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A Study Of Diflucan In Children With Ringworm Of The Scalp

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645242
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Tinea Capitis
Drug: fluconazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Combined clinical and mycological outcome at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 185
Study Start Date: November 2002
Study Completion Date: March 2003
Arms Assigned Interventions
Experimental: Arm A Drug: fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645242

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645242     History of Changes
Other Study ID Numbers: A0561017
Study First Received: March 25, 2008
Last Updated: March 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinea Capitis
Dermatomycoses
Infection
Mycoses
Scalp Dermatoses
Skin Diseases
Skin Diseases, Infectious
Tinea
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014