Efficacy of debridement alone versus debridement combined with topical antifungal nail lacquer for the treatment of pedal onychomycosis: a randomized, controlled trial

J Foot Ankle Surg. 2009 May-Jun;48(3):294-308. doi: 10.1053/j.jfas.2008.12.012.


Pedal onychomycosis is a common malady caused by dermatophytes, saprophytes, and yeasts. Traditional treatment options for this condition include toenail debridement, and pharmacological therapies that range from the application of topical agents to the oral administration of antifungal medications. In this study, 55 patients (289 toenails) were randomly allocated to either nail debridement (27 [49.09%] patients) or debridement plus application of topical antifungal nail lacquer (28 [50.91%] patients). The primary outcome was mycological cure, and secondary outcomes included foot-related quality of life, and a number of clinically important toenail characteristics. After a median follow-up of 10.5 months (range, 3.25-14.25) months), patients in the antifungal nail lacquer group improved statistically significantly more than did those in the debridement alone group, and displayed a 76.74% rate of mycological cure. None of the patients in the debridement-only group experienced mycological cure. Variables that statistically significantly decreased the likelihood of cure included yeast on culture, pedal hyperhidrosis, cigarette smoking, involvement of the lunula, and involvement of >50% of the transverse width of the nail. Variables statistically significantly associated with an increased likelihood of cure included intervention before 6 months' duration, treatment at a large, urban practice, black race, and loss of protective sensation.

Level of clinical evidence: 1.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Antifungal Agents / therapeutic use*
  • Black People
  • Ciclopirox
  • Debridement*
  • Female
  • Foot Dermatoses / microbiology
  • Foot Dermatoses / pathology
  • Foot Dermatoses / therapy*
  • Humans
  • Hyperhidrosis / complications
  • Male
  • Middle Aged
  • Onychomycosis / pathology
  • Onychomycosis / therapy*
  • Pyridones / therapeutic use*
  • Risk Factors
  • Single-Blind Method
  • Smoking / adverse effects
  • Time Factors
  • Treatment Outcome
  • Urban Health Services


  • Antifungal Agents
  • Pyridones
  • Ciclopirox