Luliconazole 1% cream is a once-daily topical medication for
the treatment of interdigital tinea pedis, tinea cruris, and tinea
corporis. Luliconazole is a topical imidazole that inhibits sterol
14α-demethylase and subsequently prevents ergosterol
biosynthesis. It has broad-spectrum in-vitro antifungal activity
against dermatophytes and candida.30 As opposed to the
2-week treatment course needed for many other topical imidazoles,
luliconazole treatment course is only one week for tinea
cruris and tinea corporis indications. However, interdigital tinea
pedis indication still requires a two-week treatment course.
Topical luliconazole has been used for tinea pedis, tinea corporis,
and tinea cruris in Japan since 2005.
Several clinical trials have been performed using luliconazole
to treat tinea infections in the US. A double-blind vehicle control
study in the US evaluated interdigital tinea pedis treated
with luliconazole 1% cream. Patients used active drug or vehicle
once daily for two or four weeks. Complete clearance
rate and mycological cure rate after two or four weeks of
therapy with luliconazole 1% cream is seen in Tables 3 and
4.31-32 After two weeks of therapy, the mycological cure rate of
luliconazole was 58.5%, which increased to 78% two weeks
post-treatment, and then to 82.9% four weeks post-treatment
in the two-week active treatment group.32After four weeks of
therapy, the mycological cure rate of luliconazole was 77.1%,
which increased to 88.6% two weeks post-treatment and then
to 91.4% four weeks post-treatment in the four-week active
treatment group.32 Both treatment regimens were found to be
safe and well-tolerated with limited systemic absorption and
thus far no treatment related systemic side effects. Efficacy results
were comparative to those observed in Japan.33 Finally, a
separate study evaluating luliconazole efficacy for tinea cruris
revealed that once-daily application for one week treatment
yielded a 21% complete clearance rate, as compared to 4% on
vehicle at three weeks post-treatment.34
CONCLUSION
Both tinea pedis and onychomycosis are common skin infections
that can be a challenge to treat. Side effects and monitoring need
for oral anti-fungals have prompted the development of new
and more effective topical medications. Advances in formulation
technology has allowed for the development of more effective,
safer therapies that offer higher cure rates with shorter treatment
periods. These new medications offer additional options for patients
with resistant or recurrent disease or in those populations
who are noncompliant with previous longer therapies.
DISCLOSURES
Leon Kircik has received either grant or honorarium support
as an investigator, speaker, consultant, or advisory board
member from the following: Abbott Laboratories; Acambis;
Allergan, Inc.; Amgen, Inc.; Assos Pharma; Astellas Pharma
US, Inc.; Asubio Pharmaceuticals, Inc.; Berlex Laboratories
(Bayer Health Care Pharmaceuticals); Biogen Idec; Biolife; Biopelle;
Breckenridge Pharmaceuticals, Inc.; Colbar Life Science Ltd.;
Centocor, Inc.; CollaGenex Pharmaceuticals, Inc.; Combinatrix;
Connectics Corporation; Coria Laboratories; Dermik Laboratories;
Dow Pharmaceutical Sciences, Inc.; Dusa Pharmaceuticals,
Inc.; Embil Pharmaceuticals; EOS Pharmaceutical Corp.; Ferndale
Laboratories, Inc.; Galderma Laboratories, LP; Genentech,
Inc.; GlaxoSmithKline, PLC; Health Point; Intendis, Inc.; Inovail Healthcare;
Johnson & Johnson; Laboratory Skin Care Inc.; Leo Pharma;
3M; Medical International Technologies; Merck; Medicis Pharmaceutical
Corp.; Merz Pharmaceuticals; Nano Bio Corporation;
Novartis AG; Nucryst Pharmaceuticals Corp.; Obagi Medical;
Onset Dermatologics; OrthoNeutrogena; Promius; QLT, Inc.;
PharmaDerm; Pfizer Inc.; PuraCap; Quatrix; Serono (Merck Serono
International
SA); SkinMedica, Inc.; Stiefel Laboratories, Inc.; TolerRx;
Triax Pharmaceuticals; UCB; Valeant Pharmaceuticals
International;
Warner-Chilcott; and ZAGE. Joshua Zeichner has served
as an advisory board member for Anacor and a consultant for Valeant. Ethan T. Routt and Shelbi C. Jim On have not disclosed any relevant conflicts.