Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00117767

First received: June 30, 2005

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Tinea Capitis	Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Resource links provided by NLM:

MedlinePlus related topics: Tinea Infections

Drug Information available for: Griseofulvin Terbinafine hydrochloride Terbinafine

U.S. FDA Resources

Further study details as provided by Novartis:

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


Estimated Enrollment:	720
Study Start Date:	June 2004
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Terbinafine	Drug: Terbinafine hydrochloride (HCl) Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration Other Name: Lamisil
Active Comparator: 2 Griseofulvin	Drug: Griseofulvin Griseofulvin pediatric suspension o.d. administration Other Name: Grilfulvin V

Eligibility


Ages Eligible for Study:	4 Years to 12 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117767

Locations


United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117767 History of Changes
Other Study ID Numbers:	CSFO327C2301
Study First Received:	June 30, 2005
Last Updated:	November 1, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Peru: General Directorate of Pharmaceuticals, Devices, and Drugs South Africa: Medicines Control Council

Keywords provided by Novartis:


Terbinafine, Tinea capitis, pediatric, antifungal

Additional relevant MeSH terms:


Tinea Tinea Capitis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases	Scalp Dermatoses Terbinafine Griseofulvin Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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