Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Tinea Capitis Clinical Trial

Official title:

Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117754
• Other study ID #: SFO327C2302
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: February 20, 2007
• Start date: July 2004
• Est. completion date: April 2006

Study information

• Verified date: August 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Health Surveillance AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)India: Institutional Review BoardRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Capitis

Intervention

Drug:
• Terbinafine hydrochloride

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete cure (negative mycology and clinical cure) rate at Week 10
Secondary	Clinical cure rate at Week 10
Secondary	Mycological cure rate at Week 10
Secondary	Safety of terbinafine