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| Sponsored by: |
LEO Pharma |
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00243464 |
Purpose
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
| Condition | Intervention | Phase |
|
Psoriasis of Scalp |
Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel) |
Phase III |
| MedlinePlus related topics: | Psoriasis |
| ChemIDplus related topics: | Calcipotriene Betamethasone Bentelan Betamethasone dipropionate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | May 2006 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contacts and Locations| Belgium | |||||
| Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie | |||||
| Leuven, Belgium, 3000 | |||||
| Canada, Ontario | |||||
| Windsor Clinical Research Inc. | |||||
| Windsor, Ontario, Canada, N8W5L7 | |||||
| Denmark | |||||
| Department of Dermatology, Marselisborg Centres | |||||
| Aarhus, Denmark, 8000 | |||||
| France | |||||
| Hôpital de L'Archet, Service de Dermatologie | |||||
| Nice, France, 06202 | |||||
| Sweden | |||||
| Läkarhuset | |||||
| Göteborg, Sweden, 41135 | |||||
| LEO Pharma |
| Principal Investigator: | Knud Kragballe, MD | Department of Dermatology, Marselisborg Centres |
More Information
| Study ID Numbers: | MBL 0503 INT |
| First Received: | October 21, 2005 |
| Last Updated: | August 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00243464 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Sweden: Medical Products Agency |
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