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A Study Of Diflucan In Children With Ringworm Of The Scalp

Primary Purpose

Tinea Capitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

fluconazole

About this trial

This is an interventional treatment trial for Tinea Capitis

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Outcomes

Primary Outcome Measures

Combined clinical and mycological outcome at Week 6

Secondary Outcome Measures

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

Combined clinical and mycological outcome at Weeks 3 and 10

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

Culture results at Weeks 3, 6, and 10

Full Information

NCT ID

NCT00645242

First Posted

March 25, 2008

Last Updated

July 15, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00645242

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Capitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

185 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

fluconazole

Intervention Description

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

Primary Outcome Measure Information:

Title

Combined clinical and mycological outcome at Week 6

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

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

Time Frame

Weeks 3, 6, and 10

Title

Combined clinical and mycological outcome at Weeks 3 and 10

Time Frame

Weeks 3 and 10

Title

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

Time Frame

Weeks 3, 6, and 10

Title

Culture results at Weeks 3, 6, and 10

Time Frame

Weeks 3, 6, and 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36116

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156-7712

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Pfizer Investigational Site

City

Martinez

State/Province

Georgia

ZIP/Postal Code

30907

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60630

Country

United States

Facility Name

Pfizer Investigational Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60202

Country

United States

Facility Name

Pfizer Investigational Site

City

Gretna

State/Province

Louisiana

ZIP/Postal Code

70056

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Pfizer Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Pfizer Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Pfizer Investigational Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Pfizer Investigational Site

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203-2098

Country

United States

Facility Name

Pfizer Investigational Site

City

Garner

State/Province

North Carolina

ZIP/Postal Code

27529

Country

United States

Facility Name

Pfizer Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

Pfizer Investigational Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Pfizer Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37927

Country

United States

Facility Name

Pfizer Investigational Site

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77056

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78224

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Pfizer Investigational Site

City

Carolina

ZIP/Postal Code

00985

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Ponce

ZIP/Postal Code

00717-2115

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Ponce

ZIP/Postal Code

99717

Country

Puerto Rico

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0561017&StudyName=A%20Study%20Of%20Diflucan%20In%20Children%20With%20Ringworm%20Of%20The%20Scalp

Description

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A Study Of Diflucan In Children With Ringworm Of The Scalp

Tinea Capitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial