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| Sponsor: | LEO Pharma |
|---|---|
| Information provided by: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT00691002 |
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 compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis Vulgaris |
Drug: Calcipotriol plus hydrocortisone (LEO 80190) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas |
| Enrollment: | 1245 |
| Study Start Date: | May 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (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| Croatia | |
| Croatia - managed by CRO | |
| Zagreb, Croatia, 10000 | |
| Macedonia - managed by CRO | |
| Zagreb, Croatia, 10000 | |
| Slovenia - managed by CRO | |
| Zagreb, Croatia, 10000 | |
| Germany | |
| Department of Dermatology and Allergy, University of Bonn | |
| Bonn, Germany, 53105 | |
| Poland | |
| Czech Republic - managed by CRO | |
| Warszawa, Poland, 02-019 | |
| Hungary - managed by CRO | |
| Warszawa, Poland, 02-019 | |
| Latvia - managed by CRO | |
| Warszawa, Poland, 02-019 | |
| Poland - managed by CRO | |
| Warszawa, Poland, 02-019 | |
| The Netherlands - managed by CRO | |
| Warszawa, Poland | |
| Belgium - managed by CRO | |
| Warszawa, Poland | |
| Serbia | |
| Serbia - managed by CRO | |
| New Belgrade, Serbia, 11070 | |
| Principal Investigator: | Thomas Bieber, MD | Department of Dermatology and Allergy, University of Bonn |
More Information
| Responsible Party: | LEO Pharma A/S ( Lotte V. Tingleff/Principal Clinical Trial Manager ) |
| Study ID Numbers: | LEO 80190-O21 |
| Study First Received: | June 3, 2008 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00691002 History of Changes |
| Health Authority: | Czech Republic: State Institute for Drug Control; Croatia: Ministry of Health and Social Care; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Macedonia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovenia: Agency for Medicinal Products - Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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Anti-Inflammatory Agents Calcipotriene Hydrocortisone Cortisol succinate Skin Diseases Psoriasis |
Therapeutic Uses Hydrocortisone acetate Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions |