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NCT00006275 Clinical Trial

Study of Topical Calcitriol in Children With Psoriasis

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006275
Other study ID # 199/15372
Secondary ID BUSM-90-106
Status Completed
Phase N/A
First received September 11, 2000
Last updated June 23, 2005
Start date July 2000
Est. completion date July 2000

Study information
Verified date September 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date July 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• calcitriol

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Boston University
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