A Study Of Diflucan In Children With Ringworm Of The Scalp - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645242

Purpose

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.

Condition	Intervention	Phase
Tinea Capitis	Drug: fluconazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis

Resource links provided by NLM:

MedlinePlus related topics: Tinea Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Combined clinical and mycological outcome at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ] [ Designated as safety issue: No ]
Combined clinical and mycological outcome at Weeks 3 and 10 [ Time Frame: Weeks 3 and 10 ]
Mycological outcome based on culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ] [ Designated as safety issue: No ]
Culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]

Estimated Enrollment:	185
Study Start Date:	November 2002
Study Completion Date:	March 2003

Arms	Assigned Interventions
Arm A: Experimental	Drug: fluconazole Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Eligibility

Ages Eligible for Study:	3 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645242

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Locations

United States, Alabama
Pfizer Investigational Site
MONTGOMERY, Alabama, United States, 36116
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
SAN DIEGO, California, United States, 92123
United States, Florida
Pfizer Investigational Site
MIAMI, Florida, United States, 33156
Pfizer Investigational Site
MIAMI, Florida, United States, 33156-7712
United States, Georgia
Pfizer Investigational Site
MARTINEZ, Georgia, United States, 30907
United States, Illinois
Pfizer Investigational Site
CHICAGO, Illinois, United States, 60630
Pfizer Investigational Site
Evanston, Illinois, United States, 60202
United States, Louisiana
Pfizer Investigational Site
SHREVEPORT, Louisiana, United States, 71105
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70119
Pfizer Investigational Site
Gretna, Louisiana, United States, 70056
United States, Michigan
Pfizer Investigational Site
DETROIT, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
FRIDLEY, Minnesota, United States, 55432
United States, Missouri
Pfizer Investigational Site
BRIDGETON, Missouri, United States, 63044
United States, New York
Pfizer Investigational Site
BROOKLYN, New York, United States, 11203-2098
United States, North Carolina
Pfizer Investigational Site
GARNER, North Carolina, United States, 27529
Pfizer Investigational Site
RALEIGH, North Carolina, United States, 27609
United States, Ohio
Pfizer Investigational Site
COLUMBUS, Ohio, United States, 43205
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, South Carolina
Pfizer Investigational Site
MOUNT PLEASANT, South Carolina, United States, 29464
Pfizer Investigational Site
MT. PLEASANT, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
MURFREESBORO, Tennessee, United States, 37130
Pfizer Investigational Site
KNOXVILLE, Tennessee, United States, 37927
Pfizer Investigational Site
Nashville, Tennessee, United States, 37215
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78224
Pfizer Investigational Site
Houston, Texas, United States, 77056
Pfizer Investigational Site
SAN ANTONIO, Texas, United States, 78205
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
NORFOLK, Virginia, United States, 23507
Puerto Rico
Pfizer Investigational Site
PONCE, Puerto Rico, 99717
Pfizer Investigational Site
Ponce, Puerto Rico, 00717-2115
Pfizer Investigational Site
Carolina, Puerto Rico, 00985

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0561017
Study First Received:	March 25, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00645242 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Skin Diseases
Infection
Pharmacologic Actions
Mycoses
Skin Diseases, Infectious

Antifungal Agents
Therapeutic Uses
Tinea Capitis
Scalp Dermatoses
Tinea
Dermatomycoses

ClinicalTrials.gov processed this record on November 27, 2009