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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00216892 History of Changes
Other Study ID Numbers:	MCB 0402 INT
Study First Received:	September 15, 2005
Last Updated:	February 20, 2008
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

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012