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Topical resiquimod dosing regimens in patients with multiple actinic keratoses: a multicentre, partly placebo‐controlled, double‐blind clinical trial
Author(s) -
Stockfleth E.,
Hofbauer G.F.L.,
Reinhold U.,
Popp G.,
Hengge U.R.,
Szeimies R.M.,
Brüning H.,
Anliker M.,
Hunger T.,
Dummer R.,
Ulrich C.,
Kenzelmann R.,
Surber C.,
French L.E.
Publication year - 2019
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.17124
Subject(s) - tolerability , dosing , medicine , placebo , adverse effect , clinical trial , clinical endpoint , randomized controlled trial , gastroenterology , surgery , pathology , alternative medicine
Summary Background Topical immune response modifiers are established for actinic keratosis ( AK ) treatment and efforts are underway to make further improvements to their efficacy and safety. Objectives To investigate the optimal dosing regimens of the Toll‐like receptor 7/8 agonist resiquimod in terms of efficacy, safety and tolerability. Methods In a multicentre, partly placebo‐controlled, double‐blind clinical trial, we randomized 217 patients with AK lesions to 0·03% resiquimod gel once‐daily application three times per week for 4 weeks or seven times within 2 weeks or five times for 1 week (arms 1/2/3) followed by a treatment‐free interval of 8 weeks and one repetition of the cycle. In two additional arms (arms 4/5), patients applied either resiquimod gel 0·01% or 0·03% three times per week up to a biological end point defined by skin erosion or for a maximum duration of 8 weeks. Clearance was assessed clinically and histologically. Results Complete clinical clearance ranged from 56% to 85% with the highest rate observed in arm 2. Resiquimod 0·03% gel was more effective than 0·01% gel. Clearance rates in arms 1/2/3 were comparable and higher than with placebo and were reached with 24, 14 and 10 gel applications, respectively. Overall, 128 patients (59%) experienced treatment‐related adverse reactions. Conclusions Resiquimod 0·03% gel is more effective than 0·01% gel. From the perspectives of safety and tolerability, the lower concentration and shorter duration are preferable. The clinical response in arms 2/3 was reached with fewer gel applications. The dosing regimens that used the biological end point (arms 4/5) proved equally efficacious as predefined treatment durations and may therefore be suitable for personalized AK treatment.