Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis
NCT00830817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36
Last updated 2009-01-28
Summary
The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and AUCo-t.
Conditions
Sponsors & Collaborators
-
Welichem Biotech Inc.
lead INDUSTRY
Principal Investigators
-
John m Webster, PhD, D.Sc. · Welichem Biotech Inc.
-
Liren Tang, Ph.D · Welichem Biotech Inc.
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2008-04-30
- Completion
- 2008-06-30
Countries
- Canada
Study Locations
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