Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study

Cutis. 2013 Apr;91(4):203-10.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use*
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Imidazoles / administration & dosage
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Time Factors
  • Tinea Pedis / drug therapy*
  • Treatment Outcome
  • Young Adult

Substances

  • Antifungal Agents
  • Imidazoles
  • luliconazole