MIAMI — A substituted trans-stilbene derivative known as WBI-1001, which showed promise for the topical treatment of atopic dermatitis in preclinical studies, was safe and effective for mild to moderate disease in a small double-blind, randomized, vehicle-controlled study.
A total of 36 patients aged 18-65 years with chronic mild to moderate atopic dermatitis were randomized to apply either 0.5% WBI-1001 cream, 1.0% cream, or vehicle cream twice daily for 4 weeks.
At 1-week follow-up, the two treatment groups had significant reductions in Eczema Area and Severity Index (EASI) scores, compared with the vehicle group, with score reductions of 59.3% and 54.9% in the 0.5% and 1.0% groups, respectively, versus a 7.1% reduction in the vehicle group, Dr. Youwen Zhou reported during a poster discussion session at the annual meeting of the American Academy of Dermatology.
Similar improvements were seen in Severity Scoring of Atopic Dermatitis Severity Index (SCORAD) scores, Investigator Global Assessment (IGA) scores, body surface area (BSA) affected, and pruritis; in the 0.5% and 1.0% treatment groups vs. the vehicle group, respectively, SCORAD scores decreased 56.2% and 50.1% vs. 18.4%; IGA scores decreased by 38.9% and 45.8% vs. 5.6%; body surface area affected decreased by 64.4% and 57.7% vs. 1.08%; and pruritis scores decreased by 74% and 56% vs. 25%.
At 4-week follow-up, half of the patients in the treatment groups were clear or almost clear, compared with only 16.7% of those in the vehicle group, said Dr. Zhou of the University of British Columbia, Vancouver.
No treatment-related adverse events were seen in this study, no drug accumulation was reported, and no detectable drug was found in 76% of plasma samples, indicating that there was only minimal absorption into the blood system, Dr. Zhou said.
This is an early-stage clinical trial, but the findings suggest that the novel nonsteroidal anti-inflammatory WBI-1001 compound has promise for the treatment of mild to moderate atopic dermatitis, he concluded.
He noted that, except for pruritis, which occurred less often in the 0.5% treatment group, the 0.5% and 1.0% doses had similar outcomes that were significantly better than those seen in the vehicle arm.
The study was supported by Welichem Biotech Inc. Dr. Zhou is a paid consultant for Welichem Biotech.