A Study Of Diflucan In Children With Ringworm Of The Scalp

Condition(s) targeted: Tinea Capitis

Intervention: fluconazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

Primary outcome: Combined clinical and mycological outcome at Week 6

Secondary outcome:

Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10

Combined clinical and mycological outcome at Weeks 3 and 10

Mycological outcome based on culture results at Weeks 3, 6, and 10

Culture results at Weeks 3, 6, and 10

Minimum age: 3 Years. Maximum age: 12 Years. Gender(s): Both.

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

Pfizer Investigational Site, PONCE 99717, Puerto Rico

Pfizer Investigational Site, Ponce 00717-2115, Puerto Rico

Pfizer Investigational Site, Carolina 00985, Puerto Rico

Pfizer Investigational Site, MONTGOMERY, Alabama 36116, United States

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States

Pfizer Investigational Site, SAN DIEGO, California 92123, United States

Pfizer Investigational Site, MIAMI, Florida 33156, United States

Pfizer Investigational Site, MIAMI, Florida 33156-7712, United States

Pfizer Investigational Site, MARTINEZ, Georgia 30907, United States

Pfizer Investigational Site, CHICAGO, Illinois 60630, United States

Pfizer Investigational Site, Evanston, Illinois 60202, United States

Pfizer Investigational Site, SHREVEPORT, Louisiana 71105, United States

Pfizer Investigational Site, New Orleans, Louisiana 70119, United States

Pfizer Investigational Site, Gretna, Louisiana 70056, United States

Pfizer Investigational Site, DETROIT, Michigan 48201, United States

Pfizer Investigational Site, FRIDLEY, Minnesota 55432, United States

Pfizer Investigational Site, BRIDGETON, Missouri 63044, United States

Pfizer Investigational Site, BROOKLYN, New York 11203-2098, United States

Pfizer Investigational Site, GARNER, North Carolina 27529, United States

Pfizer Investigational Site, RALEIGH, North Carolina 27609, United States

Pfizer Investigational Site, COLUMBUS, Ohio 43205, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, MOUNT PLEASANT, South Carolina 29464, United States

Pfizer Investigational Site, MT. PLEASANT, South Carolina 29464, United States

Pfizer Investigational Site, MURFREESBORO, Tennessee 37130, United States

Pfizer Investigational Site, KNOXVILLE, Tennessee 37927, United States

Pfizer Investigational Site, Nashville, Tennessee 37215, United States

Pfizer Investigational Site, San Antonio, Texas 78224, United States

Pfizer Investigational Site, Houston, Texas 77056, United States

Pfizer Investigational Site, SAN ANTONIO, Texas 78205, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, NORFOLK, Virginia 23507, United States

To obtain contact information for a study center near you, click here.

Starting date: November 2002
Ending date: March 2003
Last updated: March 25, 2008