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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Primary Purpose

Tinea Capitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Terbinafine hydrochloride
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Capitis focused on measuring Terbinafine, Tinea capitis, pediatric, antifungal

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Complete cure (negative mycology and clinical cure) rate at Week 10

Secondary Outcome Measures

Clinical cure rate at Week 10
Mycological cure rate at Week 10
Safety of terbinafine

Full Information

First Posted
June 30, 2005
Last Updated
February 20, 2007
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00117754
Brief Title
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Official Title
Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Capitis
Keywords
Terbinafine, Tinea capitis, pediatric, antifungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
720 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Terbinafine hydrochloride
Primary Outcome Measure Information:
Title
Complete cure (negative mycology and clinical cure) rate at Week 10
Secondary Outcome Measure Information:
Title
Clinical cure rate at Week 10
Title
Mycological cure rate at Week 10
Title
Safety of terbinafine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com/webapp/etrials/home.do
Description
Novartis patient recruitment website

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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

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