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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
720
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
Griseofulvin pediatric suspension o.d. administration
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Complete cure (negative mycology and clinical cure) rate at Week 10
Clinical cure rate at Week 10
Mycological cure rate at Week 10
Safety of terbinafine
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