Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis (WBI-1001-101)

This study has been completed.
Sponsor:
Information provided by:
Welichem Biotech Inc.
ClinicalTrials.gov Identifier:
NCT00830817
First received: January 26, 2009
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized, Double-Blind Phase I Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Psoriasis.

Resource links provided by NLM:


Further study details as provided by Welichem Biotech Inc.:

Primary Outcome Measures:
  • Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood plasma samples retained following PK analyses.


Enrollment: 36
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Patients initiated screening within 4 weeks of commencing study treatment. Based on progression of the study, at day 0 patients were assigned to one of six treatment Cohorts. Patients were randomized to treat all areas except the face, scalp, groin and genital areas. Patients in Cohort 1 were treated on one side with a thin layer of active cream and the other with placebo; in the absence of significant AEs by 14 days after the last treatment in the Cohort escalation to the next Cohort was allowed, and each Cohort respectively.

During the treatment period patients visited the study centre weekly for safety, tolerability and efficacy assessment. On these study visit days blood draws were done between 7.00 and 10.00am prior to that morning's application of cream.

The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis of stable plaque psoriasis for >months affecting a maximum of 6% of BSA with a minimum of 0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side excluding elbow and knee.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830817

Locations
Canada, Quebec
Innovaderm Research inc.
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Welichem Biotech Inc.
Investigators
Study Chair: John m Webster, PhD, D.Sc. Welichem Biotech Inc.
Study Director: Liren Tang, Ph.D Welichem Biotech Inc.
  More Information

No publications provided

Responsible Party: Robert Bissonnette; Principal Investigator, Innovaderm Research, Inc.,
ClinicalTrials.gov Identifier: NCT00830817     History of Changes
Other Study ID Numbers: WBI-1001-101; control # 114963
Study First Received: January 26, 2009
Last Updated: January 27, 2009
Health Authority: Canada: Health Canada

Keywords provided by Welichem Biotech Inc.:
Topical cream application
Mild to moderate psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014