Official Title: “An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: fluconazole
  • Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm A

Primary Measures

• Combined clinical and mycological outcome at Week 6
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10
  • Time Frame: Weeks 3, 6, and 10
    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
    Safety Issue?: No
• Culture results at Weeks 3, 6, and 10
  • Time Frame: Weeks 3, 6, and 10
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645242

Study ID Number: A0561017

ClinicalTrials.gov Identifier: NCT00645242

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.