Amorolfine Nail Lacquer 5 % Once Weekly in Onychomycosis of Fingers and / or Toes

Eun, Hee Chul; Lee, My Hyoung; Kim, Soo Nam; Yoo, Hee Joon; Kwon, Kyung Sool; Kim, Soo Chan; Lee, Jae Seung; Kim, Bang Soon; Chung, Byoung Soo; Chang, Seung Ho; Park, Chun Wook

Abstract

BACKGROUND: Amorolfine is a new topical antifungal drug of the morpholine class has broad spectrum fungicidal activity. Amorolfine nail lacquer 5% is a transungual delivery system which can penetrate well through the nail plate to the infected keratin and remain there for a prolonged period.
OBJECTIVE
The aim of this study is to assess the efficacy and tolerability of 5% amorolfine nail lacquer given once weekly to the patients with onychomycosis.
METHODS
29 patients with onychomycosis affecting not more than 80% of the surface of nail were treated once weekly for up to 9 months with amorolfine nail lacquer 5%. Clinical and mycological examination were performed before treatment and 3, 6, 9 months after start of treatment. Final evaluation was done 3 months after the end of treatment.
RESULTS
Average affected area(%) and average score of clinical signs-thickening, splitting, discoloration-were significantly decreased 3 months after start of treatment. Mycological cure rate was continuously increased according to the treatment duration reaching 75.9% at 3 months after treatment. Overall efficacy assessed by the investgators were cure in 31.0% and improvement in 41.4%. Tolerability, mode and frequency of treatment, and formulation were evaluated as good or excellent by most of the patients.No systemic or local side effect was observed.
CONCLUSION
Amorolfine nail lacquer 5% used once weekly up to 9 months was relatively effective and safe for the treatment of onychomycosis.