Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00117767

First Posted: July 8, 2005

Last Update Posted: May 31, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

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 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

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 ( Novartis Pharmaceuticals ):

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

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


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

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

Additional Information:

Results available for CSFO327C2301 at Novartis Clinical Trials Database This link exits the ClinicalTrials.gov site

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.


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00117767 History of Changes
Other Study ID Numbers:	CSFO327C2301
First Submitted:	June 30, 2005
First Posted:	July 8, 2005
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:


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

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