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Daylight photodynamic therapy for actinic keratoses: a randomized double‐blinded nonsponsored prospective study comparing 5‐aminolaevulinic acid nanoemulsion ( BF ‐200) with methyl‐5‐aminolaevulinate
Author(s) -
NeittaanmäkiPerttu N.,
Karppinen T.T.,
Grönroos M.,
Tani T.T.,
Snellman E.
Publication year - 2014
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.13326
Subject(s) - actinic keratoses , photodynamic therapy , dermatology , daylight , medicine , photosensitivity , randomized controlled trial , chemistry , optics , organic chemistry , physics
Summary Background Daylight‐mediated photodynamic therapy ( DL ‐ PDT ) using methyl‐5‐aminolaevulinate ( MAL ) is effective for thin, grade I, actinic keratoses ( AK ). There are no published studies of other photosensitizers used in DL ‐ PDT . Objectives To compare the efficacy and adverse effects of 5‐aminolaevulinic acid nanoemulsion ( BF ‐200 ALA ) with MAL in DL ‐ PDT of grade I– III AK s. Methods In 13 patients, 177 AK s were randomized symmetrically for a split‐face prospective observer‐blinded study and received either BF ‐200 ALA or MAL DL ‐ PDT . Grade I AK s were treated once and grade II – III AK s twice with a 0·25‐mm layer of photosensitizer precursors. Pain was assessed during and after the daylight exposure. Efficacy at 3 months was assessed clinically and histologically. Results BF ‐200 ALA cleared 71/84 (84·5%) and MAL 69/93 (74·2%) of the AK s ( P = 0·099), all grades responding equally, but with new AK s appearing during follow‐up ( n = 4, BF ‐200 ALA ; n = 8, MAL ). In per patient half‐face analysis BF ‐200 ALA showed significantly higher clearance rates for grade I AK s than did MAL ( P = 0·027), but for thicker grades, clearance was equal ( P = 0·564). BF ‐200 ALA and MAL treatments resulted in 61·5% and 38·5% complete histological clearance ( P = 0·375), respectively. p53 expression decreased by 54·4% and 33·7%, respectively ( P = 0·552). Both treatments were nearly painless with similar adverse reactions and no difference in patient preference. Conclusions BF ‐200 ALA showed a trend towards improved efficacy results compared with MAL . Thicker lesions in both groups responded when treated repeatedly. Importantly, a thin 0·25‐mm layer of the photosensitizer precursors was sufficient, which may lead to lower expense.