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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00830817
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : January 28, 2009
Information provided by:
Welichem Biotech Inc.

January 26, 2009
January 28, 2009
January 28, 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 ]
Same as current
No Changes Posted
Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. [ Time Frame: 35 days ]
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 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 Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Blood plasma samples retained following PK analyses.
Non-Probability Sample
Males and female18-65 yo. inclusive Mild to moderate plaque psoriasis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
WBI-1001-101; control # 114963
Not Provided
Not Provided
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