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OpenTrials
Completed

NCT Number: NCT00645242

A Study Of Diflucan In Children With Ringworm Of The Scalp

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.

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Key information

Conditions

Tinea Capitis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Scalp Dermatoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Carolina, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluconazole

Drug

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

Primary outcomes

  1. Combined clinical and mycological outcome at Week 6

    Time frame: Week 6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Mar 27, 2008
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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