03053nas a2200253 4500008004100000245016200041210006900203260001200272300001000284490000700294520220900301653001402510653001902524653001502543653001402558653002202572653002702594100002202621700001702643700002002660700001702680700002502697856007702722 2019 eng d00aHigh efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial0 aHigh efficacy of a dimeticonebased pediculicide following a brie c10-2019 a14 pp0 v193 a

Background:Increasing resistance of head lice against neurotoxic agents and safety concerns have led to thesearch for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk forthe development of resistance.

Methods:We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-basedproduct, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either adimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group).Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and localtolerability at baseline, and days 1, 7, and 10.

Results:After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in thein vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinicaltrial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application,98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants inboth groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverseevents (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild

.Conclusions:We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of abrief application of a new dimeticone-based product. The short application time and reduced risk for thedevelopment of resistance are key drivers for improved patients’compliance.

Trial registration:EU Clinical Trials Register EudraCT2016–004635-20. Registered 14 November 2016.

10abody lice10aClinical trial10aDimeticone10ahead lice10aOvicidal activity10aPediculicidal activity1 aHeukelbach, Jörg1 aWolf, Doerte1 aClark, Marshall1 aDautel, Hans1 aRoeschmann, Kristina uhttps://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-019-0094-4