title: Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies.
abstract: BACKGROUND
  Onychomycosis is a common nail infection, often resulting in nail plate damage and deformity. Topical lacquer treatments have negligible efficacy. Oral treatments, although more efficacious, are limited by drug interactions and potential hepatotoxicity.
  
  
  OBJECTIVE
  We investigated the safety and efficacy of efinaconazole 10% solution (efinaconazole), the first triazole antifungal developed for distal lateral subungual onychomycosis.
  
  
  METHODS
  Two identical, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in patients with toenail distal lateral subungual onychomycosis (20%-50% clinical involvement [study 1: N = 870, study 2: N = 785]). Patients were randomized (3:1) to efinaconazole or vehicle, once daily for 48 weeks, with 4-week posttreatment follow-up. Debridement was not performed. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.
  
  
  RESULTS
  Mycologic cure rates were significantly greater with efinaconazole (study 1: 55.2%, study 2: 53.4%) compared with vehicle (P < .001). The primary end point, complete cure, was also significantly greater for efinaconazole (study 1: 17.8% vs 3.3%, study 2: 15.2% vs 5.5%, P < .001). Treatment success (percent affected target toenail [0%-≤10%]) for efinaconazole ranged from 21.3% to 44.8% in study 1 and from 17.9% to 40.2% in study 2, compared with 5.6% to 16.8% and 7.0% to 15.4%, respectively, with vehicle. Adverse events associated with efinaconazole were local site reactions (2%) and clinically similar to vehicle.
  
  
  CONCLUSIONS
  A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
  
  
  CONCLUSIONS
  Once daily topical efinaconazole appears to be a viable alternative to oral treatment options for onychomycosis.
authors.affiliation: Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama. Electronic address: beelewski@aol.com.
authors.forename: Boni E
authors.initials: BE
authors.lastname: Elewski
authors.affiliation: Northwest Cutaneous Research Specialists, Portland, Oregon.
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.affiliation: San Antonio Podiatry Associates, San Antonio, Texas.
authors.forename: Richard
authors.initials: R
authors.lastname: Pollak
authors.affiliation: Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia.
authors.forename: David M
authors.initials: DM
authors.lastname: Pariser
authors.affiliation: Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Watanabe
authors.affiliation: Kaken Pharmaceutical Co Ltd, Kyoto, Japan.
authors.forename: Hisato
authors.initials: H
authors.lastname: Senda
authors.affiliation: Kaken Pharmaceutical Co Ltd, Tokyo, Japan.
authors.forename: Chikara
authors.initials: C
authors.lastname: Ieda
authors.affiliation: Dow Pharmaceutical Sciences Inc, (a division of Valeant Pharmaceuticals North America LLC) Petaluma, California.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Smith
authors.affiliation: Dow Pharmaceutical Sciences Inc, (a division of Valeant Pharmaceuticals North America LLC) Petaluma, California.
authors.forename: Radhakrishnan
authors.initials: R
authors.lastname: Pillai
authors.affiliation: Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
authors.forename: Tage
authors.initials: T
authors.lastname: Ramakrishna
authors.affiliation: Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
authors.forename: Jason T
authors.initials: JT
authors.lastname: Olin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D014230:Triazoles / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D014230:Triazoles; C431707:efinaconazole