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NCT00216892 Clinical Trial

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

Psoriasis Vulgaris Clinical Trial

Official title:
Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00216892
Other study ID # MCB 0402 INT
Secondary ID
Status Completed
Phase Phase 4
First received September 15, 2005
Last updated March 25, 2015
Start date April 2005
Est. completion date December 2005

Study information
Verified date March 2015
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: Dutch Health Care InspectorateSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 1032
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Calcipotriol, (calcipotriol + betamethasone)

Locations
Country Name City State
Belgium Universitair Ziekenhuis Gent
Canada Dermatrials Research Dermatology Centre Hamilton Ontario
France Hôpital Nord, Service de Dermatologie Saint Etienne
Germany Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie Frankfurt
Netherlands Canisius-Wilhelmina Ziekenhuis Nijmegen
Spain Hospital Mutua de Terrassa Dermatology Service Terrassa
United Kingdom Clatterbridge Hospital, Department of Dermatology Merseyside

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
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)
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