Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Condition(s) targeted: Tinea Capitis

Intervention: Terbinafine hydrochloride (HCl) (Drug); Griseofulvin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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.

Official title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Complete cure (negative mycology and clinical cure) rate at Week 10

Secondary outcome:

Clinical cure rate at Week 10

Mycological cure rate at Week 10

Safety of terbinafine

Minimum age: 4 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Novartis Patient recruitment website

Starting date: June 2004
Ending date: March 2006
Last updated: January 4, 2008