Terbinafine Hydrochloride for the Treatment of Otomycosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years (male or female).
Disqualifiers
Age < 18 years.
Trial design
Design model
Single group
Treatments tested in this trial
Terbinafine Hydrochloride Cream
DrugTopical 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Terbinafine Hydrochloride CreamExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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."
Time frame
14 days (±3) from treatment initiation2
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
Time frame
14 days (±3) from treatment initiationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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