A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis. (WBI-1001-201)

NCT00837551 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Welichem Biotech Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	36
Start date	2008-03
Completion	2008-10

Conditions

• Dermatitis, Atopic

Interventions

• WBI-1001

Primary outcomes

• To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients. — 0, 7, 14, 21, 28 and 35 days

Countries

Canada