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

January 26, 2009
January 27, 2009
July 2007
April 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00830817 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis
A Randomized, Double-Blind Phase I Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Psoriasis.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood plasma samples retained following PK analyses.

Non-Probability Sample

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

Psoriasis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00830817
WBI-1001-101; control # 114963
Yes
Robert Bissonnette; Principal Investigator, Innovaderm Research, Inc.,
Welichem Biotech Inc.
Not Provided
Study Chair: John m Webster, PhD, D.Sc. Welichem Biotech Inc.
Study Director: Liren Tang, Ph.D Welichem Biotech Inc.
Welichem Biotech Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP