Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with: 1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream 2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on...
Date First Received: September 15, 2005
Last Updated: February 20, 2008
Verified by: LEO Pharma, February 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 1032
Brief Summary
Official Title: “Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:
1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream
The objective is to compare the efficacy and safety of the different treatment regimens
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial Description
A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris
Intervention(s) in this Clinical Trial
- Drug: Calcipotriol, (calcipotriol + betamethasone)
Outcome Measures for this Clinical Trial
Primary Measures
- Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
Secondary Measures
- Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with psoriasis vulgaris of trunk and/or limbs
Exclusion Criteria:
-
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Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: LEO Pharma
Overall Clinical Trial Officials and Contacts
S White, MD Principal Investigator Clatterbridge Hospital, Department of Dermatology
Additional Information
Information obtained from ClinicalTrials.gov on September 07, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00216892
Study ID Number: MCB 0402 INT
ClinicalTrials.gov Identifier: NCT00216892
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
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