title: Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials.
abstract: Topical corticosteroids remain the first-line therapy for atopic dermatitis (AD). Hence, we investigated the efficacy and safety profile of a novel selective corticosteroid, GW870086. We performed 2 randomised, double-blind, controlled studies with 25 AD patients and 20 healthy subjects. The changes in the Three-Item Severity (TIS) score and the skin thickness were the primary end points, respectively. The adjusted TIS score (day 22) shows that the novel corticosteroid resulted in a non-significant, but dose-dependent reduction compared to placebo (GW870086 0.2% vs. placebo = -0.38, GW870086 2% vs. placebo = -0.89). Significant skin thinning was observed in the second study on days 14 and 21 when patients were treated with the comparator but not with the novel corticosteroid compared to placebo. The clinical efficacy of the new selective corticosteroid was not superior to placebo, although a dose-dependent improvement upon treatment was noticed without the onset of skin thinning.
authors.affiliation: Department of Dermatology and Allergology, Allergy-Centre-Charité, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Dölle
authors.forename: Nadine
authors.initials: N
authors.lastname: Hielscher
authors.forename: Philippe Jean
authors.initials: PJ
authors.lastname: Bareille
authors.forename: Kelly
authors.initials: K
authors.lastname: Hardes
authors.forename: Jonathan
authors.initials: J
authors.lastname: Robertson
authors.forename: Margitta
authors.initials: M
authors.lastname: Worm
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003876:Dermatitis, Atopic / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D012867:Skin / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D013256:Steroids / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; C581038:GW870086X; D013256:Steroids