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 | Journal 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-
