Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Phase 4

Completed

• Conditions: Psoriasis Vulgaris

• Registration Number: NCT00216892
• Lead Sponsor: LEO Pharma

Brief 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

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

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-22
• Study Completion: 2005-12
• Status Verified: 2015-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1032

Inclusion Criteria

• Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12

Secondary Outcome Measures

Name	Time	Method
Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)

Trial Locations

Locations (7)

Universitair Ziekenhuis; 🇧🇪 Gent, Belgium

Dermatrials Research Dermatology Centre; 🇨🇦 Hamilton, Ontario, Canada

Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie; 🇩🇪 Frankfurt, Germany

Canisius-Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Hôpital Nord, Service de Dermatologie; 🇫🇷 Saint Etienne, France

Hospital Mutua de Terrassa Dermatology Service; 🇪🇸 Terrassa, Spain

Clatterbridge Hospital, Department of Dermatology; 🇬🇧 Merseyside, United Kingdom