title: Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study.
abstract: Tinea pedis (TP) typically is treated with topical antifungal agents. Luliconazole, a novel imidazole drug, is shown to be as or more effective in vitro and in vivo than bifonazole, terbinafine, and lanoconazole. Two treatment durations with luliconazole cream 1% were evaluated for treatment of TP. Participants with interdigital TP were randomized (N= 147) and treated with either luliconazole or its vehicle for either 2 or 4 weeks. The primary efficacy end point was the proportion of participants achieving complete clearance 2 weeks following completion of treatment. In the 2-week active treatment group, complete clearance was achieved in 26.8% (11/41) of participants versus 9. 1% (2/22) in the 2-week vehicle group at 2-weeks posttreatment. In the 4-week active treatment group, 45.7% (16/35) achieved complete clearance versus 10.0% (2/20) in the 4-week vehicle group at 2-weeks posttreatment. Twenty-three adverse events (AEs) were reported; most were mild (56.5% [13/23]) to moderate (26. 1% [6/23]) in severity. All reported AEs were determined to be unrelated (78.3% [18/23]) or unlikely related (21.7% [5/23]) to the study medication. The results of this study indicate that luliconazole cream 1% applied once daily for either 2 or 4 weeks is safe and effective for treatment of TP. More importantly, the antifungal effects of luliconazole persist for several weeks, resulting in increased rates of mycological cure.
authors.affiliation: DermResearch Inc, Austin, Texas, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Jarratt
authors.forename: Terry
authors.initials: T
authors.lastname: Jones
authors.forename: Steven
authors.initials: S
authors.lastname: Kempers
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.forename: Katy
authors.initials: K
authors.lastname: Morton
authors.forename: Norifumi
authors.initials: N
authors.lastname: Nakamura
authors.forename: Amir
authors.initials: A
authors.lastname: Tavakkol
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013997:Time Factors; D014008:Tinea Pedis / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D007093:Imidazoles; C112528:luliconazole