A Study Of Diflucan In Children With Ringworm Of The Scalp

NCT ID: NCT00645242

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tinea Capitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Group Type EXPERIMENTAL

fluconazole

Intervention Type DRUG

Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluconazole

Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Montgomery, Alabama, United States

Site Status

Pfizer Investigational Site

Little Rock, Arkansas, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Martinez, Georgia, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Evanston, Illinois, United States

Site Status

Pfizer Investigational Site

Gretna, Louisiana, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

Fridley, Minnesota, United States

Site Status

Pfizer Investigational Site

Bridgeton, Missouri, United States

Site Status

Pfizer Investigational Site

Brooklyn, New York, United States

Site Status

Pfizer Investigational Site

Garner, North Carolina, United States

Site Status

Pfizer Investigational Site

Raleigh, North Carolina, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

Pfizer Investigational Site

Knoxville, Tennessee, United States

Site Status

Pfizer Investigational Site

Murfreesboro, Tennessee, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Norfolk, Virginia, United States

Site Status

Pfizer Investigational Site

Carolina, , Puerto Rico

Site Status

Pfizer Investigational Site

Ponce, , Puerto Rico

Site Status

Pfizer Investigational Site

Ponce, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0561017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.