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.

Condition	Intervention	Phase
Tinea Capitis	Drug: Terbinafine hydrochloride	Phase III

Further Study Details: 

Ages Eligible for Study:  4 Years   -   12 Years,  Genders Eligible for Study:  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

Please refer to this study by ClinicalTrials.gov identifier  NCT00117767

Novartis Pharmaceuticals      862 778 8300 

New Jersey
      Novartis Pharmaceuticals, East Hanover,  New Jersey,  United States; Recruiting

Study ID Numbers:  SFO327C2301
Record last reviewed:  July 2005
Last Updated:  July 21, 2005
Record first received:  July 7, 2005
ClinicalTrials.gov Identifier:  NCT00117767
Health Authority: United States: Food and Drug Administration; Canada: Health Canada; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2005-07-26