Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
NCT00117767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720
Last updated 2017-05-31
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
Interventions
- DRUG
-
Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
- DRUG
-
Griseofulvin
Griseofulvin pediatric suspension o.d. administration
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2006-03-31
Countries
- United States
Study Locations
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