NCT00837551

Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Welichem Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	WBI-1001	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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2009-02-05
• Last updated: 2009-02-05

Locations

1 site across 1 country: Canada