Status:

NOT_YET_RECRUITING

Terbinafine Hydrochloride for the Treatment of Otomycosis

Lead Sponsor:

Assiut University

Conditions:

Otomycosis

Fungal Ear Infection

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

Otomycosis is a fungal infection of the ear that often causes itching, pain, ear discharge, and hearing problems. It is more common in hot and humid climates and in people with risk factors such as di...

Detailed Description

Otomycosis is a common fungal infection of the external auditory canal. It is often associated with itching, ear blockage, tinnitus, pain, and hearing loss. Diagnosis is made clinically and confirmed ...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years (male or female).
  • Clinical diagnosis of otomycosis (presence of itching, ear discharge, ear canal debris, or fungal mass on otoscopic exam).
  • Confirmation of fungal infection by direct microscopy (KOH preparation) and/or culture.
  • Willingness to comply with study procedures and follow-up visits.
  • Provided written informed consent.

Exclusion

  • Age \< 18 years.
  • Bacterial otitis externa, mixed bacterial-fungal infection, or chronic suppurative otitis media.
  • History of ear surgery or tympanic membrane perforation.
  • Use of systemic or topical antifungal agents within the last 2 weeks.
  • Known hypersensitivity or allergy to terbinafine or excipients of the study drug.
  • Immunocompromised patients (e.g., HIV/AIDS, chemotherapy, uncontrolled diabetes mellitus).
  • Pregnant or breastfeeding women.
  • Patients unable or unwilling to provide informed consent or adhere to treatment protocol.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07152327

Start Date

October 1 2025

End Date

December 1 2026

Last Update

October 1 2025

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