A Study Of Diflucan In Children With Ringworm Of The Scalp

July 15, 2021 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

185

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Pfizer Investigational Site
      • Ponce, Puerto Rico, 00717-2115
        • Pfizer Investigational Site
      • Ponce, Puerto Rico, 99717
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33156-7712
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33156
        • Pfizer Investigational Site
    • Georgia
      • Martinez, Georgia, United States, 30907
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60630
        • Pfizer Investigational Site
      • Evanston, Illinois, United States, 60202
        • Pfizer Investigational Site
    • Louisiana
      • Gretna, Louisiana, United States, 70056
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70119
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Pfizer Investigational Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203-2098
        • Pfizer Investigational Site
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43205
        • Pfizer Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37927
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37215
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77056
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78205
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78224
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Drug: fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined clinical and mycological outcome at Week 6
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10
Time Frame: Weeks 3, 6, and 10
Weeks 3, 6, and 10
Combined clinical and mycological outcome at Weeks 3 and 10
Time Frame: Weeks 3 and 10
Weeks 3 and 10
Mycological outcome based on culture results at Weeks 3, 6, and 10
Time Frame: Weeks 3, 6, and 10
Weeks 3, 6, and 10
Culture results at Weeks 3, 6, and 10
Time Frame: Weeks 3, 6, and 10
Weeks 3, 6, and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (ACTUAL)

March 1, 2003

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0561017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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