|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 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: Maj Britt Larsen, Phd | 45-4494-5888 | maj.larsen@leo-pharma.com |
| Contact: Vibeke Hoffmann, MSc Pharm | 45-4494-5888 | vibeke.hoffmann@leo-pharma.com |
| United States, Arkansas | |
| Burke Pharmaceuticals | Recruiting |
| Hot Springs, Arkansas, United States, 71913 | |
| Contact: Tim Dugan 501-620-4449 tdugan@burkepharmaceutical.com | |
| Contact: Laura Manley 501 620 4449 lmanley@burkepharmaceutical.com | |
| Principal Investigator: Dow Stough, MD | |
| Dermatology Research of Arkansas | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Brittany Kiele 501-227-8422 ext 35 brittanykiele01@yahoo.com | |
| Contact: Betty Davis 501-227-8422 ext 21 Bettydavis01@sbcglobal.net | |
| Principal Investigator: Scott Dinehart, MD | |
| United States, Florida | |
| Ameriderm Research | Recruiting |
| Ormond Beach, Florida, United States, 32174 | |
| Contact: Kathy Evans, RN 386-898-0547 ext 116 Kevans@Leavittmgt.com | |
| Contact: Yvonne Douglas 386-898-0547 ext 110 Ydouglas@Leavittmgt.com | |
| Principal Investigator: James A. Solomon, MD | |
| United States, Michigan | |
| Somerset Skin Center | Recruiting |
| Troy, Michigan, United States, 48084 | |
| Contact: Dianna Fortunato 248-244-8448 Dianna@somersetskincentre.com | |
| Contact: Heather Minard 248-244-8448 Heather@somersetskincentre.com | |
| Principal Investigator: George Murakawa, MD | |
| United States, New Jersey | |
| Psoriasis Treatment Center of Central NJ | Recruiting |
| East Windsor, New Jersey, United States, 08520 | |
| Contact: Elise Nelson 609-443-4501 ext 36 elisepsoriasis@aol.com | |
| Contact: Sandy Sanderstokes 609-443-4501 ext 29 sandypsoriasis@aol.com | |
| Principal Investigator: Jerry Bagel, MD | |
| United States, Virginia | |
| Virginia Clinical Research, Inc. | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: JoEllen Wyer 757-625-0151 ext 52 jwyer@vcrinc.org | |
| Contact: Rebecca Heroux 757-625-0151 ext 13 bheroux@vcrinc.org | |
| Principal Investigator: David Pariser, MD | |
| Canada, Ontario | |
| The Guenther Dermatology Research Centre | Recruiting |
| London, Ontario, Canada, N6A3H7 | |
| Contact: Lyn Guenther, MD +1 519 435 1738 dgue@gdrc.ca | |
| Principal Investigator: Lyn Guenther, MD | |
| Germany | |
| Institute of Clinical Pharmacology Parexel International Gmbh | Recruiting |
| Berlin, Germany, 12351 | |
| Contact: Rainard Fuhr, MD, PhD 49-3030-685-414 rainard.fuhr@parexel.com | |
| Principal Investigator: Rainard Fuhr, MD, PhD | |
| United Kingdom | |
| The Dermatology Centre, Hope Hospital | Recruiting |
| Manchester, United Kingdom, M6 8HD | |
| Contact: Christopher Griffiths, Professor 44-0161-206-4392 | |
| ICON Development Solutions | Recruiting |
| Manchester, United Kingdom, M15 6SH | |
| Contact: Simon Constable, MD +44 (161) 232 2715 simon.constable@iconplc.com | |
| Principal Investigator: Simon Constable, MD | |
| United Kingdom, Cambridge | |
| LCG Bioscience | Recruiting |
| Bourn, Cambridge, United Kingdom, CB3 7TR | |
| Contact: Anthony Priestley, MD +44 (0)1954 717535 | |
| Principal Investigator: Anthony Priestley, MD | |
| 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: | August 13, 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 |