Pilot study of tolerability and safety of combination product containing terbinafne hydrochloride and econazole nitrate

Abstract

Therapy of onychomycosis today presents a number of diffculties, and the effect does not always meet the expectations of patients. The purpose of the study. To study the tolerability and safety of the use of the drug Exilac(terbinafne hydrochloride + econazole nitrate), medical nail polish for external use. Methods. Eighteen volunteers participated in a pilot, prospective, monocentre, open-label tolerability and safety study. The study lasted 6 weeks and consisted of screening and fve visits, at each visit a visual examination, laboratory and instrumental examination methods were performed. Results. Eighteen healthy volunteers aged 18 to 34 participated in the study. Adverse events associated with the application of the study drug Exilac were observed in 1 (5.56%) volunteer, in the form of signs of delamination of the nail plate of the 1st fnger. This phenomenon is associated with mechanical damage to the nail plate when removing the old layer of the study drug and was regarded as a minor adverse event of mild severity. The remaining adverse events were not related to the use of the drug. Conclusion. The combined drug Exilac, when used twice daily for 6 weeks, demonstrated a high level of tolerability and safety.