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: NCT00117767
• Other study ID #: CSFO327C2301
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: May 28, 2017
• Start date: June 2004

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Tinea
• Tinea Capitis

Intervention

Drug:
• Terbinafine hydrochloride (HCl)
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
• Griseofulvin
Griseofulvin pediatric suspension o.d. administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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

External Links

•   Results available for CSFO327C2301 at Novartis Clinical Trials Database