A Study Of Diflucan In Children With Ringworm Of The Scalp - Tabular View

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A Study Of Diflucan In Children With Ringworm Of The Scalp

This study has been completed.

Study NCT00645242. Last updated on March 25, 2008. Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Study Of Diflucan In Children With Ringworm Of The Scalp

Official Title ^†

An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Combined clinical and mycological outcome at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ] [ Designated as safety issue: No ]
Combined clinical and mycological outcome at Weeks 3 and 10 [ Time Frame: Weeks 3 and 10 ]
Mycological outcome based on culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ] [ Designated as safety issue: No ]
Culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]

Condition ^†

Tinea Capitis

Intervention ^†

Drug: fluconazole

MEDLINE PMIDs

Links

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

185

Start Date ^†

November 2002

Completion Date

March 2003

Eligibility Criteria ^†

Inclusion Criteria:

Pediatric patients (aged 3-12 years)
Clinical diagnosis of tinea capitis
Direct microscopy (KOH) positive for fungal elements within or outside hair shaft

Exclusion Criteria:

Negative baseline KOH
Liver disease

Gender

Both

Ages

3 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Puerto Rico

Administrative Information Fields

NCT ID ^†

NCT00645242

Organization ID

A0561017

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

First Received Date ^†

March 25, 2008

Last Updated Date

March 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.