Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

NCT ID: NCT00117767

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Terbinafine

Group Type: EXPERIMENTAL

Terbinafine hydrochloride (HCl)

Intervention Type: DRUG

Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration

2

Griseofulvin

Group Type: ACTIVE_COMPARATOR

Griseofulvin

Intervention Type: DRUG

Griseofulvin pediatric suspension o.d. administration

Interventions

Terbinafine hydrochloride (HCl)

Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration

Intervention Type: DRUG

Griseofulvin

Griseofulvin pediatric suspension o.d. administration

Intervention Type: DRUG

Other Intervention Names

Lamisil; Grilfulvin V

Eligibility 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

References

Elewski BE, Caceres 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.

Reference Type: BACKGROUND

PMID: 18378354 (View on PubMed)

Other Identifiers

CSFO327C2301

Identifier Type: -

Identifier Source: org_study_id