SLR - June 2016 - Sapan H. Amin

Efinaconazole Topical Solution, 10 Percent, for the Treatment of Mild and Moderate Toenail Onychomycosis

Reference: Rodriquez DA. Efinaconazole Topical Solution, 10 Percent, for the Treatment of Mild and Moderate Toenail Onychomycosis. J Clin Aesthet Dermatol. 2015 Jun; 8(6): 24-9.

Scientific Literature Review

Reviewed By: Sapan H. Amin, DPM
Residency Program: Wyckoff Heights Medical Center

Podiatric Relevance: Onychomycosis is regularly seen in podiatric clinics. The amount of nail involvement by onychomycosis can be used to differentiate the degree of severity. Mild onychomycosis such as 25 percent or less of the toenail, 25 to 74 percent for moderate, and greater than 75 percent for severe, are used to classify the extent of the infection. This study attempted to evaluate the effectiveness of efinaconazole topical solution, 10 percent for treating onychomycosis in regards to efficacy, safety, and tolerability.

Methods: The study was a randomized, double blind, vehicle controlled study using two centers to treat onychomycosis. One thousand, six hundred and fifty-five patients with either mild or moderate onychomycosis were assessed in this study. Efficacy and safely were monitored for patients over a 48-week time period. Complete cure rate of patients was the primary objective, which was assessed at Week 52. The study defined complete cure rate as negative potassium hydroxide exam and fungal culture with 0 percent clinical involvement of the toenail. Secondary efficacy endpoints included mycologic cure and treatment success (less than or equal to 10 percent involvement of affected nail).  

Complete cure was achieved by 25.8 percent of patients with mild infection and 15.9 percent of patients with moderate infection. The vehicle study groups showed complete cure in 11.3 and 2.7 percent of patients with mild and moderate infections respectively. Mycologic cure rates using efinaconazole for mild infection was 58.2 percent and for moderate infection it was 55.5 percent. In the vehicle study groups there was only a 25 and 14.1 percent cure rate for mild and moderate infections respectively. Using efinaconazole, treatment success at week 52 was 65.7 percent and 40.7 percent for mild and moderate infection respectively. Treatment success using the vehicle was 37.8 and 12.1 percent for mild and moderate infection respectively. Efinaconazole and the vehicle study had similar adverse events which were reactions at the local site.

Conclusions: Efinaconazole topical solution, 10 percent can be useful for treatment in mild to moderate onychomycosis. Complete cure, mycologic cure rate, and treatment success, all showed significant improvement for mild and moderate infection when compared to the control group. The mild infection group treated with efinaconazole showed slightly better results when compared to the moderate infection group. Depending on the age and if the patient has multiple comorbidities, the patient may not be able to tolerate oral antifungal medication treatment. Often the prescribing doctor can be restricted to only topical treatments for onychomycosis and this study shows that efinaconazole can be a viable option.

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