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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: Arm A	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

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

Additional relevant MeSH terms:

Tinea
Tinea Capitis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Scalp Dermatoses

Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012