Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

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ClinicalTrials.gov Identifier: NCT00117767

Recruitment Status : Completed

First Posted : July 8, 2005

Last Update Posted : May 31, 2017

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease	Intervention/treatment	Phase
Tinea Capitis	Drug: Terbinafine hydrochloride (HCl) Drug: Griseofulvin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	720 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Study Start Date :	June 2004
Actual Primary Completion Date :	March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Drug Information available for: Griseofulvin Terbinafine hydrochloride Terbinafine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 12 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117767

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

Publications:

Elewski BE, Cáceres 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.

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Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117767
Other Study ID Numbers:	CSFO327C2301
First Posted:	July 8, 2005 Key Record Dates
Last Update Posted:	May 31, 2017
Last Verified:	May 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):


Terbinafine, Tinea capitis, pediatric, antifungal

Additional relevant MeSH terms:

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

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