Pharmacology Update: Luliconazole Cream 1% (Luzu®)

Pharmacology Update

Luliconazole Cream 1% (Luzu®)

By William T. Elliott, MD, FACP, and
James Chan, PharmD, PhD

Dr. Elliott is Chair, Formulary Committee, Northern
California Kaiser Permanente; and Assistant Professor
of Medicine, University of California, San Francisco.
Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA

Drs. Elliott and Chan report no financial relationships relevant to this field
of study.

A new azole antifungal cream has been approved for the treatment of Athlete's foot, jock itch, and ringworm infection. Luliconazole is manufactured by Medicis and marketed by Valeant Pharmaceuticals as Luzu.

Indications

Luliconazole is indicated for the topical treatment of interdigital tinea pedis (Athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) caused by Trichophyton rubrum and Epidermophyton floccosum in adults.¹

Dosage

For tinea pedis, the cream should be applied to the affected and immediate surrounding areas once daily for 2 weeks.¹ For tinea cruris and tinea corporis, the cream should be applied once daily for 1 week.

Luliconazole is available as a 1% cream in 30 g and 60 g tubes.

Potential Advantages

Luliconazole is the first topical azole antifungal to be approved for once-daily, 1-week treatment for tinea cruris and tinea corporis. Luliconazole's activity in vitro and in vivo is higher than terbinafine.^2,3,4

Potential Disadvantages

Contact dermatitis and cellulitis have been reported during post marketed use.¹ However, direct causality has not been established. It is available only by prescription compared to most commonly used topical antifungals that are over the counter.

Comments

The safety and efficacy of luliconazole in tinea pedis were evaluated in two randomized, double-blind, vehicle-controlled trials in 423 subjects. Subjects were randomized to luliconazole 1% or vehicle applied once daily for 14 days. Approximately 1 inch of cream was applied to all interdigital web spaces. The primary efficacy endpoint was complete clearance (clinical and mycological cure) at 4 weeks post-treatment. Complete clearance (vs vehicle) occurred in 26% (vs 2%) and 14% (vs 3%) in the two studies, respectively. Mycological cure rate was 62% (vs 18%) and 56% (vs 27%). For the treatment of tinea cruris, subjects were randomized to luliconazole 1% (n = 165) or vehicle (n = 91) applied once daily for 7 days. Complete clearance at 3 weeks post treatment was 21% for luliconazole (vs 4%). Mycological cure was 78% (vs 45%). Luliconazole cream is well tolerated with application site reactions occurring in less than 1% of subjects. A 4-week treatment of tinea pedis achieved complete clearance of 45.7% 2-weeks post treatment compared to 26.8% at 2 weeks post treatment after a 2-week treatment. Vehicle responses were 9.1% and 10%, respectively.⁵

Clinical Implications

Luliconazole cream is the newest azole antifungal to be approved. It has been available in Japan since 2005. It is a potent antifungal that is approved for a shorter treatment course for tinea cruris and tinea corporis than current commonly used antifungals such as terbinafine. Clinical cure (absence of erythema, scaling, and pruritus), however, is only 15-29% for tinea pedis and 24% for tinea cruris. A longer treatment appears to improve effectiveness. Luliconazole as a 10% solution has shown accumulation in the nail and is being studied for mild-to-moderate onychomycosis.6,7 Unlike other topical antifungals that are available over the counter, luliconazole is only available with a prescription. The wholesale cost of luliconazole cream was not available at the time of this review.

References

1. Luzu Prescribing Information. Bridgewater, NJ:
   Valeant Pharmaceuticals, Ltd.; November 2013.
2. Koga H, et al. Short-term therapy with luliconazole, a novel topical antifungal imidazole, in guinea pig models of tinea corporis and tinea pedis. Antimicrob Agents Chemother 2012;56:3138-3143.
3. Koga H, et al. In vitro antifungal activities of luliconazole, a new topical imidazole. Med Mycol 2009;47:
   640-647.
4. Koga H, et al. In vitro antifungal activity of luliconazole against clinical isolates from patients with dermatomycoses. J Infect Chemother 2006;12:163-165.
5. Jarratt M, et al. Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study. Cutis 2013;91:203-210.
6. Jones T, Tavakkol A. Safety and tolerability of luliconazole solution 10-percent in patients with moderate to severe distal subungual onychomycosis. Antimicrob Agents Chemother 2013;56:2684-2689.
7. http://clinicaltrials.gov/ct2/show/NCT01431820?term=luliconazole&rank=2. Accessed December 9, 2013.