Topical Therapy for Toenail Onychomycosis: An Evidence-Based Review

NewsBot · Sep 30, 2014

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Topical Therapy for Toenail Onychomycosis: An Evidence-Based Review
Aditya K. Gupta, Deanne Daigle, Kelly A. Foley
American Journal of Clinical Dermatology; September 2014

Background
Managing toenail onychomycosis with topical treatments is challenging. It is difficult for topical medication to penetrate the nail plate, and this is reflected in lower cure rates with topical treatment than with oral treatment. However, oral medications may not be suitable for some patients, because of drug interactions; therefore, topical treatments are critical in managing the disease in certain patient populations.
Objective
This paper reviews the quality and content of the scientific literature on topical treatments for toenail onychomycosis.
Methods
PubMed, Ovid (Medline and Embase), Scopus, Cochrane library, and clinicaltrials.gov databases were searched for original clinical reports of topical monotherapy for microscopy and/or culture-confirmed toenail onychomycosis in adults. Studies were evaluated using an onychomycosis study quality scale, which was based on the CONSORT guidelines.
Results
Twenty-five publications (28 studies) were identified and met the inclusion criteria. Thirteen studies scored high ratings on the quality scale. These were randomized controlled trials or randomized comparative trials. Low-quality studies were nonrandomized, open studies that prevented statistical analysis. Most studies reported clinical and mycological cure. The most variation was observed with reporting outcomes of clinical improvement. Amorolfine, ciclopirox, tavaborole, and efinaconazole produced clinical and mycological cure in patients with mild to moderate toenail onychomycosis (<50–65 % nail involvement), with efinaconazole showing the highest rates. Treatments were generally applied daily for 24–48 weeks, with longer treatment and follow-up showing better outcomes.
Conclusion
Topical treatment with amorolfine, ciclopirox, tavaborole, or efinaconazole is appropriate for cases of mild to moderate toenail onychomycosis due to dermatophyte or mixed dermatophyte/Candida infection.
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NewsBot · Jul 16, 2015

Emerging topical onychomycosis therapies - quo vadis?
Elkeeb R, Hui X, Murthy N, Maibach HI.
Expert Opin Emerg Drugs. 2014 Dec;19(4):489-95. doi: 10.1517/14728214.2014.975206. Epub 2014 Nov 17.

INTRODUCTION:
Onychomycosis, a common chronic fungal infection affecting fingernails and toenails, globally may affect 10 - 30% of the population. This chronic disease is difficult to eradicate. The goal of developing a highly effective and safe topical treatment has not yet been reached as it depends on the type of onychomycosis and the variety of invaders.
AREAS COVERED:
Topical drug delivery to the nail is highly desirable in treating nail disorders. However, efficacy of topical therapies is low due to their limited permeability across the nail plate. Advances have especially been made by the development of new therapeutic options including new drug entities, new formulations and reformulations. This overview updates emerging topical treatments for onychomycosis, research progress and future perspectives.
EXPERT OPINION:
Development of novel effective noninvasive topical therapy for treating onychomycosis and other nail diseases such as psoriasis is long overdue. Previously there was a lack of basic knowledge about nail and its barrier properties, but with the recent increased interest in this field both from industry and academia, we hope extensive research will continue in this field to bring about successful and safe treatments for such chronic diseases.
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NewsBot · Jul 29, 2015

Therapies for Onychomycosis
A Systematic Review and Network Meta-analysis of Mycological Cure
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Aditya K. Gupta, MD, PhD, FRCP(C); Deanne Daigle, MSc; Maryse Paquet, PhD
Journal of the American Podiatric Medical Association: July 2015, Vol. 105, No. 4, pp. 357-366.

New therapies for onychomycosis continue to be developed, yet treatments are seldom directly compared in randomized controlled trials. The objective of this study was to compare the rates of mycological cure for oral and topical onychomycosis treatments using network meta-analysis. A systematic review of the literature on onychomycosis treatments published before March 25, 2013, was performed, and data were analyzed using network meta-analysis. Terbinafine, 250 mg, therapy was significantly superior to all treatments except itraconazole, 400 mg, pulse therapy; itraconazole, 200 mg, therapy was significantly superior to fluconazole and the topical treatments; and fluconazole, efinaconazole, ciclopirox, terbinafine nail solution, and amorolfine treatments were significantly superior to only placebo. These results support the superiority of 12-week continuous terbinafine, 250 mg, therapy and itraconazole, 400 mg, pulse therapy (1 week per month for 3 months) while suggesting the equivalence of topical therapies. These results reflect findings from the literature and treatment efficacy observed in clinical practice.
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NewsBot · Feb 22, 2022

A Clinical Study for the Treatment of Onychomycosis Patients Using a Novel ROS Producing Onychomycosis Treatment When Compared Against 5% Amorolfine Topical Lacquer to Reduce the Visible Size of Infected Toenails
M.Ehrensberger et al
Journal of Medical Mycology 18 February 2022, 101256

Background
Onychomycosis affects approximately 5% of the population worldwide without satisfactory treatment options regarding efficacy and safety. The aim of this first in human study was to compare the safety and efficacy of the novel compound Mycosinate® against an approved toenail lacquer containing 5% Amorolfine.

Design
A randomized, single-blinded, controlled parallel group study with allocation concealment was carried out.

Methods
Thirty-eight participants either used the novel compound Mycosinate® or an approved toenail lacquer containing 5% Amorolfine for topical application in their own homes. Outcome measures included a) % change in area of clear visible toenail, b) mycological cure rate and c) safety assessments.

Results
Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine. No statistically significant differences were noted for mycological cure rates. No adverse events, serious adverse events or deaths occurred for either treatment.

Conclusion
Mycosinate® is a promising novel topical onychomycosis treatment with high rates of efficacy and excellent safety profile. Further clinical trials are warranted.
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