title: Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies.
abstract: BACKGROUND
  Onychomycosis, a fungal nail infection, can impact quality of life.
  
  
  OBJECTIVE
  We sought to evaluate the efficacy and safety of tavaborole topical solution, 5% for treatment of toenail onychomycosis.
  
  
  METHODS
  In 2 phase-III trials, adults with distal subungual onychomycosis affecting 20% to 60% of a target great toenail were randomized 2:1 to tavaborole or vehicle once daily for 48 weeks. The primary end point was complete cure of the target great toenail (completely clear nail with negative mycology) at week 52. Secondary end points included completely or almost clear nail, negative mycology, completely or almost clear nail plus negative mycology, and safety.
  
  
  RESULTS
  Rates of negative mycology (31.1%-35.9% vs 7.2%-12.2%) and complete cure (6.5% and 9.1% vs 0.5% and 1.5%) significantly favored tavaborole versus vehicle (P ≤ .001). Completely or almost clear nail rates also significantly favored tavaborole versus vehicle (26.1%-27.5% vs 9.3%-14.6%; P < .001). Rates of completely or almost clear nail plus negative mycology (15.3%-17.9% vs 1.5%-3.9%) were significantly greater for tavaborole versus vehicle (P < .001). Application-site reactions with tavaborole included exfoliation (2.7%), erythema (1.6%), and dermatitis (1.3%).
  
  
  CONCLUSIONS
  Duration of follow-up is a limitation.
  
  
  CONCLUSIONS
  Tavaborole demonstrates a favorable benefit-risk profile in treatment of toenail onychomycosis.
authors.affiliation: Department of Dermatology, University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: beelewski@aol.com.
authors.forename: Boni E
authors.initials: BE
authors.lastname: Elewski
authors.affiliation: Department of Dermatology, University of California, San Francisco, California.
authors.forename: Raza
authors.initials: R
authors.lastname: Aly
authors.affiliation: Anacor Pharmaceuticals, Inc, Palo Alto, California.
authors.forename: Sheryl L
authors.initials: SL
authors.lastname: Baldwin
authors.affiliation: Centro de Dermatologia de Monterrey, Monterrey, Mexico.
authors.forename: Remigio F
authors.initials: RF
authors.lastname: González Soto
authors.affiliation: Oregon Health and Science University, Portland, Oregon.
authors.forename: Phoebe
authors.initials: P
authors.lastname: Rich
authors.affiliation: Hamilton Foot Care, Baltimore, Maryland.
authors.forename: Max
authors.initials: M
authors.lastname: Weisfeld
authors.affiliation: FXM Research Corp, Miami, Florida.
authors.forename: Hector
authors.initials: H
authors.lastname: Wiltz
authors.affiliation: Centro de Dermatologia de Monterrey, Monterrey, Mexico.
authors.forename: Lee T
authors.initials: LT
authors.lastname: Zane
authors.affiliation: Endeavor Clinical Trials, San Antonio, Texas.
authors.forename: Richard
authors.initials: R
authors.lastname: Pollak
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001896:Boron Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D001896:Boron Compounds; D019086:Bridged Bicyclo Compounds, Heterocyclic; C512998:tavaborole
keywords: antifungal agents; arthrodermataceae; nails; onychomycosis; randomized controlled trial; tavaborole