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...
Date First Received: March 25, 2008
Last Updated: March 25, 2008
Verified by: Pfizer, March 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 185
Brief Summary
Official Title: “An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis”
Condition Keyword(s):
Intervention(s):
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
Outcome Measures for this Clinical Trial
Primary Measures
- Combined clinical and mycological outcome at Week 6
- Time Frame: Week 6
Safety Issue?: No
- Time Frame: Week 6
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
- Time Frame: Weeks 3, 6, and 10
- Combined clinical and mycological outcome at Weeks 3 and 10
- Time Frame: 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
- Time Frame: Weeks 3, 6, and 10
- Culture results at Weeks 3, 6, and 10
- Time Frame: Weeks 3, 6, and 10
- Time Frame: Weeks 3, 6, and 10
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
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
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