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A multicenter, randomized, parallel‐group, double‐blind, vehicle‐controlled and open label vs amorolfine 5% study, to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis

Mycoses Nov 14, 2021

Blume-Peytavi U, Tosti A, Falqués M, et al. - Researchers examined whether terbinafine 10% nail lacquer is efficacious and safe for treating distal lateral subungual onychomycosis (DLSO).

  • Randomization of patients with mild-to-moderate DLSO was (3:3:1) done to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) provided once daily for 4 weeks and then once weekly for 44 weeks, or open-label topical amorolfine 5% (n = 137) for 48 weeks, with a 12-week follow-up period.

  • Outcomes support the effectiveness of terbinafine 10% nail lacquer in improving both clinical and mycological criteria in mild-to-moderate onychomycosis when compared with vehicle.

  • When compared with the currently available topical agent, amorolfine 5%, terbinafine 10% nail lacquer may yield some benefits.

  • Findings demonstrate good tolerability as well as safety of the treatment.

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