Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Information source: LEO Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis Vulgaris
Intervention: Calcipotriol, (calcipotriol + betamethasone) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: LEO Pharma Official(s) and/or principal investigator(s):
S White, MD, Principal Investigator, Affiliation: Clatterbridge Hospital, Department of Dermatology
Summary
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
Clinical Details
Official title: Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
Secondary outcome: Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)
Detailed 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with psoriasis vulgaris of trunk and/or limbs
Exclusion Criteria:
-
Locations and Contacts
Universitair Ziekenhuis, Gent 9000, Belgium
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
Dermatrials Research Dermatology Centre, Hamilton, Ontario L8N 1V6, Canada
Additional Information
Starting date: April 2005
Ending date: December 2005
Last updated: February 20, 2008
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