Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris - Full Text View

Purpose

Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
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

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: Calcipotriol, (calcipotriol + betamethasone)	Phase IV

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Calcipotriene Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by LEO Pharma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1032
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216892

Locations


Belgium
	Universitair Ziekenhuis
	Gent, Belgium, 9000

Canada, Ontario
	Dermatrials Research Dermatology Centre
	Hamilton, Ontario, Canada, L8N 1V6

France
	Hôpital Nord, Service de Dermatologie
	Saint Etienne, France, 42055

Germany
	Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie
	Frankfurt, Germany, 60590

Netherlands
	Canisius-Wilhelmina Ziekenhuis
	Nijmegen, Netherlands, 6532

Spain
	Hospital Mutua de Terrassa Dermatology Service
	Terrassa, Spain, 08221

United Kingdom
	Clatterbridge Hospital, Department of Dermatology
	Merseyside, United Kingdom, L63 4JY

Sponsors and Collaborators

LEO Pharma

Investigators


Principal Investigator:	S White, MD	Clatterbridge Hospital, Department of Dermatology

More Information

Study ID Numbers:	MCB 0402 INT
First Received:	September 15, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00216892
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Dutch Health Care Inspectorate; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Calcipotriene

Betamethasone-17,21-dipropionate

Sodium phosphate

Skin Diseases

Psoriasis

Betamethasone sodium phosphate

Betamethasone

Skin Diseases, Papulosquamous

Calcitriol

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Molecular Mechanisms of Pharmacological Action

Growth Substances

Calcium Channel Agonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Bone Density Conservation Agents

Cardiovascular Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Membrane Transport Modulators

Therapeutic Uses

Vitamins

Vasoconstrictor Agents

Micronutrients

Dermatologic Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	LEO Pharma
Information provided by:	LEO Pharma
ClinicalTrials.gov Identifier:	NCT00216892