None listed
Conditions
Interventions
Terbinafine Type of group
Terbinafine is administered once a day for 6 weeks
Group name:Griseofulvin Type of group
Griseofulvin is administered once a day for 6 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion 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
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 |
|---|---|
| Outcome name:Complete cure Measure:Complete cure (negative mycology and clinical cure) rate at Week 10 Timepoints:Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical cure rate Measure:Clinical cure rate at Week 10 Timepoints:Week 10 | — |
Countries
Peru, United States
Outcome results
None listed