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To a layperson, a funky toenail means fungus infection, and dermatophytic fungi do cause many funky nails. Patients seek treatment for relief of symptoms, but especially to improve appearance. To date, topical treatments for distal subungual onychomycosis have generally failed to help.
Two identical, multicenter, randomized, double-blind studies in 1655 patients (age range, 18–70 years) were conducted and overseen by a small army of primary investigators at 118 sites to assess the effectiveness of topical efinaconazole for treatment of mild-to-moderate (20%-to-50% involvement), distal lateral subungual onychomycosis. Infection was proved by potassium hydroxide test and microbiologic culture. Inclusion criteria included fungus infection of at least one great toenail, target toenail unaffected length of at least 3 mm, and thickness less than 3 mm.
Patients were randomly assigned to apply efinaconazole 10% solution or vehicle (3:1 randomization ratio) once daily for 48 weeks without debridement, followed by a 4-week treatment-free interval. The primary endpoint was cure at 52 weeks, as assessed by clinical observation, potassium hydroxide testing, and fungal culture. Complete cure occurred more often in efinaconazole-treated patients in both studies (18% vs. 3% and 15% vs. 6%). Percentages of patients with mycological cures were 55% and 53%. All treatment-related adverse events were local site reactions.
Elewski BE et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies. J Am Acad Dermatol 2013 Apr; 68:600. (http://dx.doi.org/10.1016/j.jaad.2012.10.013)
Comment
We need an effective topical treatment for distal subungual onychomycosis, and this may be it. The results of the two studies were remarkably similar, proving both that the studies were valid and that the treatment worked. Half of the subjects achieved mycological cure. Clinical cure might have reached that high proportion, too, if the observation period had been extended well beyond 1 year. The patients were healthy, so efficacy in immunosuppressed patients is unknown. Children were not included, but onychomycosis in children is uncommon. Other excluded groups were those with severe distal subungual onychomycosis, superficial white onychomycosis, proximal subungual onychomycosis, and onychomycosis due to Candida species and mold, and patients with coexisting severe “moccasin tinea pedis.”