Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
LEO Pharma |
---|---|
Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00243464 |
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 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
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 |
Principal Investigator: | Knud Kragballe, MD | Department of Dermatology, Marselisborg Centres |
Study ID Numbers: | MBL 0503 INT |
Study First Received: | October 21, 2005 |
Last Updated: | August 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00243464 History of Changes |
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 |
Betamethasone-17,21-dipropionate Anti-Inflammatory Agents Skin Diseases Hormone Antagonists Betamethasone sodium phosphate Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Glucocorticoids Hormones Calcipotriene Sodium phosphate Psoriasis Skin Diseases, Papulosquamous Betamethasone |
Betamethasone-17,21-dipropionate Anti-Inflammatory Agents Respiratory System Agents Skin Diseases Betamethasone sodium phosphate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones |
Glucocorticoids Pharmacologic Actions Calcipotriene Psoriasis Therapeutic Uses Dermatologic Agents Skin Diseases, Papulosquamous Betamethasone |