A Randomised Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Two-Dose Topical Terbinafine and Betamethasone Gel for the Treatment of Yeast (Malassezia pachydermatis) Otitis Externa in Dogs.

Two-dose terbinafine/betamethasone otic gel significantly outperforms placebo for canine Malassezia otitis externa.

This randomized, placebo-controlled study evaluated the efficacy and safety of a two-dose otic gel containing 1% terbinafine and 0.1% betamethasone acetate (TBG) for the treatment of yeast-predominant otitis externa (OE) in dogs. A total of 239 privately owned dogs were enrolled based on an otitis index score (OTIS3) ≥ 6 and cytological confirmation of Malassezia pachydermatis predominance with limited bacterial involvement. Dogs received TBG or placebo (saline) on Day 0 and Day 7, with follow-up assessments at Days 7, 14, 28, and 45. Clinical success, defined as an OTIS3 score ≤ 3 at Day 45, was achieved in 62.9% of TBG-treated dogs compared to 20.0% in the placebo group (p < 0.0001). Veterinary surgeons and owners rated the treatment response as 'excellent' or 'good' in 61.9% and 71.1% of cases, respectively. Cytological yeast counts were also significantly reduced in the TBG group. Safety assessments, including hematology, clinical chemistry, urinalysis, and adverse event monitoring, confirmed an acceptable safety profile. Notably, this antibiotic-free formulation aligns with antimicrobial stewardship principles by avoiding unnecessary antibiotic use in cases where yeast overgrowth is the primary pathogen. These findings support TBG as an effective and safe treatment option for Malassezia-associated canine otitis externa requiring only two applications.

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