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| Sponsored by: |
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 |
| MedlinePlus related topics: | Psoriasis |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | April 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| Contact: Vibeke Hoffmann, MSc Pharm | 45-4494-5888 | vibeke.hoffmann@leo-pharma.com |
| Contact: Maj Britt Larsen, Phd | 45-4494-5888 | maj.larsen@leo-pharma.com |
| Germany | |||||
| Parexel International Gmbh, Klinikum Neukölln, Klinik 2, Pavillon 12, Rudower Strasse 48 | Recruiting | ||||
| Berlin, Germany, 12351 | |||||
| Contact: Dago Mazur, MD, PhD 49-3030-685-4055 dago.mazur@parexel.com | |||||
| United Kingdom | |||||
| The Dermatology Centre, Hope Hospital | Not yet recruiting | ||||
| Manchester, United Kingdom, M6 8HD | |||||
| Contact: Christopher Griffiths, Professor 44-0161-206-4392 | |||||
| LEO Pharma |
| Principal Investigator: | Dago Mazur, MD, PhD | Parexel International GmbH, Klinikum Neukölln, Klinik 2, Pavillon 12, Rudower Strasse 48, 12531 Berlin, Germany |
More Information
| Responsible Party: | LEO Pharma A/S ( Vibeke Hoffmann, Principal Clinical Project Manager ) |
| Study ID Numbers: | LEO 80190-O23 |
| First Received: | June 23, 2008 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00704262 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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