Clinical trial NCT00645242: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Capitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 185
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Combined clinical and mycological outcome at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10
timeFrame: Weeks 3, 6, and 10
measure: Combined clinical and mycological outcome at Weeks 3 and 10
timeFrame: Weeks 3 and 10
measure: Mycological outcome based on culture results at Weeks 3, 6, and 10
timeFrame: Weeks 3, 6, and 10
measure: Culture results at Weeks 3, 6, and 10
timeFrame: Weeks 3, 6, and 10
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Martinez
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Gretna
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Bridgeton
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Garner
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Carolina
country: Puerto Rico
facility: Pfizer Investigational Site
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: