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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00279162 |
Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks.
The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
Condition | Intervention | Phase |
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Psoriasis |
Drug: Calcipotriene/betamethasone gel and ointment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Calcipotriene Plus Betamethasone Dipropionate Gel Compared to the Gel Vehicle in Scalp Psoriasis, in Patients Receiving Calcipotriene Plus Betamethasone Dipropionate Ointment for Psoriasis Vulgaris of Trunk/Limbs |
Estimated Enrollment: | 160 |
Study Start Date: | December 2005 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | MBL 0502 US |
Study First Received: | January 17, 2006 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00279162 |
Health Authority: | United States: Food and Drug Administration |
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 |