A Retrospective Study Comparing K101 Nail Solution as a Monotherapy and in Combination with Oral Terbinafine or Itraconazole for the Treatment of Toenail Onychomycosis

Abstract

Background: Onychomycosis is a difficult-to-treat fungal infection of the nails. The efficacy of monotherapy is not ideal, and combination therapies provide an alternative that may increase treatment efficacy. Method: A retrospective analysis of data from 91 patients was undertaken. Treatment for toenail onychomycosis occurred between 2014 and 2016 and consisted of combination therapy with oral terbinafine (250 mg/day for 12 weeks) or itraconazole (3 pulses, 400 mg/day for 7 days) + K101 nail solution daily, or K101 nail solution monotherapy. Efficacy outcomes at 12 and 15 months were analyzed. Results: At 12 months, the clinical cure rate for combination of terbinafine + K101 solution was significantly higher than that for K101 monotherapy (p = 0.008). Patients receiving this combination also showed significant improvement in percent of affected nail at 3 months (p = 0.029), while patients receiving itraconazole + K101 solution demonstrated improvement in percent of affected nail at 6 months (p = 0.037). At 15 months, there was no significant difference between treatments for complete, clinical, and mycological cure. Conclusion: Combination therapy with oral terbinafine or itraconazole and K101 nail solution results in clearance of infected nail earlier than that with topical K101 alone. These combinations may encourage compliance and be effective for patients with moderate onychomycosis.