Terbinafine Hydrochloride for the Treatment of Otomycosis

NCT07152327 | Not Yet Recruiting

• 1 other identifier: OTO-Terbinafine-2025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 diabetes, frequent use of antibiotic ear drops, or swimming in polluted water. Standard treatments include antifungal ear drops, but relapses are frequent. This study will evaluate the effectiveness of terbinafine hydrochloride cream, an antifungal medication, in treating otomycosis. Terbinafine is known to be active against fungi such as Aspergillus and Candida, which are common causes of ear fungal infections. In this study, patients with otomycosis will have terbinafine hydrochloride cream applied on an ear pack that will be placed in the ear canal and changed every two days for two weeks. The main goal of the study is to find out whether terbinafine hydrochloride is effective in reducing symptoms and eradicating the fungal infection. Patients will be examined clinically and ear swabs will be tested before and after treatment. The study will be conducted at Assiut University Hospital and Assiut General Hospital in Egypt, and about 50 patients are expected to participate.

Conditions

Otomycosis; Fungal Ear Infection

Keywords

Otomycosis; Aspergillus; Candida

Outcome Measures

Primary Outcomes (2)

• Clinical and mycological cure rate of otomycosis after topical terbinafine

  Proportion of participants achieving both: (a) clinical resolution of otomycosis signs and symptoms (itching, otalgia, otorrhea, canal edema/debris) with a normal otoscopic exam, and (b) negative fungal culture from an ear swab. "Cure" is defined as meeting both criteria; otherwise recorded as "no cure."

  14 days (±3) from treatment initiation

• Clinical and mycological cure rate of otomycosis after topical terbinafine

  Proportion of participants achieving both: (a) clinical resolution of otomycosis signs and symptoms (itching, otalgia, otorrhea, canal edema/debris) with a normal otoscopic exam, and (b) negative fungal culture from an ear swab. "Cure" is defined as meeting both criteria; otherwise recorded as "no cure

  14 days (±3) from treatment initiation

Study Arms (1)

Terbinafine Hydrochloride Cream

EXPERIMENTAL

Participants diagnosed with otomycosis will receive topical terbinafine hydrochloride cream applied on an ear pack. The pack will be inserted into the external auditory canal and changed every 2 days for a total duration of 2 weeks.

Drug: Terbinafine Hydrochloride Cream

Interventions

Terbinafine Hydrochloride Cream DRUG

Topical antifungal treatment. Terbinafine hydrochloride 1% cream will be applied on an ear pack, inserted into the external auditory canal, and changed every 2 days. Treatment continues for 14 days.

Terbinafine Hydrochloride Cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

  PMID: 29786478 BACKGROUND

• Hentzer E. Histologic studies of the normal mucosa in the middle ear, mastoid cavities and Eustachian tube. Ann Otol Rhinol Laryngol. 1970 Aug;79(4):825-33. doi: 10.1177/000348947007900414. No abstract available.

  PMID: 5526992 BACKGROUND

MeSH Terms

Conditions

Otomycosis; Torulopsis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Doaa samy abdellatif, MBBCh

CONTACT

01099427096; nemo.memo19.nm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label design; neither participants nor investigators are blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident , ENT

Model Details: All enrolled participants will receive terbinafine hydrochloride cream applied on an ear pack. There is no comparator arm in this study.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09