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| Sponsor: | LEO Pharma |
|---|---|
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00279162 |
Purpose
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 |
|---|---|---|
|
Psoriasis |
Drug: Calcipotriene/betamethasone gel and ointment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
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
More Information
| ClinicalTrials.gov Identifier: | NCT00279162 History of Changes |
| Other Study ID Numbers: | MBL 0502 US |
| Study First Received: | January 17, 2006 |
| Last Updated: | August 2, 2007 |
| Health Authority: | United States: Food and Drug Administration |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Calcipotriene Calcitriol Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Dermatologic Agents Vitamins Micronutrients Growth Substances Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents |