Efficacy and safety of topical WBI-1001 in patients with mild to severe atopic dermatitis: results from a 12-week, multicentre, randomized, placebo-controlled double-blind trial.

Abstract

BACKGROUND:

There is a need for the development of novel nonsteroidal topical drugs for the treatment of atopic dermatitis (AD).

OBJECTIVES:

The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD.

METHODS:

  Patients with AD affecting 3-20% of their body surface area and with an Investigator's Global Assessment (IGA) of 2-4 were randomized (1 : 1 : 1) to receive placebo, WBI-1001 0·5% or WBI-1001 1·0% in a cream formulation applied twice daily for 6 weeks. At the end of this phase, patients receiving WBI-1001 continued the same treatment for an additional 6 weeks. Patients receiving placebo entered into a 6-week double-blind phase with re-randomization (1 : 1) to WBI-1001 0·5% or 1·0% cream. The primary objective was to evaluate the efficacy of WBI-1001 over 6 weeks of treatment of mild to severe AD. The primary endpoint was the mean change from baseline in IGA at day 42 (week 6).

RESULTS:

In total, 148 patients were randomized and analysed in the placebo (51), WBI-1001 0·5% (50) and WBI-1001 1·0% (47) groups. There was a decrease of 1·3 [43%; P < 0·001; 95% confidence interval (CI) -1·2 to -0·5] and 1·8 (56·3%; P < 0·001; 95% CI -1·6 to -0·9) in IGA at day 42 in the WBI-1001 0·5% and 1·0% groups, respectively, as compared with a decrease of 0·5 (14·7%) in the placebo group. Adverse drug reactions included a few cases of folliculitis and contact dermatitis.

CONCLUSIONS:

WBI-1001 is an efficacious novel topical anti-inflammatory molecule for the treatment of AD.

• Authors: R Bissonnette, Y Poulin, Y Zhou, J Tan, H C Hong, J Webster, W Ip, L Tang, M Lyle
• Journal: The British journal of dermatology (Br J Dermatol) Vol. 166 Issue 4 Pg. 853-60 (Apr 2012) ISSN: 1365-2133 [Electronic] England
• PMID: 22182053 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011.

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Ointments
• Resorcinols
• Stilbenes
• tapinarof

Topics

• Administration, Cutaneous
• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Chronic Disease
• Dermatitis, Atopic (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Eczema (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Ointments
• Resorcinols (administration & dosage, adverse effects)
• Severity of Illness Index
• Stilbenes (administration & dosage, adverse effects)
• Treatment Outcome
• Young Adult