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| Sponsor: | LEO Pharma |
|---|---|
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00704262 |
Purpose
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Vulgaris |
Drug: Calcipotriol plus hydrocortisone (LEO 80190) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Calcipotriol Plus Hydrocortisone Ointment on the HPA Axis and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and on the Intertriginous Areas |
| Enrollment: | 33 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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| United States, Arkansas | |
| Burke Pharmaceuticals | |
| Hot Springs, Arkansas, United States, 71913 | |
| Dermatology Research of Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Florida | |
| Ameriderm Research | |
| Ormond Beach, Florida, United States, 32174 | |
| United States, Michigan | |
| Somerset Skin Center | |
| Troy, Michigan, United States, 48084 | |
| United States, New Jersey | |
| Psoriasis Treatment Center of Central NJ | |
| East Windsor, New Jersey, United States, 08520 | |
| United States, Virginia | |
| Virginia Clinical Research, Inc. | |
| Norfolk, Virginia, United States, 23507 | |
| Canada, Ontario | |
| The Guenther Dermatology Research Centre | |
| London, Ontario, Canada, N6A3H7 | |
| Germany | |
| Institute of Clinical Pharmacology Parexel International Gmbh | |
| Berlin, Germany, 12351 | |
| United Kingdom | |
| The Dermatology Centre, Hope Hospital | |
| Manchester, United Kingdom, M6 8HD | |
| ICON Development Solutions | |
| Manchester, United Kingdom, M15 6SH | |
| United Kingdom, Cambridge | |
| LCG Bioscience | |
| Bourn, Cambridge, United Kingdom, CB3 7TR | |
| Principal Investigator: | Rainard Fuhr, MD, PhD | Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany |
More Information
| Responsible Party: | LEO Pharma A/S ( Maj Britt Larsen, International Clinical Trial Manager ) |
| Study ID Numbers: | LEO 80190-O23 |
| Study First Received: | June 23, 2008 |
| Last Updated: | December 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00704262 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Canada: Health Canada |
|
Anti-Inflammatory Agents Calcipotriene Hydrocortisone Cortisol succinate Skin Diseases Psoriasis |
Therapeutic Uses Hydrocortisone acetate Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions |