title: Efinaconazole Topical Solution, 10%, for the Treatment of Mild and Moderate Toenail Onychomycosis.
abstract: OBJECTIVE
  To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10%, in patients with mild (≤25% nail involvement) and moderate (>25% nail involvement) toenail onychomycosis.
  
  
  METHODS
  A subgroup analysis of patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled, 48-week studies evaluating safety and efficacy. The primary endpoint 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 similar in mild and moderate onychomycosis patients treated with efinaconazole (58.2% and 55.5%, respectively), but markedly different with vehicle (25.0% and 14.1%, respectively). The primary endpoint, complete cure, was achieved in 25.8 percent of mild onychomycosis patients and 15.9 percent of moderate onychomycosis patients compared to 11.3 and 2.7 percent, respectively, with vehicle (both P<0.001). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 65.7 and 40.7 percent, respectively, depending on disease severity. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
  
  
  CONCLUSIONS
  Once-daily efinaconazole topical solution, 10%, may provide a useful topical option in the treatment of mild-to-moderate onychomycosis.
authors.affiliation: Dermatology Associates/Research, Coral Gables, Florida.
authors.forename: David A
authors.initials: DA
authors.lastname: Rodriguez