RANDOMIZED STUDY, WITH MASKED RESEARCHER, WITH ACTIVE CONTROL, OF PARALLEL GROUPS, TO COMPARE THE EFFICACY AND SAFETY OF THE TREATMENT OF 6 WEEKS WITH THE NEW PEDIATRIC FORMULATION OF TERBINAFIN VERSUS THE TREATMENT OF 6 WEEKS WITH THE PEDIATRIC SUSPENSION OF GRISEOFULVINE IN CHILDREN WITH TINEA CAPITIS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2004年9月29日最近更新: 2023年9月4日

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•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.

•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

发起方

OVARTIS BIOSCIENSES PERU S.A.,