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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00117754 |
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 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group 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: | July 2004 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SFO327C2302 |
Study First Received: | June 30, 2005 |
Last Updated: | February 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00117754 |
Health Authority: | United States: Food and Drug Administration; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; India: Institutional Review Board; Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council |
Terbinafine, Tinea capitis, pediatric, antifungal |
Mycoses Skin Diseases, Infectious Skin Diseases Clotrimazole Miconazole Tinea Capitis |
Tioconazole Griseofulvin Tinea Terbinafine Dermatomycoses |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents Antibiotics, Antifungal |
Enzyme Inhibitors Scalp Dermatoses Infection Pharmacologic Actions |