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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