Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis

NCT00830817 | Completed DMC

• 1 other identifier: WBI-1001-101; control # 114963
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Psoriasis

Keywords

Topical cream application; Mild to moderate psoriasis

Outcome Measures

Primary Outcomes (1)

• Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations

  35 days

Secondary Outcomes (1)

• Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis.

  35 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and female18-65 yo. inclusive Mild to moderate plaque psoriasis

You may qualify if:

• PGA score at day 0 must be 2,3 or 4.
• In good overall health.
• Women of child bearing potential to have negative serum beta-human chorionic gonadotropin pregnancy test before randomization
• Must be prepared to use adequate means of contraception
• Must not be lactating.
• Male partners of females in the study must be prepared to use adequate means of contraception.
• Must comply with study protocol and attend all visits.
• Provide written consent prior to participating in the study.

You may not qualify if:

• Spontaneously improving or rapidly deteriorating psoriasis.
• Patients with other diseases (especially dermatological, immunodeficiency or neurological/psychiatric) that might interfere with assessment of plaque psoriasis.
• Systemic immunomodulatory therapy in past 36 weeks, phototherapy in past 4 weeks, various psoriatic chemotherapies and beta blockers in the past 2 weeks

Sponsors & Collaborators

• Welichem Biotech Inc.: lead

Study Sites (1)

Innovaderm Research inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma samples retained following PK analyses.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John m Webster, PhD, D.Sc.

  Welichem Biotech Inc.

  STUDY CHAIR

• Liren Tang, Ph.D

  Welichem Biotech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

CA (1)