Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis
June 2016 | Volume 15 | Issue 6 | Original Article | 743 | Copyright © June 2016
Michael Gold MD,a Sunil Dhawan MD,b Amit Verma DrPH MPH,c Michael Kuligowski MD PhD MBA,c and David Dobrowskic
aTennessee Clinical Research Center, Nashville, TN
bCenter for Dermatology, Cosmetic, and Laser Surgery, Inc. and Center for Dermatology Clinical Research, Inc., Fremont, California and Milpitas, CA
cMerz North America, Inc.; Raleigh, NC
Abstract
BACKGROUND: Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects.
OBJECTIVE: To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.
METHODS: At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 3 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 231 subjects (n=116, naftifine; n=115, vehicle).
RESULTS: Children with tinea corporis treated with naftifine cream 2% demonstrated significantly greater improvements from baseline over vehicle for mycological cure (
P<0.0001) and treatment effectiveness (
P=0.003) as early as 2 weeks (end of treatment). Response rates continued to increase post-treatment and were the highest 1-week after completion of the therapy (
P=0.003 for complete cure; and
P<0.001 for mycological cure and treatment effectiveness). Treatment related adverse events were minimal.
CONCLUSIONS: Treatment with naftifine cream 2% applied once daily for two weeks was well-tolerated and was effective in treating tinea corporis in children. Further improvement was observed 1-week after treatment completion for all key outcome measures (complete cure, mycological cure, treatment effectiveness, clinical cure, and clinical success) and clinical signs and symptoms (erythema, induration, and pruritus).
J Drugs Dermatol. 2016;15(6):743-748.
INTRODUCTION
Tinea corporis is a dermatophyte infection of the glabrous skin of the trunk and/or extremities. The disease is found worldwide and affects persons of all age groups, but the prevalence is the highest in preadolescents.1,2 The degree of inflammation associated with the condition depends on whether the fungus is zoophilic or anthropophilic. In zoophilic species such as Microsporum canis, tinea corporis usually presents with erythematous scaly circinate lesions and raised boarders. Pustules are not uncommon. Most of the fungal skin infections in humans are caused by Trichophyton rubrum and present with defined margins that are often scaly but not necessarily very erythematous. Other pathogenic dermatophytes include Trichophyton mentagrophytes and Trichophyton tonsurans.1,3,4
Treatment options include oral or topical drug therapies. Although oral treatments are an option in the treatment of tinea
corporis, typically this condition is easily manageable with topical therapy. Owing primarily to systemic safety considerations, oral therapy should only be considered in noncompliant subjects or when the infection affects a large area of the body, especially in immunocompromised individuals.5-7
Naftifine, an allylamine, has anti-fungal as well as antibiotic activity.8,9 In clinical trials, naftifine hydrochloride (HCl) was shown to be more efficacious than other topical options with a lower incidence of side effects and a faster resolution of symptoms.10 Naftifine HCL cream 2% is currently approved for the treatment of tinea cruris, tinea corporis, and tinea pedis; however, clinical data using topical naftifine for tinea corporis in a pediatric population is limited. The objective of this manuscript is to present the results from a well-controlled trial that evaluated the efficacy and safety of naftifine cream 2% in pediatric subjects with tinea corporis.
