Bissonnette R. Brit J Derm. 2012; doi: 10.1111/j.1365-2133.2011.10775.x.
Two formulations of WBI-1001, a novel topical treatment for atopic dermatitis, yielded encouraging efficacy and safety profiles, according to study results.
Researchers conducted the study to investigate potential nonsteroidal topical therapy options for the treatment of atopic dermatitis.
The study drug was WBI-1001. The primary outcome measure was the efficacy of this drug in the treatment of mild to severe atopic dermatitis during 6 weeks of therapy.
Eligible patients had disease which affected 3% to 20% of their body surface area and an Investigator’s Global Assessment of 2–4.
The full analysis included 148 patients randomly assigned one of three treatment regimens in a 1:1:1 fashion. Fifty-one patients were assigned placebo, 50 were assigned 0.5% WBI-1001 and 47 were assigned 1.0% WBI-1001 in a cream formulation. Treatment was applied twice daily for 6 weeks.
At the end of this phase, patients receiving the study drug continued treatment for another 6-week period. Patients in the placebo group entered a 6-week double-blind phase in which they were re-randomized in a 1:1 ratio to the 0.5% or 1.0% WBI-1001 formulation.
The researchers evaluated for the mean change in Investigator’s Global Assessment from baseline to day 42.
Day 42 results indicated a decrease in mean Investigator’s Global Assessment of 1.3 (43%; 95% CI, −1.2 to −0.5) among patients in the WBI-1001 0.5% group and of 1.8 (56.3%; 95% CI, −1.6 to −0.9) among those in the WBI-1001 1.0% group. Comparatively, a decrease of 0.5 (14.7%) was observed in the placebo group.
Adverse event profiles indicated a few cases of folliculitis and contact dermatitis, according to the results.