Clinical trial NCT00117767: Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Official title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Capitis
Keywords: Terbinafine, Tinea capitis, pediatric, antifungal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-07-08
Enrollment: 720
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete cure (negative mycology and clinical cure) rate at Week 10
Secondary outcomes:
measure: Clinical cure rate at Week 10
measure: Mycological cure rate at Week 10
measure: Safety of terbinafine
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
References:
citation: 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.