From the Guidelines
Ciclopirox topical solution has a mycological cure rate of 34% and a clinical cure rate of 8% after up to 48 weeks of treatment for toenail fungus, but specific cure rates at 3 and 6 months are not provided in the available evidence. The available study 1 shows that ciclopirox lacquer once daily is more effective than placebo in the treatment of toenail onychomycosis. Some key points to consider when using ciclopirox topical solution for toenail fungus include:
- The medication should be applied daily to clean, dry nails for up to 48 weeks.
- Monthly removal of unattached infected nail material is recommended.
- Patients should be aware that toenail fungus is notoriously difficult to treat topically due to limited penetration through the nail plate.
- Oral antifungals often have higher cure rates, but ciclopirox offers a safer alternative for patients who cannot take oral medications due to side effect concerns or drug interactions.
- Patience is required as visible improvement may take several months, and relapse is common even after successful treatment. The cure rates of ciclopirox topical solution at 3 and 6 months are not explicitly stated in the study 1, but it is known that the treatment duration can be up to 48 weeks on the toenails. Key benefits of using ciclopirox topical solution include:
- Broad-spectrum antifungal activity against T. rubrum, S. brevicaulis and Candida species.
- Inhibition of metal-dependent enzymatic processes including nutrient uptake, cellular energy production and degradation of toxic intracellular peroxide.
- A safer alternative for patients who cannot take oral medications due to side effect concerns or drug interactions.
From the FDA Drug Label
The results of use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312Study 313 ActiveVehicleActiveVehicle
- Clear nail and negative mycology † ≤ 10% nail involvement and negative mycology ‡ Negative KOH and negative culture Complete Cure*6/110 (5.5%)1/109 (0.9%)10/118 (8.5%)0/117 (0%) Almost Clear†7/107 (6.5%)1/108 (0.9%)14/116 (12%)1/115 (0. 9%) Negative Mycology Alone‡30/105 (29%)12/106 (11%)41/115 (36%)10/114 (9%)
The cure rate of ciclopirox topical for toenail fungus at 6 months (Week 48) is:
- Complete Cure: 5.5% (6/110) in Study 312 and 8.5% (10/118) in Study 313
- Almost Clear: 6.5% (7/107) in Study 312 and 12% (14/116) in Study 313 There is no information about the cure rate at 3 months in the provided drug label 2.
From the Research
Cure Rate of Ciclopirox Topical for Toenail Fungus
- The cure rate of ciclopirox topical for toenail fungus is reported in several studies, with varying results:
- A study published in the Journal of the American Podiatric Medical Association 3 reported a 34% mycologic cure rate at the end of the 48-week treatment period.
- Another study published in the Journal of the American Academy of Dermatology 4 reported mycologic cure rates of 29% and 36% at the end of the 48-week treatment period in two separate studies.
- A Cochrane review 5 reported that ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio 9.29,95% confidence interval 1.72 to 50.14) and mycological cure (risk ratio 3.15,95% confidence interval 1.93 to 5.12) compared to vehicle.
Timeframe for Cure Rate
- The studies do not provide specific cure rates at 3 and 6 months, but rather report outcomes at the end of the treatment period (usually 48 weeks).
- However, a study published in the American Journal of Clinical Dermatology 6 mentions that treatments were generally applied daily for 24-48 weeks, with longer treatment and follow-up showing better outcomes.
Safety and Efficacy
- Ciclopirox topical is considered extremely safe, with mild, transient irritation at the site of application reported as the most common adverse event 3, 4.
- The Cochrane review 5 reports that ciclopirox 8% lacquer may lead to increased adverse events, commonly application reactions, rashes, and nail alteration, but the 95% confidence interval indicates that ciclopirox lacquer may actually make little or no difference.