Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Novartis

Status and phase

Completed

Phase 3

Conditions

Tinea Capitis

Treatments

Drug: Griseofulvin

Drug: Terbinafine hydrochloride (HCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00117767

CSFO327C2301

Details and patient eligibility

About

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.

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
Male or female patients who are at least 4 years old and no more than 12 years old.

Exclusion criteria

Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
Patients receiving medication that may interfere with the evaluation of the drug's effect
Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments [e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products] within 1 week of screening).
Patients with a history of systemic lupus erythematosus