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A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00419666
First received: January 5, 2007
Last updated: March 8, 2012
Last verified: April 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • PK [ Time Frame: 0, 1, 3, 4, 6, 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PD [ Time Frame: 0 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: August 2006
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcitriol Drug: Calcitriol
BID

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic plaque psoriasis
  • 10 - 35% BSA of involved skin
  • Age 12 - 17

Exclusion Criteria:

  • Other type of psoriasis (other than plaque)
  • Significant abnormal lab findings
  • Vit D insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419666

Locations
United States, Arkansas
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital, Department of Pediatric and Adolescent Dermatology
San Diego, California, United States, 92123
United States, Minnesota
Dermatology Center For Children & Young Adults
Eagan, Minnesota, United States, 55121
United States, Texas
University of Texas-Houston Medical Center Dept of Dermatology
Houston, Texas, United States, 77030
Center for Clinical Studies
Webster, Texas, United States, 77598
Canada, Newfoundland and Labrador
Newlab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

Additional Information:
No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00419666     History of Changes
Other Study ID Numbers: RD.06.SPR.18102
Study First Received: January 5, 2007
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Calcitriol
Psoriasis
PK
Adolescents

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014