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| Sponsored by: |
Galderma |
|---|---|
| Information provided by: | Galderma |
| ClinicalTrials.gov Identifier: | NCT00419666 |
Purpose
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Plaque Psoriasis |
Drug: Calcitriol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joyce Hwa, RN | 609-860-8235 | joyce.hwa@galderma.com |
| United States, Arkansas | |
| Dermatology Research of Arkansas | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Daniel Smith, MD 501-227-8422 | |
| Principal Investigator: Daniel Smith, MD | |
| United States, California | |
| Children's Hospital, Department of Pediatric and Adolescent Dermatology | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Lawrence F Eichenfield, MD | |
| Contact: Nicola Borok, RN 858-576-1700 ext 4295 | |
| Principal Investigator: Lawrence F Eichenfield, MD | |
| United States, Minnesota | |
| Dermatology Center For Children & Young Adults | Recruiting |
| Eagan, Minnesota, United States, 55121 | |
| Contact: Kenneth Bloom, MD 651-379-9999 | |
| Principal Investigator: Kenneth Bloom, MD | |
| United States, Texas | |
| University of Texas-Houston Medical Center Dept of Dermatology | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Adelaide Hebert, MD 713-500-8266 | |
| Principal Investigator: Adelaide Hebert, MD | |
| Center for Clinical Studies | Recruiting |
| Webster, Texas, United States, 77598 | |
| Contact: Stephen K. Tyring, MD 281-333-2288 | |
| Principal Investigator: Stephen K. Tyring, MD | |
| Canada, Newfoundland and Labrador | |
| Newlab Clinical Research, Inc. | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1C 2H5 | |
| Contact: Wayne Gulliver, MD 709-753-5522 ext 207 | |
| Principal Investigator: Wayne Gulliver, MD | |
| Nexus Clinical Research | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3E1 | |
| Contact: Ian Landells, MD 709-726-3386 | |
| Principal Investigator: Ian Landells, MD | |
| Study Director: | Michael Graeber, MD | Galderma |
More Information
| Responsible Party: | Galderma ( Michael Graeber, MD ) |
| Study ID Numbers: | RD.06.SPR.18102 |
| Study First Received: | January 5, 2007 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00419666 |
| Health Authority: | United States: Food and Drug Administration |
|
Calcitriol Psoriasis PK Adolescents |
|
Calcium, Dietary Skin Diseases Psoriasis Skin Diseases, Papulosquamous Calcitriol |
|
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Growth Substances Vitamins Calcium Channel Agonists |
Physiological Effects of Drugs Vasoconstrictor Agents Bone Density Conservation Agents Cardiovascular Agents Micronutrients Pharmacologic Actions |
