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Efinaconazole Topical Solution, 10%

Efficacy in Patients with Onychomycosis and Coexisting Tinea Pedis

Bryan Markinson Division of Podiatric Medicine and Surgery, Leni and Peter W. May Department of Orthopedic Surgery, Mount Sinai School of Medicine, New York, NY.

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Bryan Caldwell Department of Clinical Education and Clinic Operations, College of Podiatric Medicine, Kent State University, Independence, OH.

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Background

We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis.

Methods

We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis.

Results

Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure.

Conclusions

Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

Corresponding author: Bryan Markinson, DPM, Mount Sinai School of Medicine in New York, NY 10029. (E-mail: Bryan.Markinson@mountsinai.org)