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Study of Topical Calcitriol in Children With Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
calcitriol
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring dermatologic disorders, psoriasis, rare disease

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2 --Prior/Concurrent Therapy-- No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels --Patient Characteristics-- Renal: No high blood or urinary calcium levels Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Boston University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006275
    Brief Title
    Study of Topical Calcitriol in Children With Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2000 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    Boston University

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.
    Detailed Description
    PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily. Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    dermatologic disorders, psoriasis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    calcitriol

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2 --Prior/Concurrent Therapy-- No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels --Patient Characteristics-- Renal: No high blood or urinary calcium levels Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael F. Holick
    Organizational Affiliation
    Boston University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of Topical Calcitriol in Children With Psoriasis

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