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

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

MedlinePlus related topics:

Tinea Infections

ChemIDplus related topics:

Fluconazole

U.S. FDA Resources

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

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

Show 32 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

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

Study placed in the following topic categories:

Fluconazole

Mycoses

Skin Diseases, Infectious

Skin Diseases

Clotrimazole

Miconazole

Tinea Capitis

Tioconazole

Tinea

Dermatomycoses

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Scalp Dermatoses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

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