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):
Intervention(s):
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Outcome Measures for this Clinical Trial
Primary:
- Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
Secondary:
- 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:
-
-
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: LEO Pharma
Universitair Ziekenhuis
Gent 9000 Belgium
Dermatrials Research Dermatology Centre
Hamilton Ontario L8N 1V6 Canada
Hôpital Nord, Service de Dermatologie
Saint Etienne 42055 France
Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie
Frankfurt 60590 Germany
Canisius-Wilhelmina Ziekenhuis
Nijmegen 6532 Netherlands
Hospital Mutua de Terrassa Dermatology Service
Terrassa 08221 Spain
Clatterbridge Hospital, Department of Dermatology
Merseyside L63 4JY United Kingdom
Overall Clinical Trial Officials and Contacts
S White, MD Principal Investigator Clatterbridge Hospital, Department of Dermatology
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
