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

January 27, 2009 updated by: Welichem Biotech Inc.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate safety and tolerability of topically applied WBI-1001 cream, and to assess the pharmacokinetics based on plasma concentrations
Time Frame: 35 days
35 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Welichem Biotech Inc.

Investigators

  • Study Chair: John m Webster, PhD, D.Sc., Welichem Biotech Inc.
  • Study Director: Liren Tang, Ph.D, Welichem Biotech Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBI-1001-101; control # 114963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe