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.

Emerging corticosteroid agonists for the treatment of asthma

“…In clinical trials, GW870086 has been studied in an inhaled formula on 36 mild to moderate asthmatics in a Phase II study [64], but no effect compared to placebo was found in change of FEV1. In two different trials investigating atopic dermatitis, a lack of effect was also present [66]. In another study of 136 asthmatics, not yet published, an effect on FEV1 was found in all study arms of patients using GW870086 (clinicaltrials.gov ID: NCT01245426).…”

“…It has been designed and studied aiming for treatment of respiratory [63,64], ophthalmological [65] as well as dermatological [66] diseases. This drug is a classical steroidal molecule, modified at the 17-a position, a feature shared by the relatively newly approved ICS, FF [63].…”

Compound traditional Chinese medicine dermatitis ointment ameliorates inflammatory responses and dysregulation of itch-related molecules in atopic dermatitis

“…Furthermore, overexpression of phosphorylation of ERK, JNK, p38, and p65 may accelerate the AD symptoms [ 8 ]. The current strategies in the treatment of AD include topical application of emollients, corticosteroids, calcineurin inhibitors, phototherapy, oral administration of steroids and immunosuppressants, and biologics [ 9 ]. However, these treatment modalities usually accompanied with side effects and drug tolerance.…”