Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States

Ciclopirox 8% nail lacquer has recently become the first topical antifungal agent to be approved by the US Food and Drug Administration for the treatm ent of onychomycosis. This article reviews the results of the two pivotal c linical trials of this drug that have been performed in the United States a s well as those that have been carried out in other countries. The two US s tudies were both double-blind, vehicle-controlled, parallel-group, multicen ter studies designed to determine the efficacy and safety of ciclopirox nai l lacquer in the treatment of mild-to-moderate onychomycosis of the toenail s caused by dermatophytes. The combined results show a 34% mycologic cure r ate, as compared with 10% for the placebo. Data from the ten studies conduc ted worldwide show a meta-analytic mean ( SE) mycologic cure rate of 52.6% +/- 4.2%. As expected for a topical agent, ciclopirox nail lacquer was foun d to be extremely safe, with mild, transient irritation at the site of appl ication reported as the most common adverse event. Ciclopirox nail lacquer may also have potential for use in combination or adjunctive therapy. Furth er studies will help to better position this agent for the treatment of thi s widespread podiatric condition.