WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK analysis.
A double-blind, single-centered, vehicle-controlled, randomized Phase IIa study of WBI-1001 on patients with mild to moderate Atopic Dermatitis (AD). All body areas were treatable except face, scalp, groin and genital areas. Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. Blood draws for PK analysis were taken weekly at the study centre prior to the morning cream application. Patients returned to the study centre approximately one week later for a follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.
Innovaderm Research Inc.,
Montreal, Quebec, Canada
To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients.
Time frame: 0, 7, 14, 21, 28 and 35 days
Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK.
Time frame: 0, 7, 14, 21 and 28 days
Explore efficacy of topically applied WBI-1001 cream in patients with AD.
Time frame: 0, 7, 14, 21, 28 and 35 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.