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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419666
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: Calcitriol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Calcitriol

Arm Intervention/treatment
Experimental: Calcitriol Drug: Calcitriol

Primary Outcome Measures :
  1. PK [ Time Frame: 0, 1, 3, 4, 6, 9 ]

Secondary Outcome Measures :
  1. PD [ Time Frame: 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419666

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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
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1B 3E1
Newlab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Sponsors and Collaborators
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Study Director: Michael Graeber, MD Galderma

Additional Information:
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Responsible Party: Galderma Identifier: NCT00419666     History of Changes
Other Study ID Numbers: RD.06.SPR.18102
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: April 2011
Keywords provided by Galderma:
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents