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A randomized, double‐blind, phase III , multicentre study to evaluate the safety and efficacy of BF ‐200 ALA (Ameluz ® ) vs. placebo in the field‐directed treatment of mild‐to‐moderate actinic keratosis with photodynamic therapy (PDT) when using the BF ‐Rhodo LED ® lamp
Author(s) -
Reinhold U.,
Dirschka T.,
Ostendorf R.,
Aschoff R.,
Berking C.,
PhilippDormston W.G.,
Hahn S.,
Lau K.,
Jäger A.,
Schmitz B.,
Lübbert H.,
Szeimies R.M.
Publication year - 2016
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.14498
Subject(s) - placebo , medicine , actinic keratosis , adverse effect , double blind , randomized controlled trial , photodynamic therapy , clinical trial , gastroenterology , urology , surgery , nuclear medicine , pathology , chemistry , alternative medicine , basal cell , organic chemistry
Summary Background Multiple actinic keratosis ( AK ) lesions may arise from the cancerization of large, sun‐damaged skin areas. Although photodynamic therapy ( PDT ) is considered the most effective therapeutic option, the efficacy and safety of field treatment of multiple AK lesions with PDT has never before been tested in a pivotal trial. Objectives To evaluate the efficacy, safety and cosmetic outcome of BF ‐200 ALA (a nanoemulsion formulation containing 10% aminolaevulinic acid hydrochloride) combined with the BF ‐Rhodo LED ® lamp for the field‐directed treatment of mild‐to‐moderate AK with PDT . Methods The study was performed as a randomized, multicentre, double‐blind, placebo‐controlled, parallel‐group, phase III trial with BF ‐200 ALA and placebo in seven centres in Germany. A total of 94 patients were enrolled in this study; 87 were randomized (55 patients received BF ‐200 ALA , 32 received placebo). Patients received one PDT . If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF ‐Rhodo LED (635 nm ± 9 nm) until a total light dose of 37 J cm −2 was achieved. Results BF ‐200 ALA was superior to placebo with respect to patient complete clearance rate (91% vs. 22%, P < 0·0001) and lesion complete clearance rate (94·3% vs. 32·9%, P < 0·0001) after a maximum of two PDT s. The confirmatory analysis of all key secondary variables supported this superiority” should not be skipped since this is an important result. Treatment‐emergent adverse events ( TEAE s) were experienced by 100% of the BF ‐200 ALA group and 69% of the placebo group. The most commonly reported TEAE s were TEAE s of the application site. The cosmetic outcome was improved in the BF ‐200 ALA group compared with placebo. Conclusions Field‐directed therapy with BF ‐200 ALA and BF ‐Rhodo LED lamp is highly effective and well tolerated for multiple mild‐to‐moderate AK lesions, providing greatly improved skin quality.