Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Conditions
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Tinea Capitis

Intervention / Treatment
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* Drug: Terbinafine hydrochloride (HCl)
* Drug: Griseofulvin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Terbinafine | Drug: Terbinafine hydrochloride (HCl)<br>* Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration<br>* Other names: Lamisil;|
| Active Comparator: 2<br>Griseofulvin | Drug: Griseofulvin<br>* Griseofulvin pediatric suspension o.d. administration<br>* Other names: Grilfulvin V;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure (negative mycology and clinical cure) rate at Week 10 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate at Week 10 |  |  | 
| Mycological cure rate at Week 10 |  |  | 
| Safety of terbinafine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Terbinafine, Tinea capitis, pediatric, antifungal