Official Title: “Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis”

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

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

Intervention(s) in this Clinical Trial

• Drug: Terbinafine hydrochloride (HCl)
  • Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
• Drug: Griseofulvin
  • Griseofulvin pediatric suspension o.d. administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Terbinafine
• Active Comparator: 2
  • Griseofulvin

Primary Measures

• Complete cure (negative mycology and clinical cure) rate at Week 10

Secondary Measures

• Clinical cure rate at Week 10
• Mycological cure rate at Week 10
• Safety of terbinafine

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117767

Study ID Number: CSFO327C2301

ClinicalTrials.gov Identifier: NCT00117767

Health Authority: United States: Food and Drug Administration

Novartis Patient recruitment website