FPIN's Help Desk Answers
Topical Antifungals for Treatment of Onychomycosis
Am Fam Physician. 2016 Nov 1;94(9):734.
What is the rate of resolution of onychomycosis treated with topical antifungal agents?
Topical antifungal agents are effective in treating onychomycosis, with a number needed to treat (NNT) of 7 to 17. (Strength of Recommendation: A, based on consistent findings from good-quality randomized controlled trials.) Efinaconazole 10% topical solution achieved complete cure rates of 15% to 18% vs. 3.3% to 5.5% for vehicle (NNT = 7 to 10). Tavaborole 5% topical solution achieved complete cure rates of 6.5% to 9.1% vs. 0.5% to 1.5% for vehicle (NNT = 13 to 17). Ciclopirox 8% nail lacquer achieved a complete cure rate of 7% compared with 1% for vehicle (NNT = 17). Each medication must be used daily for 48 weeks.
A 2013 review of two randomized, double-blind, vehicle-controlled, parallel-group, multicenter trials (n = 870 and 785) evaluated efinaconazole 10% topical solution vs. vehicle with no efinaconazole for complete cure of distal subungual onychomycosis.1 Patients 18 to 70 years of age received efinaconazole or vehicle, which they applied once daily for 48 weeks followed by four weeks of treatment-free follow-up. Effectiveness and safety were assessed at 12-week intervals and at a final visit at 52 weeks. At the 52-week visit, complete cure was significantly greater for patients who used efinaconazole (study 1: 18% vs. 3.3%; study 2: 15% vs. 5.5%; P < .001). Adverse events included local site reactions (2%) and were clinically similar to those associated with vehicle.
A 2015 review of two randomized, double-blind, vehicle-controlled, parallel-group, multicenter trials (n = 594 and 604) evaluated tavaborole 5% topical solution vs. vehicle with no tavaborole for complete cure of distal subungual onychomycosis.2 Patients 18 years and older were randomized (2:1) to receive tavaborole or vehicle once daily for 48 weeks. Effectiveness and safety were assessed at baseline, week 2, week 6, and every six weeks thereafter until week 48, with final
1. Elewski BE, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2013;68(4):600–608.
2. Elewski BE, et al. Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis. J Am Acad Dermatol. 2015;73(1):62–69.
3. Gupta AK, et al. Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. J Am Podiatr Med Assoc. 2000;90(10):495–501.
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