Tinea Capitis
Conditions
Keywords
Terbinafine, Tinea capitis, pediatric, antifungal
Brief summary
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cure (negative mycology and clinical cure) rate at Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure rate at Week 10 | — |
| Mycological cure rate at Week 10 | — |
| Safety of terbinafine | — |
Countries
United States
Outcome results
None listed