Prunus salicina extract drops with or without nanoparticles vs clotrimazole for outer ear fungus
Official title: Comparative Efficacy of Nanoparticle-Based Prunus Salicina Methanolic Extract Drops Versus Standard Antifungal Therapy for Otomycosis: A Randomized Controlled Trial
Run by Deraya University · NCT07867223 · Data updated 2026-11-12
This trial tests whether Japanese plum extract drops, delivered as standard or chitosan nanoparticle drops, can more effectively treat otomycosis than 1% clotrimazole drops.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 80 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Deraya University Academic / other |
| Locations | 1 site (Minya) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07867223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 16–80 with a confirmed diagnosis of otomycosis and no exclusions such as diabetes, pregnancy, or recent systemic antifungal use.
✕Probably not a fit
Patients with non-fungal ear infections, bacterial otitis, or contraindications to topical agents may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, controlled trial compares three topical treatments for otomycosis over seven days, with a follow-up at one month. Participants are 16 to 80 years old and have confirmed fungal infection of the external ear canal. The study uses Prunus salicina methanolic extract in two formulations—standard drops and nanoparticle-based drops—against the standard antifungal clotrimazole drops. The primary goal is to determine if the plum extract formulations yield higher mycological and clinical cure rates. The trial assumes an absolute treatment effect of 19 percentage points for planning purposes.
Why it matters
Potential benefit: If successful, patients may experience faster or higher rates of fungal clearance and symptom relief with a natural-derived, potentially longer-acting topical treatment.
How similar studies have gone: Prior work suggests nanoparticle delivery can improve drug retention, but efficacy data for Prunus salicina in otomycosis is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 16-80 years. * Confirmed clinical diagnosis of otomycosis via otoscopic examination (visible fungal elements such as hyphae, spores, curdy precipitates). * Willing and able to provide informed consent. Exclusion Criteria: * Otitis media, malignant otitis externa, chronic mucosal ear discharge. * Previous ear surgery or anatomical anomalies. * Systemic antifungal or corticosteroid therapy within two weeks prior. * Pregnancy or lactation. * Concurrent bacterial infection. * Diabetes mellitus.
Where it's running
-
Minia University Hospital
Minya, Egypt Recruiting
Study contacts
- Study coordinator: Aliaa Hussien
- Email: aliaagamal2622@gmail.com
- Phone: 01003041632
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.