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NCT00645242 Clinical Trial

A Study Of Diflucan In Children With Ringworm Of The Scalp

Tinea Capitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00645242
Other study ID # A0561017
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2002
Est. completion date March 2003

Study information
Verified date July 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 185
Est. completion date March 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Locations
Country Name City State
Puerto Rico Pfizer Investigational Site Carolina
Puerto Rico Pfizer Investigational Site Ponce
Puerto Rico Pfizer Investigational Site Ponce
United States Pfizer Investigational Site Bridgeton Missouri
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Evanston Illinois
United States Pfizer Investigational Site Fridley Minnesota
United States Pfizer Investigational Site Garner North Carolina
United States Pfizer Investigational Site Gretna Louisiana
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Martinez Georgia
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Murfreesboro Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined clinical and mycological outcome at Week 6 Week 6
Secondary Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 Weeks 3, 6, and 10
Secondary Combined clinical and mycological outcome at Weeks 3 and 10 Weeks 3 and 10
Secondary Mycological outcome based on culture results at Weeks 3, 6, and 10 Weeks 3, 6, and 10
Secondary Culture results at Weeks 3, 6, and 10 Weeks 3, 6, and 10
See also
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Completed NCT02725255 - Design and Clinical Evaluation of a School Meal With Deworming Properties Phase 2/Phase 3
Completed NCT02550496 - Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis N/A
Completed NCT00127868 - Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm) N/A
Completed NCT00117767 - Terbinafine Compared to Griseofulvin in Children With Tinea Capitis Phase 3
Completed NCT00117754 - Terbinafine Compared to Griseofulvin in Children With Tinea Capitis Phase 3
Withdrawn NCT02658292 - Safety and Efficacy of NAFT900 in Children With Tinea Capitis Phase 2

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