Efficacy and safety of luliconazole 5% nail solution for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study.
Onychomycosis is a highly prevalent and intractable disease. The first-line treatment agents are oral preparations, but an effective topical medication has long been desired. The objective was to investigate the efficacy and safety of luliconazole 5% nail solution, an imidazole antifungal agent, for the treatment of patients with onychomycosis. A multicenter, double-blind, randomized phase III study was conducted in Japanese patients with distal lateral subungual onychomycosis affecting the great toenails, with 20-50% clinical involvement. Patients were randomized (2:1) to luliconazole or vehicle once daily for 48 weeks. The primary end-point was the complete cure rate (clinical cure [0% clinical involvement of the nail] plus mycological cure [negative results on direct microscopy]). The adverse event incidence was monitored to evaluate safety. The complete cure rate significantly favored luliconazole (14.9%, 29/194 subjects) versus vehicle (5.1%, 5/99) (P = 0.012). Similarly, the negative direct microscopy rate was significantly higher with luliconazole (45.4%, 79/174) than with vehicle (31.2%, 29/93) (P = 0.026). There were no serious adverse drug reactions. We conclude that once daily topical luliconazole 5% nail solution demonstrated clinical efficacy and was confirmed to be well tolerated.
Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
Shinichi
S
Watanabe
Sato Pharmaceutical, Tokyo, Japan.
Hiroshi
H
Kishida
Sato Pharmaceutical, Tokyo, Japan.
Akihiro
A
Okubo
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008853:Microscopy; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D019999:Pharmaceutical Solutions / Q000627:therapeutic use; D014005:Tinea / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016896:Treatment Outcome; D014249:Trichophyton / Q000187:drug effects* / Q000302:isolation & purification; D055815:Young Adult
D000935:Antifungal Agents; D007093:Imidazoles; D019999:Pharmaceutical Solutions; C112528:luliconazole
administration topical; antifungal agents; luliconazole; onychomycosis; randomized controlled trial