Study of Topical Calcitriol in Children With Psoriasis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

July 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Topical Calcitriol in Children With Psoriasis

Official Title ^ICMJE

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: calcitriol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00006275

Responsible Party

Study ID Numbers ^ICMJE

199/15372, BUSM-90-106

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Boston University

Investigators ^ICMJE

Study Chair:

Michael F. Holick

Boston University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

September 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP