Status:
COMPLETED
Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis
Lead Sponsor:
Welichem Biotech Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
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-blin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00830817
Start Date
July 1 2007
End Date
June 1 2008
Last Update
January 28 2009
Active Locations (1)
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1
Innovaderm Research inc.
Montreal, Quebec, Canada, H2K 4L5