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Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream

2014-08-27 03:14:46 | BioPortfolio

Summary

Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mild to moderate atopic dermatitis.

Description

A multi-centered, double-blinded Phase IIb study to evaluate the safety and efficacy of the non-steroid, anti-inflammatory WBI-1001 cream in the topical treatment of patients with mild to moderate atopic dermatitis, expressed as lesions up to 20% BSA. For the first 6 weeks patients will be randomized to one of three treatment groups simultaneously in a ratio of 1:1:1.

Group 1: vehicle cream (placebo), BID; Group 2: 0.5% WBI-1001 cream, BID; Group 3:1.0% WBI-1001 cream, BID. Patients randomized to treat all lesion areas.

After the first 6 weeks all patients will be treated, non-placebo controlled, with WBI-1001 cream. The Group 1 patients will enter a double-blinded phase for a further 6 weeks with half of them being treated BID with 0.5% and half with 1.0% WBI-1001 cream. Groups 2 and 3 will continue with their treatments unchanged for the remaining 6 weeks.

During the treatment period, patients will apply the cream (BID) from the kit that they have been provided, and they will visit the study centre at prescribed times for assessment of efficacy, safety and tolerability. After completion of the 12-week treatment period patients will have a 2-week follow-up visit.

Patients who withdraw from the study before Day 42 for reasons other than a treatment related AE will be replaced so that at least 40 patients per group will complete the placebo-controlled phase.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Dermatitis, Atopic

Intervention

WBI-1001

Location

Guilford Dermatology Associates
Surrey
British Columbia
Canada
V3R 6A7

Status

Recruiting

Source

Welichem Biotech Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:46-0400

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