NCT00645242

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3

Geographic Reach
2 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

First QC Date

March 25, 2008

Last Update Submit

July 15, 2021

Conditions

Tinea Capitis

Outcome Measures

Primary Outcomes (1)

  • Combined clinical and mycological outcome at Week 6

    Week 6

Secondary Outcomes (4)

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

    Weeks 3, 6, and 10

  • Combined clinical and mycological outcome at Weeks 3 and 10

    Weeks 3 and 10

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

    Weeks 3, 6, and 10

  • Culture results at Weeks 3, 6, and 10

    Weeks 3, 6, and 10

Study Arms (1)

Arm A

EXPERIMENTAL
Drug: fluconazole

Interventions

fluconazoleDRUG

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

Arm A

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients (aged 3-12 years)
  • Clinical diagnosis of tinea capitis
  • Direct microscopy (KOH) positive for fungal elements within or outside hair shaft

You may not qualify if:

  • Negative baseline KOH
  • Liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Pfizer Investigational Site

Montgomery, Alabama, 36116, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

Miami, Florida, 33156-7712, United States

Location

Pfizer Investigational Site

Miami, Florida, 33156, United States

Location

Pfizer Investigational Site

Martinez, Georgia, 30907, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60630, United States

Location

Pfizer Investigational Site

Evanston, Illinois, 60202, United States

Location

Pfizer Investigational Site

Gretna, Louisiana, 70056, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70119, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71105, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48201, United States

Location

Pfizer Investigational Site

Fridley, Minnesota, 55432, United States

Location

Pfizer Investigational Site

Bridgeton, Missouri, 63044, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11203-2098, United States

Location

Pfizer Investigational Site

Garner, North Carolina, 27529, United States

Location

Pfizer Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43205, United States

Location

Pfizer Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37927, United States

Location

Pfizer Investigational Site

Murfreesboro, Tennessee, 37130, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37215, United States

Location

Pfizer Investigational Site

Houston, Texas, 77056, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78205, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78224, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Norfolk, Virginia, 23507, United States

Location

Pfizer Investigational Site

Carolina, 00985, Puerto Rico

Location

Pfizer Investigational Site

Ponce, 00717-2115, Puerto Rico

Location

Pfizer Investigational Site

Ponce, 99717, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Tinea Capitis

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousScalp DermatosesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

November 1, 2002

Study Completion

March 1, 2003

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

US(28)PR(3)