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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00117767 |
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
Condition | Intervention | Phase |
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Tinea Capitis |
Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis |
Estimated Enrollment: | 720 |
Study Start Date: | June 2004 |
Study Completion Date: | March 2006 |
Arms | Assigned Interventions |
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1: Experimental
Terbinafine
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Drug: Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
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2: Active Comparator
Griseofulvin
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Drug: Griseofulvin
Griseofulvin pediatric suspension o.d. administration
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Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSFO327C2301 |
Study First Received: | June 30, 2005 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00117767 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; South Africa: Medicines Control Council |
Terbinafine, Tinea capitis, pediatric, antifungal |
Skin Diseases Clotrimazole Miconazole Tioconazole Mycoses Anti-Bacterial Agents Skin Diseases, Infectious |
Antifungal Agents Tinea Capitis Griseofulvin Tinea Dermatomycoses Terbinafine |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Enzyme Inhibitors Infection Pharmacologic Actions Mycoses Skin Diseases, Infectious Therapeutic Uses |
Antifungal Agents Tinea Capitis Antibiotics, Antifungal Griseofulvin Scalp Dermatoses Tinea Dermatomycoses Terbinafine |