Clinical trials of lasers for toenail onychomycosis: The implications of new regulatory guidance.

Abstract

Despite the fact that lasers are presently indicated for the cosmetic outcome "temporary increase in clear nail", these devices are increasingly used to treat onychomycosis and particularly in patients who are unwilling or unable to take oral antifungal medication. The US Food and Drug Administration (FDA) recently issued draft guidance for medical device trials for onychomycosis. This review evaluates the quality of laser trials for onychomycosis and compares the design guidelines for medical d