Application of cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: results of a randomised active‐controlled study and in vitro assays

Abstract

SummaryAs onychomycosis is unsightly, this study clinically evaluated whether the antifungal efficacy of amorolfine 5% nail lacquer (NL) was affected by a masking, naturalcoloured, cosmetic nail varnish applied 24 h later; in vitro investigations were also performed. Subjects with mild-to-moderate distal subungual toenail onychomycosis were randomised to receive amorolfine 5% NL once weekly with or without cosmetic nail varnish applied 24 h later. After 12-week treatment, antifungal activity of affected toenail clippings was assessed by measurement of zones of inhibition (ZOIs) on Trichophyton mentagrophytes seeded agar plates. Mean diameters were 53.5 mm for the amorolfine 5% NL-alone group (n = 23) and 53.6 mm for amorolfine 5% NL plus cosmetic nail varnish group (n = 25). Also, mycological cultures of subungual debris at week 12 were negative for all subjects in both groups. Most subjects (88%) reported that cosmetic nail varnish masked their infected toenails. Additionally, cadaver human nails coated in vitro with or without cosmetic nail varnish 10 min or 24 h post amorolfine NL application all gave ZOIs on Trichophyton rubrum agar plates representing potent antifungal activity. In conclusion, cosmetic nail varnish applied post amorolfine had no effect on the subungual antifungal activity of amorolfine 5% NL or its penetration through toenails.

Efficacy and tolerability of amorolfine 5% nail lacquer in combination with systemic antifungal agents for onychomycosis: A meta-analysis and systematic review

“…Furthermore, lacquer is a form of drug which can maintain proper concentration of the active substance on the nail surface, and it just need to be applied once or twice weekly, which is of great convenience. And cosmetic nail varnishes would not affect the antifungal efficacy and can be applied concomitantly with amorolfine in the treatment of onychomycosis (Sigurgeirsson et al, ).Long‐term use of amorolfine lacquer, once every 2 weeks, was found to be effective in prophylaxis of onychomycosis recurrence in patients earlier treated with terbinafine in monotherapy or combined with amorolfine (Sigurgeirsson et al, ). A clinical study (Zhang et al, ) also suggested that combination therapy of a fractional 2,940‐nm Er: YAG laser and 5% amorolfine lacquer is an effective, safe, and convenient treatment method for onychomycosi.…”

Race reporting and representation in onychomycosis clinical trials: A systematic review

“…Of the 302 PubMed initial search results, 182 clinical trials (28,352 participants) met inclusion criteria and were included in the final analysis 6–186 . The PRISMA study selection process is detailed in Figure 1.…”

Ciclopirox Hydroxypropyl Chitosan (CPX-HPCH) Nail Lacquer and Breathable Cosmetic Nail Polish: In Vitro Evaluation of Drug Transungual Permeation Following the Combined Application

“…Table 6 summarizes the experimental conditions of the studies performed by the different research groups on these drugs. Sigurgeirsson et al [ 26 ] have demonstrated that the application of the cosmetic nail varnish does not affect the antifungal efficacy of amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis. This clinical study compared the therapeutic effect on two groups of patients, one treated for 12 weeks with amorolfine 5% nail lacquer alone, the other with amorolfine 5% nail lacquer plus a cosmetic nail varnish; the latter applied 24 h after the medicated lacquer.…”