Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Study Description

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Clinical cure rate at Week 10
2. Mycological cure rate at Week 10
3. Safety of terbinafine

Eligibility Criteria

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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

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Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Results available for CSFO327C2301 at Novartis Clinical Trials Database 

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 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