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

Mycoses Dec 09, 2021

Blume-Peytavi U, Tosti A, Falqués M, et al. - Terbinafine 10% nail lacquer was examined for its safety and efficacy in distal-lateral subungual onychomycosis (DLSO).

  • Researchers randomized patients with mild-to-moderate DLSO (3:3:1) to receive double-blind topical terbinafine 10% (n = 406) or its vehicle (n = 410) administered 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.

  • At Week 60, complete cure rates of 5.67%, 2.20% and 2.92% were recorded in the terbinafine, vehicle and amorolfine groups, respectively.

  • Overall findings suggest that mild-to-moderate onychomycosis can be effectively treated using terbinafine 10% nail lacquer improving both clinical and mycological criteria compared with vehicle.

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

  • Treatment was well-tolerated and safe.

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