A Study Of Diflucan In Children With Ringworm Of The Scalp

NCT00645242

Last updated date
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36116, United States
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tinea Capitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Negative baseline KOH


- Liver disease

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Tinea CapitisA Study Of Diflucan In Children With Ringworm Of The Scalp
NCT00645242
  1. Montgomery, Alabama
  2. Little Rock, Arkansas
  3. San Diego, California
  4. Miami, Florida
  5. Miami, Florida
  6. Martinez, Georgia
  7. Chicago, Illinois
  8. Evanston, Illinois
  9. Gretna, Louisiana
  10. New Orleans, Louisiana
  11. Shreveport, Louisiana
  12. Detroit, Michigan
  13. Fridley, Minnesota
  14. Bridgeton, Missouri
  15. Brooklyn, New York
  16. Garner, North Carolina
  17. Raleigh, North Carolina
  18. Cleveland, Ohio
  19. Columbus, Ohio
  20. Mount Pleasant, South Carolina
  21. Mt. Pleasant, South Carolina
  22. Knoxville, Tennessee
  23. Murfreesboro, Tennessee
  24. Nashville, Tennessee
  25. Houston, Texas
  26. San Antonio, Texas
  27. San Antonio, Texas
  28. San Antonio, Texas
  29. Norfolk, Virginia
  30. Carolina,
  31. Ponce,
  32. Ponce,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Diflucan In Children With Ringworm Of The Scalp
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinea Capitis
Intervention  ICMJE Drug: fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
Study Arms  ICMJE Experimental: Arm A
Intervention: Drug: fluconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 25, 2008)
185
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645242
Other Study ID Numbers  ICMJE A0561017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP