Study of Topical Calcitriol in Children With Psoriasis

NCT ID: NCT00006275

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2000-07-31

Brief Summary

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OBJECTIVES:

I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.

Detailed Description

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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.

Conditions

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Psoriasis

Keywords

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dermatologic disorders psoriasis rare disease

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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calcitriol

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Michael F. Holick

Role: STUDY_CHAIR

Boston University

Other Identifiers

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BUSM-90-106

Identifier Type: -

Identifier Source: secondary_id

199/15372

Identifier Type: -

Identifier Source: org_study_id