Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

NCT00117754 | Completed Phase 3

• 1 other identifier: SFO327C2302
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Capitis

Keywords

Terbinafine, Tinea capitis, pediatric, antifungal

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Clinical cure rate at Week 10

• Mycological cure rate at Week 10

• Safety of terbinafine

Interventions

Terbinafine hydrochloride DRUG

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Novartis patient recruitment website

MeSH Terms

Conditions

Tinea Capitis

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Scalp Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 8, 2005
• Study Start: July 1, 2004
• Study Completion: April 1, 2006
• Last Updated: February 21, 2007

Record last verified: 2006-08

Locations

US (1)