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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00645242 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Multicenter Trial Of Diflucan (Fluconazole) For 6 Weeks Given Once Daily To Pediatric Patients With Tinea Capitis |
Estimated Enrollment: | 185 |
Study Start Date: | November 2002 |
Study Completion Date: | March 2003 |
Arms | Assigned Interventions |
---|---|
Arm A: Experimental |
Drug: fluconazole
Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment
|
Ages Eligible for Study: | 3 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0561017 |
Study First Received: | March 25, 2008 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00645242 |
Health Authority: | United States: Food and Drug Administration |
Fluconazole Mycoses Skin Diseases, Infectious Skin Diseases Clotrimazole |
Miconazole Tinea Capitis Tioconazole Tinea Dermatomycoses |
Anti-Infective Agents Therapeutic Uses Antifungal Agents |
Scalp Dermatoses Infection Pharmacologic Actions |