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Background  The most effective treatment modality for actinic keratosis ( AK ) is photodynamic therapy ( PDT ). Major obstacles of  PDT  are the need of a special illumination device and pain accompanying the illumination. These issues may be overcome by replacing an artificial high‐power light source with natural daylight for more extended illumination at lower light doses.    Objective  To determine whether  BF ‐200  ALA  (a nanoemulsion gel containing 7.8% 5‐aminolaevulinic acid) is non‐inferior to  MAL  (a cream containing 16% methyl‐aminolaevulinate) in the treatment of mild‐to‐moderate  AK  with daylight  PDT  ( dPDT ). Non‐inferiority of the primary efficacy variable (total lesion clearance rate per patient's side 12 weeks after  PDT ) is established if the mean response for  BF ‐200  ALA  is no worse than for  MAL , within a statistical margin of Δ = −12.5%.    Methods  The study was performed as an intraindividual comparison with 52 patients in seven centres in Germany and Spain. Each patient received one dPDT. Results include clinical endpoints as well as 1‐year follow‐up results.    Results  Twelve weeks after a single  dPDT , 79.8% of the  AK  lesions treated with  BF ‐200  ALA  gel and 76.5% of the lesions treated with  MAL  cream were completely cleared. The median of differences was 0.0 with a one‐sided 97.5%  CI  of 0.0, establishing non‐inferiority ( P  < 0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 1 year after the treatment were 19.9% for lesions treated with  BF ‐200  ALA  and 31.6% for lesions treated with  MAL . Adverse reactions including pain were mostly mild and transient and identical to those previously described for  dPDT .    Conclusion  Daylight  PDT  of  AK  with  BF ‐200  ALA  is well‐tolerated and non‐inferior to  MAL /dPDT. The study demonstrates a trend towards higher efficacies after 3 months and significantly lower recurrence rates after 1 year follow‐up.

journal of the european academy of dermatology and venereology

A randomized, intraindividual, non‐inferiority, Phase  III  study comparing daylight photodynamic therapy with  BF ‐200  ALA  gel and  MAL  cream for the treatment of actinic keratosis