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

NCT01098734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2011-06-13

No results posted yet for this study

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

WBI-1001

A 12-week study to assess the efficacy, safety and tolerability of topically applied WBI-1001 creams. First 6 weeks will be double-blinded, placebo-controlled and the following 6 weeks will be double-blinded, non-placebo- controlled. After 6 weeks patients in Groups 2 and 3 will continue double-blinded treatment for a further 6 weeks, but patients in Group 1 will enter a 6-week double-blinded phase with one of the two active creams (half treated with 0.5% and half with 1.0% WBI-1001 cream). All patients treated twice daily (BID).

Sponsors & Collaborators

  • Welichem Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Liren Tang, Ph.D · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098734 on ClinicalTrials.gov