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A Study Of Diflucan In Children With Ringworm Of The Scalp

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645242
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 [ Time Frame: Weeks 3, 6, and 10 ]
  • 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 ]
  • 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645242


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645242     History of Changes
Other Study ID Numbers: A0561017
First Submitted: March 25, 2008
First Posted: March 27, 2008
Last Update Posted: March 27, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Tinea
Tinea Capitis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Scalp Dermatoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors