title: Efinaconazole 10% solution in the treatment of onychomycosis of the toenails.
abstract: BACKGROUND
  Efinaconazole 10% solution is a new triazole antifungal agent developed for the topical treatment of onychomycosis. This article reviews the pooled results of the two pivotal clinical trials of this drug that have been performed in the United States, Canada, and Japan.
  
  
  METHODS
  The two studies of 1,655 patients were both double-blind, vehicle-controlled, parallel-group, randomized, multicenter studies designed to determine the efficacy and safety of efinaconazole 10% solution in the treatment of mild-to-moderate onychomycosis of the toenails caused by dermatophytes. Treatment was provided once daily for 48 weeks, and the primary end point was at week 52.
  
  
  RESULTS
  The combined results show a 56% mycologic cure rate compared with 17% for vehicle at week 52. Clinical treatment success was achieved in 43% of patients treated with efinaconazole 10% solution at follow-up (week 52). Clinical treatment success was achieved in 47% of patients. As expected for a topical agent, the use of efinaconazole 10% solution was found to be safe, with mild, transient irritation at the site of application reported as the most common adverse event.
  
  
  CONCLUSIONS
  The efficacy and safety profile of efinaconazole 10% solution suggests that it may represent an important advance in the topical treatment of onychomycosis. Further studies will help us better understand the role of this agent for the treatment of this widespread podiatric medical condition.
authors.forename: Warren S
authors.initials: WS
authors.lastname: Joseph
authors.forename: Tracey C
authors.initials: TC
authors.lastname: Vlahovic
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Pillai
authors.forename: Jason T
authors.initials: JT
authors.lastname: Olin
mesh_terms: D000287:Administration, Topical; D000935:Antifungal Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D014009:Onychomycosis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D000935:Antifungal Agents; D014230:Triazoles; C431707:efinaconazole