Anti-infective methods, compositions, and devices

A method of treating onychomycosis comprising applying a pharmaceutically acceptable efinaconazole formulation once a day for a treatment period of at least 36 weeks to the treatment area of an onychomycosis patient (a) without debriding the nail or nail-associated tissue in the treatment area initially or during the treatment period, (b) without removing the formulation from the treatment area during the treatment period, and (c) without occluding the treatment area;

• wherein the efinaconazole formulation comprises 10% w/w efinaconazole, water, cyclomethicone, diisopropyl adipate, alcohol, C12-15 alkyl lactate, butylated hydroxytoluene, citric acid anhydrous, and disodium edetate,
• wherein the amounts of butylated hydroxytoluene and disodium edetate are sufficient to ensure the formulation is (i) colorless upon initial manufacturing of the formulation and (ii) colorless or pale yellow after storage for three weeks at a temperature of about 40° C.,
• wherein the average amount of efinaconazole delivered to each cm2 of the treatment area is about 0.15 mg/cm2 to about 0.45 mg/cm2,
• and wherein applying the formulation results in a mean plasma Cmax in a population of at least 15 adult onychomycosis patients after 28 days of once daily treatment that is less than 0.8 ng/mL.