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

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ClinicalTrials.gov Identifier: NCT00830817
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Psoriasis

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.


Study Design

Study Type : Observational
Actual Enrollment : 36 participants
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.
Study Start Date : July 2007
Primary Completion Date : April 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Secondary Outcome Measures :
  1. Obtain initial evaluation of efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. [ Time Frame: 35 days ]

Biospecimen Retention:   Samples Without DNA
Blood plasma samples retained following PK analyses.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

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

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