From the Guidelines
Ciclopirox 8% nail lacquer is a suitable treatment option for mild to moderate onychomycosis, particularly when oral antifungals are contraindicated, with a recommended treatment duration of up to 48 weeks. The standard regimen involves applying the lacquer daily to affected nails after cleaning with alcohol, allowing it to dry for 30 seconds, and not washing it off for at least 8 hours [ 1, 2 ]. According to the British Association of Dermatologists' guidelines, ciclopirox has a strength of recommendation of C and is useful for superficial and distal onychomycosis [ 1 ]. The mechanism of action of ciclopirox involves inhibiting metal-dependent enzymatic processes, including nutrient uptake, cellular energy production, and degradation of toxic intracellular peroxide [ 2 ].
Key Points to Consider
- Ciclopirox 8% nail lacquer is effective against T. rubrum, S. brevicaulis and Candida species [ 2 ]
- The recommended treatment duration is up to 24 weeks on the fingernails and up to 48 weeks on the toenails [ 2 ]
- Cure rates with ciclopirox are modest, approximately 5-12% complete cure, and it works best for distal subungual onychomycosis affecting less than 50% of the nail [ 2 ]
- Common side-effects include periungual and nail fold erythema [ 1, 2 ]
Treatment Considerations
- Complete nail regrowth may take 6-12 months for fingernails and 12-18 months for toenails
- For more severe infections, combination therapy with oral antifungals or nail debridement may be necessary to improve outcomes
- Ciclopirox is a suitable alternative when oral antifungals are contraindicated, such as in patients with heart failure, hepatotoxicity, or renal impairment [ 1 ]
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 Ciclopirox 8% is appropriate for the treatment of onychomycosis in certain cases, specifically:
- Mild to moderate onychomycosis
- Immunocompetent patients
- Fingernails and toenails without lunula involvement
- Due to Trichophyton rubrum As part of a comprehensive management program, including removal of the unattached, infected nails as frequently as monthly, by a health care professional 3
From the Research
Efficacy of Ciclopirox 8% for Onychomycosis Treatment
- Ciclopirox 8% nail lacquer has been approved by the US Food and Drug Administration for the treatment of onychomycosis, with studies showing a mycologic cure rate of 34% compared to 10% for the placebo 4.
- The combined results of ten studies conducted worldwide show a meta-analytic mean mycologic cure rate of 52.6% +/- 4.2% 4.
- Ciclopirox nail lacquer 8% topical solution has been demonstrated to be significantly more effective than placebo in the treatment of onychomycosis caused by Trichophyton rubrum, with mycologic cure rates ranging from 29% to 36% in US studies 5.
- Non-US studies have shown mycologic cure rates ranging from 46.7% to 85.7%, with ciclopirox nail lacquer demonstrating a broad spectrum of activity against Candida species and some nondermatophytes 5.
Safety and Combination Therapy
- Ciclopirox nail lacquer is considered extremely safe, with most treatment-emergent adverse events being mild and transient, and localized to the site of application 4, 5.
- Combination therapy of oral terbinafine and ciclopirox nail lacquer has been shown to be more effective than terbinafine alone, with mycological cure rates of 88.2% compared to 64.7% for terbinafine alone 6.
- A randomized, double-blind, amorolfine-controlled study found that ciclopirox 8% HPCH nail lacquer was statistically superior to amorolfine 5% in the treatment of mild-to-moderate toenail onychomycosis, with a treatment success rate of 58.3% compared to 26.7% for amorolfine 7.
Comparison with Other Treatments
- Amorolfine 5% and ciclopirox 8% nail lacquers are commonly used in topical treatment of onychomycosis, with both formulations having a broad antifungal activity 8.
- The use of antifungal nail lacquers in combination with oral agents, such as terbinafine and itraconazole, improves efficacy of antifungal therapy 8.