Eradicating Otomycosis with Terbinafine Solution: Basic and Clinical Investigation.

Area of Science:

• Otolaryngology
• Mycology
• Pharmacology

Background:

• Otomycosis presents clinical challenges due to limited topical antifungal efficacy and potential inner ear toxicity.
• Existing treatments for otomycosis often lack effectiveness or pose risks to auditory and vestibular functions.

Purpose of the Study:

• To evaluate terbinafine solution as a potential treatment for intractable otomycosis in humans.
• To assess the ototoxicity of terbinafine in animal models.

Main Methods:

• Guinea pigs received topical terbinafine (10 and 25 mg/mL) applied to the round window membrane, followed by inner ear function tests and morphological analysis.
• Twenty human patients with otomycosis were treated with 0.4 mg of terbinafine solution.

Main Results:

• Terbinafine showed no inner ear toxicity in guinea pigs at dosages up to 2.5 mg, confirmed by physiological and morphological assessments.
• All 20 patients achieved otomycosis subsidence within one week of treatment with 0.4 mg terbinafine, with no adverse effects or recurrence after one year.

Conclusions:

• Terbinafine solution demonstrates a low potential for inner ear toxicity, even at higher doses in animal models.
• Topical terbinafine at 0.4 mg is a promising and safe treatment option for human otomycosis.