Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Completed
Novartis
Phase 3
2004-07-01
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.
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Completed
Novartis Pharmaceuticals
Phase 3
2004-06-01
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.
The purpose of this study is to compare, in a controlled fashion, the response to two
anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations
in the treatment of subjects with distal subungual tinea unguium of the toenails
(onychomycosis).
The formulation used as the vehicle for the active agents has been shown in earlier studies
to facilitate the penetration of the active agent through fungally-infected nails. This study
will examine dose-response and agent differences in terms of efficacy and safety.
Once the subject has qualified for the study, he/she will be randomly assigned to one of five
study groups, dispensed appropriate study medication and instructed to apply one drop to the
great toe designated for study.
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