A phase II study of the efficacy, tolerability and consumer acceptability of a 1% w/w terbinafine topical spray versus a currently marketed terbinafine product in the once only treatment of tinea pedis

Abstract

A novel topical metered dose aerosol (MDA) spray that delivers terbinafine hydrochloride to human skin for the treatment of tinea pedis (athlete's foot) has been developed. The drug product is manufactured as a solution that, upon actuation, assembles into a microfine occlusive film. The film produces a highly supersaturated system that dramatically increases drug diffusion across the superficial layers of human skin. The aim of the clinical study was to demonstrate the non-inferiority of the developed MDA (1% w/w terbinafine) spray compared with the marketed leading product (1% w/w terbinafine) after one application determined by the proportion of patients categorised as successfully treated at week 1. In addition, the secondary aims were to assess the tolerability, recurrence/relapse rate and consumer acceptability. The study was a randomised, observer-blind, comparative phase IIa study employing 120 patients with notable or prominent visual signs and symptoms of tinea pedis. The treatment success rates based on physician's global assessment of signs and symptoms for the novel spray formulation and the marketed product were not significantly different at one week; as such, non-inferiority was confirmed. Statistically comparable results were also observed for most of the other efficacy tests, whereas somewhat better results were seen for the erythema and microscopy (KOH) parameters for the novel MDA spray