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

Background There is a need for the development of navel 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; 950 CI -1.6 to -0.9) in IGA at day 42 in the WBI-1001 0.5 A; 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.