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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 (HCl)
Griseofulvin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Terbinafine

Griseofulvin

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
May 28, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00117767
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
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

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
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
720 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Terbinafine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Griseofulvin
Intervention Type
Drug
Intervention Name(s)
Terbinafine hydrochloride (HCl)
Other Intervention Name(s)
Lamisil
Intervention Description
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
Intervention Type
Drug
Intervention Name(s)
Griseofulvin
Other Intervention Name(s)
Grilfulvin V
Intervention Description
Griseofulvin pediatric suspension o.d. administration
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

Citations:
PubMed Identifier
18378354
Citation
Elewski BE, Caceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, Sanchez-Bal V, Todd G, Wraith L, Cai B, Tavakkol A, Bakshi R, Nyirady J, Friedlander SF. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol. 2008 Jul;59(1):41-54. doi: 10.1016/j.jaad.2008.02.019. Epub 2008 Apr 18.
Results Reference
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Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

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