Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Not Applicable

• Conditions: -B350 Tinea barbae and tinea capitis; Tinea barbae and tinea capitis; B350

• Registration Number: PER-038-04
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified