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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00216879 |
The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.
The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.
Condition | Intervention | Phase |
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Psoriasis of Scalp |
Drug: Calcipotriol plus betamethasone dipropionate gel (LEO 80185) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel |
Estimated Enrollment: | 800 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Clinique de Dermatologie | |
Moncton, Canada, E1C 8X3 | |
Denmark | |
Hørsholm Hospital, Dermatological Department | |
Hørsholm, Denmark, 2970 | |
France | |
Hôpital Nord, Service de Dermatologie | |
Saint-Etienne, France, 42055 | |
Germany | |
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten | |
Münster, Germany, 48179 | |
United Kingdom | |
Monklands Hospital, Department of Dermatology | |
Airdrie, United Kingdom, ML6 6JS |
Principal Investigator: | T A Luger, Dr. med. | Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten |
Study ID Numbers: | MBL 0407 INT |
Study First Received: | September 15, 2005 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00216879 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Calcipotriene Betamethasone-17,21-dipropionate Sodium phosphate Skin Diseases |
Psoriasis Betamethasone sodium phosphate Betamethasone Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Dermatologic Agents Hormones Glucocorticoids Pharmacologic Actions |