A Study Of Diflucan In Children With Ringworm Of The Scalp

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645242
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
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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.

Condition or disease Intervention/treatment Phase
Tinea Capitis Drug: fluconazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections
Drug Information available for: Fluconazole
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Combined clinical and mycological outcome at Week 6 [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]
  2. Combined clinical and mycological outcome at Weeks 3 and 10 [ Time Frame: Weeks 3 and 10 ]
  3. Mycological outcome based on culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]
  4. Culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645242

  Show 32 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00645242     History of Changes
Other Study ID Numbers: A0561017
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Tinea Capitis
Skin Diseases, Infectious
Skin Diseases
Scalp Dermatoses
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors