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| Sponsored by: |
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:
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 |
| 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 |
| Estimated Enrollment: | 1032 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | December 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and 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 | |||||
| LEO Pharma |
| 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 |
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