A Study Of Diflucan In Children With Ringworm Of The Scalp

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00645242

Enrollment

185

Registered

2008-03-27

Start date

2002-11-30

Completion date

2003-03-31

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Capitis

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.

Interventions

DRUGfluconazole

Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Combined clinical and mycological outcome at Week 6	Week 6

Secondary

Measure	Time frame
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

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026