A Study Of Diflucan In Children With Ringworm Of The Scalp

Phase 3

Completed

• Conditions: Tinea Capitis
• Interventions: Drug: fluconazole

• Registration Number: NCT00645242
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	fluconazole	-

Primary Outcome Measures

Name	Time	Method
Combined clinical and mycological outcome at Week 6	Week 6

Secondary Outcome Measures

Name	Time	Method
Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10	Weeks 3, 6, and 10
Combined clinical and mycological outcome at Weeks 3 and 10	Weeks 3 and 10
Mycological outcome based on culture results at Weeks 3, 6, and 10	Weeks 3, 6, and 10
Culture results at Weeks 3, 6, and 10	Weeks 3, 6, and 10

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Ponce, Puerto Rico