Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials

Skin Pharmacol Physiol. 2015;28(3):159-66. doi: 10.1159/000367696. Epub 2015 Jan 20.

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.

Trial registration: ClinicalTrials.gov NCT00549497.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenal Cortex Hormones / blood
  • Adrenal Cortex Hormones / pharmacokinetics
  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Aged
  • Cross-Over Studies
  • Dermatitis, Atopic / blood
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Humans
  • Middle Aged
  • Skin / diagnostic imaging
  • Skin / drug effects
  • Skin / pathology
  • Steroids / blood
  • Steroids / pharmacokinetics
  • Steroids / therapeutic use*
  • Treatment Outcome
  • Ultrasonography
  • Young Adult

Substances

  • Adrenal Cortex Hormones
  • GW870086X
  • Steroids

Associated data

  • ClinicalTrials.gov/NCT00549497