What are the topical treatments for onychomycosis (fungal nail infection)?

From the Guidelines

For fungal nail infections, I recommend using topical antifungal medications such as amorolfine 5% lacquer, which has been shown to be effective in around 50% of cases of distal fingernail and toenail onychomycosis 1. When treating fungal nail infections, it is essential to choose the most effective topical antifungal medication.

• Amorolfine 5% lacquer is a broad-spectrum antifungal that inhibits the delta 14 reductase and delta 8 and delta 7 isomerase enzymes in the ergosterol biosynthetic pathway, making it fungicidal against C. albicans and T. mentagrophytes 1.
• Apply amorolfine 5% lacquer to the affected nail once or twice weekly for 6–12 months, after removal of as much of the diseased areas of the nail as possible by gentle filing.
• It is crucial to note that clinical improvement obtained with amorolfine and other topical antifungals may not be synonymous with mycological cure, which has invariably lower rates, often by 30% 1.
• In comparison to ciclopirox 8% nail lacquer, amorolfine 5% lacquer has been found to have higher cure rates, although there are no head-to-head trials comparing the two medications 1.
• To improve treatment outcomes, keep nails trimmed, dry, and avoid sharing nail tools to prevent reinfection.
• Be aware that topical treatments are most effective for mild to moderate infections affecting less than 50% of the nail, with limited penetration to the nail bed, and that oral antifungals may be necessary for severe infections.

From the FDA Drug Label

Ciclopirox Topical Solution, 8%, (Nail Lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum

• Indication: Ciclopirox topical solution is indicated for the treatment of mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.
• Key points:
  • The treatment should be part of a comprehensive management program.
  • The program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional.
  • The solution should be used only under medical supervision.
  • The effectiveness and safety of the solution in certain populations, such as pregnant or nursing women, have not been studied.
• Efficacy: Statistical significance was demonstrated in one of two studies for the endpoint "complete cure" (clear nail and negative mycology), and in two studies for the endpoint "almost clear" (≤ 10% nail involvement and negative mycology) at the end of study 2

From the Research

Topical Treatments for Fungal Nails

• Ciclopirox nail lacquer 8% is a topical solution used to treat onychomycosis, with studies showing its efficacy in treating mild to moderate toe onychomycosis caused by dermatophytes 3.
• Amorolfine 5% and ciclopirox 8% nail lacquers are commonly used in the topical treatment of onychomycosis, and can be used alone or in combination with oral antifungal agents 4.
• Ciclopirox has a broad spectrum of antimicrobial activity, including against dermatophytes, yeast, and nondermatophyte molds, and has demonstrated fungicidal activity with no identified resistance to date 5.

Combination Therapy

• Combining oral and topical antifungal drugs is associated with higher success rates in treating onychomycosis 6.
• The combination of terbinafine with amorolfine tends to be more effective than terbinafine with ciclopirox, with additive or synergistic effects observed in most combinations 6.
• The use of topical therapies, such as ciclopirox and amorolfine nail lacquers, in combination with oral antifungal agents may further improve efficacy rates in certain clinical presentations 7.

Safety and Efficacy

• Ciclopirox nail lacquer is considered extremely safe, with most treatment-emergent adverse effects being transient and localized to the site of action 3.
• Topical agents, such as ciclopirox and amorolfine, have a favorable adverse events profile compared to oral antifungal agents 7.
• The efficacy of topical treatments for onychomycosis can be improved by combining them with oral antifungal agents, particularly in cases of severe onychomycosis 7.