80 and over Photosensitizing Agents business.industry Actinic keratosis Aminolevulinic Acid Middle Aged ta3122 medicine.disease Keratosis Actinic Treatment Outcome Photochemotherapy Tolerability Female business Clearance |
| Zdroj: | British Journal of Dermatology. 181:265-274 |
| ISSN: | 1365-2133 0007-0963 |
| Popis: | Background Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK). Objectives To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs. Methods This nonsponsored, 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 mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven 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 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. |
| Databáze: | OpenAIRE |
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