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

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

March 25, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study Of Diflucan In Children With Ringworm Of The Scalp

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Tinea Capitis

Intervention ^ICMJE

Drug: fluconazole

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

Estimated Enrollment ^ICMJE

185

Completion Date

March 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00645242

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0561017

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

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