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A Study Of Diflucan In Children With Ringworm Of The Scalp

This study has been completed.
Study NCT00645242.   Last updated on March 25, 2008.   Information provided by Pfizer

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Descriptive Information Fields
Brief Title  A Study Of Diflucan In Children With Ringworm Of The Scalp
Official Title  An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With 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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Combined clinical and mycological outcome at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Culture results at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]
Condition  Tinea Capitis
Intervention  Drug: fluconazole
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Completed
Enrollment  185
Start Date  November 2002
Completion Date March 2003
Eligibility Criteria 

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 Both
Ages 3 Years to 12 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00645242
Organization ID A0561017
Secondary IDs ††
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Study Director:     Pfizer CT.gov Call Center     Pfizer    
Information Provided By Pfizer
Verification Date March 2008
First Received Date  March 25, 2008
Last Updated Date March 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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