General Information

Luzu (luliconazole) Cream 1% is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.

Luzu is specifically indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in adults 18 years of age and older.

Luzu is supplied as a cream for topical administration. The recommended dose is as follows: Interdigital Tinea Pedis: Luzu Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for two weeks. Tinea Cruris and Tinea Corporis: Luzu Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for one week.

Clinical Results

FDA Approval
The FDA approval of Luzu was based on the following trials:
Interdigital Tinea Pedis:
The safety and efficacy of Luzu was evaluated in two randomized, double-blind, vehicle-controlled, multi-center clinical trials in 423 subjects with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Subjects were randomized to receive Luzu Cream, 1% or placebo, which was applied to the entire area of the forefeet including all interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 4 weeks post-treatment. Luzu Cream, 1% demonstrated complete clearance in subjects with interdigital tinea pedis. Study 1: 26% versus 2% and Study 2: 14% versus 3% for the Luzu versus placebo arms, respectively.
Tinea Cruris
A randomized, double-blind, vehicle-controlled, multi-center clinical trial in 256 subjects with a clinical and culture confirmed diagnosis of tinea cruris. Subjects were randomized to receive LUZU Cream, 1% or vehicle. Subjects applied either Luzu Cream 1% or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 3 weeks post-treatment. Luzu Cream, 1% demonstrated complete clearance in subjects with tinea cruris: 21% versus 4% for placebo.

Mechanism of Action