Efficacy and Safety of Once-Daily Luliconazole 1% Cream in Patients ≥12 Years of Age With Interdigital Tinea Pedis: A Phase 3, Randomized, Double-Blind,Vehicle-Controlled Study

July 2014 | Volume 13 | Issue 7 | Original Article | 838 | Copyright © July 2014

Michael Jarratt MD,a Terry Jones MD,b Jeffrey Adelglass MD FACS,c Alicia Bucko DO JD,d Richard Pollak
DPM MS,e Amaury Roman-Miranda MD,f Jason T. Olin PhD,g Leonard Swinyer MD FAADh

aDermResearch, Inc., Austin, TX
bJ & S Studies, Inc., College Station, TX
cResearch Across America, Dallas, TX
dAcademic Dermatology Associates, Albuquerque, NM
eSan Antonio Podiatry Associates, San Antonio, TX
fAdvanced Medical Concepts PSC, Cidra, Puerto Rico
gValeant Dermatology, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ
hDermatology Research Center, Inc., Salt Lake City, UT

Abstract
BACKGROUND: Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis.
OBJECTIVE: This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis.
METHODS: A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (ie, days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments.
RESULTS: Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P<0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle.
LIMITATIONS: This study was conducted in a relatively small population under controlled clinical trial conditions.
CONCLUSION: Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

J Drugs Dermatol. 2014;13(7):838-846.

INTRODUCTION

Tinea pedis is a common fungal infection affecting the interdigital regions of the feet.1,2 Its spread is facilitated by contact with contaminated footwear and flooring, poor hygiene, exposure to sweat, moist environments, and impaired immunity.3-6 The dominant causative agents for tinea pedis include Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.7,8 However, Candida species also can cause tinea pedis in certain patients (eg, diabetics).5
Topical treatment can be effective with an azole for ≤4 weeks or an allylamine for ≤2 weeks.1 Roughly 70% of patients experience recurrence owing to reinfection or persistence of dermatophytes on the skin.9 Moreover, patients with a history of tinea pedis are at significantly increased risk for onychomycosis. 10,11 Early treatment and fungal eradication in high-risk groups (e.g., diabetics, sports enthusiasts, active adolescents) may reduce the risk of both recurrence of tinea pedis and the development of onychomycosis.10,11
Luliconazole cream 1% is a broad-spectrum imidazole antimycotic agent, which unlike other imidazoles, has a dithiolan structure imparting high potency against filamentous fungi.12 Luliconazole cream 1% was approved in Japan in 2005 and in the USA in 2013 for the treatment of tinea pedis and tinea cruris. Extensive safety information on its use has been gathered in Japan, with approximately 10.8 million patients exposed to luliconazole cream 1% as of April 2011.13 The objective of this study, conducted in the USA, was to evaluate the safety and efficacy of luliconazole cream 1% applied once daily for 14 days in patients with interdigital tinea pedis.

METHODS

Study Design

This was a randomized, double-blind, parallel group, vehiclecontrolled, multicenter phase 3 study conducted at 12 US sites. Patients eligible for treatment were randomized 1:1 to treatment with luliconazole cream 1% or vehicle cream (Figure 1). The pro-