Otomycosis
Conditions
Interventions
Control group:Treatment with placebo
Experimental group:Treatment with voriconazole ear drops
Sponsors
Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =18 years. 2. Patients diagnosed with fungal infection of the external auditory canal in one or both ears within 1 week. 3. Patients present with symptoms of fungal otitis externa (e.g., ear itching, ear pain, ear fullness, hearing loss, etc.). 4. Presence of white, gray, yellow, or smoky-gray fungal plaques in the external auditory canal upon examination, with a positive fungal smear test of ear canal secretions. 5. Agreement to take measures to avoid water entering the ear canal during the study period (e.g., refraining from swimming, wearing a shower cap to cover both ears during bathing, etc.). 6. Participants must fully understand the trial requirements and voluntarily provide written informed consent before the trial. 7. Women of childbearing potential (including partners of male participants) must have no pregnancy plans from the screening period until 28 days after the last dose and must voluntarily adopt effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Patients unable to undergo otoscopic examination. 2. Tympanic membrane perforation (including tympanostomy tube placement). 3. Bacterial otitis externa. 4. History of malignant tumors in the external auditory canal or current radiation/chemotherapy for cancer. 5. Use of systemic or topical antifungal medications or any drugs that may interfere with the study evaluation within 1 week prior to screening. 6. Known or suspected allergy to antifungal agents or any excipients of the investigational product. 7. Participation in other clinical trials within 3 months prior to screening. 8. Pregnant or lactating women. 9. Individuals deemed ineligible for the study by the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fungal clearance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement;Degree of granulation improvement; | — |
Countries
China
Contacts
Public ContactWei Li
Third Xiangya Hospital of Central South University
Outcome results
None listed