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Long‐term (6 and 12 months) follow‐up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF‐200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis
Author(s) -
Dirschka T.,
Radny P.,
Dominicus R.,
Mensing H.,
Brüning H.,
Jenne L.,
Karl L.,
Sebastian M.,
OsterSchmidt C.,
Klövekorn W.,
Reinhold U.,
Tanner M.,
Gröne D.,
Deichmann M.,
Simon M.,
Hübinger F.,
Hofbauer G.,
KrähnSenftleben G.,
Borrosch F.,
Reich K.,
Berking C.,
Wolf P.,
Lehmann P.,
MoersCarpi M.,
Hönigsmann H.,
WernickePanten K.,
Hahn S.,
Pabst G.,
Voss D.,
Foguet M.,
Schmitz B.,
Lübbert H.,
Szeimies R.M.
Publication year - 2013
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.12158
Subject(s) - actinic keratosis , medicine , photodynamic therapy , placebo , clearance , gastroenterology , lesion , surgery , dermatology , urology , pathology , chemistry , alternative medicine , organic chemistry , basal cell
Summary Background Two phase III trials of photodynamic therapy (PDT) with BF‐200 ALA, a recently approved nanoemulsion formulation of 5‐aminolaevulinic acid (ALA) demonstrated high clearance rates in mild‐to‐moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates. Objectives To evaluate long‐term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF‐200 ALA, MAL or placebo. Methods The follow‐up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF‐200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT. Results Recurrence rates were similar for BF‐200 ALA and MAL, with a tendency to lower recurrence rates for BF‐200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF‐200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF‐200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported. Conclusions The FUP data confirmed the high efficacy and safety of PDT with BF‐200 ALA. The slightly lower recurrence rates after BF‐200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy.