An interventional study of Group A and Group B in Otomycosis and Antifungal Agents, sponsored by Deraya University. Recruiting at 1 site in Egypt. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Deraya University · Not applicable, Interventional, and Treatment
This randomized controlled superiority trial evaluates the anti-otomycotic efficacy of Prunus salicina methanolic extract in two formulations (standard drops and chitosan nanoparticle-based drops) compared to standard 1% clotrimazole drops in patients diagnosed with otomycosis.
Otomycosis is a superficial fungal infection of the external auditory canal, predominantly caused by Aspergillus and Candida species. Topical antifungal agents, particularly 1% clotrimazole, are the mainstay of treatment; however, their effectiveness is suboptimal due to antifungal resistance, poor adherence, and short retention time of liquid formulations. Prunus salicina (Japanese Plum) fruits contain over 40 phenolic compounds with significant antifungal efficacy. Nanoparticle-based drug delivery systems have shown potential in enhancing drug retention and sustained release. This study compares three treatment arms over a 7-day treatment period with follow-up at 1 month. The primary hypothesis is that Prunus salicina formulations will demonstrate superiority over standard clotrimazole in achieving mycological clinical cure. An anticipated absolute treatment effect of 19 percentage points was used for study planning.
Deraya University is the lead sponsor of 50 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clotrimazole 1% ear drops: Aqueous solution of 200 mg clotrimazole in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal as per standard clinical practice for 7 days.
Drug: Group A
Prunus salicina Extract Drops: Aqueous solution (1:100 w/v) of Prunus salicina methanolic extract in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal for 7 days.
Drug: Group B
Chitosan Nanoparticle Prunus salicina Extract Drops: Chitosan nanoparticles loaded with Prunus salicina extract (Ch-PS-NPs) prepared by ionotropic gelation. Drops applied to affected ear canal for 7 days.
Drug: Group C
Clotrimazole 1% ear drops: Aqueous solution of 200 mg clotrimazole in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal as per standard clinical practice for 7 days.
Prunus salicina Extract Drops: Aqueous solution (1:100 w/v) of Prunus salicina methanolic extract in sterile saline (9 mg/mL NaCl). Drops applied to affected ear canal for 7 days.
Chitosan Nanoparticle Prunus salicina Extract Drops: Chitosan nanoparticles loaded with Prunus salicina extract (Ch-PS-NPs) prepared by ionotropic gelation. Drops applied to affected ear canal for 7 days.
Mycological Clinical Cure Rate at Day 14
Proportion of participants achieving complete resolution of clinical signs and symptoms of otomycosis (pruritus, otalgia, otorrhea, and hearing impairment) AND a negative fungal culture. The primary analysis will test for superiority of each Prunus salicina formulation over clotrimazole. The anticipated absolute treatment effect used for study planning was 19 percentage points.
Time frame: Day 14 (end of treatment)
Treatment Response Classification at Day 14
Categorical classification of treatment response based on reduction in total symptoms and sign scores combined with culture result. Good Response: ≥75% reduction in total symptom/sign scores with negative fungal culture. Moderate Response: 50-74% reduction with partial symptom relief or pending culture result. Poor Response: \<50% improvement or persistent/worsening symptoms and positive fungal culture.
Time frame: Day 14
Symptom Severity Score
Total symptom score measured using a standardized 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for each symptom (pruritus, otalgia, otorrhea, hearing impairment, tinnitus, fullness). Summed to a total score.
Time frame: Days 0, 3, 5, 7, and 14
Sign Severity Score
Total sign score objectively assessed via otoendoscopic examination of canal erythema, edema, discharge, and tympanic membrane congestion. Each sign graded on a 0-3 scale (0 = absent, 3 = severe). Summed to a total score.
Time frame: Days 0, 3, 5, 7, and 14
Microbiological Clearance
Fungal and bacterial culture results from ear discharge collected at baseline and end of treatment. Mycological cure defined as a negative fungal culture.
Time frame: Day 0 and Day 14
Recurrence Rate
Proportion of participants with reappearance of clinical symptoms and/or a positive fungal culture after initial clinical cure, assessed via clinical examination and fungal culture.
Time frame: 2 weeks post treatment
Number of Participants with Adverse Events
Incidence of treatment-emergent adverse events, including irritant dermatitis, headache, otalgia, and drug residue in the ear canal, assessed by the investigator at each visit.
Time frame: Day 0 - Day 28
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Otomycosis
Deraya University