Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis

NCT07867223 | Recruiting

• 1 other identifier: PS-OTOMYCOSIS-2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otomycosis; Antifungal Agents

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 14

Secondary Outcomes (5)

• Symptom Severity Score

  Days 0, 3, 5, 7, and 14

• Sign Severity Score

  Days 0, 3, 5, 7, and 14

• Microbiological Clearance

  Day 0 and Day 14

• Recurrence Rate

  2 weeks post treatment

• Number of Participants with Adverse Events

  Day 0 - Day 28

Study Arms (3)

Group A: Clotrimazole 1%

ACTIVE COMPARATOR

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

Group B: Prunus salicina Extract Drops

EXPERIMENTAL

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

Group C: Prunus salicina Nanoparticle Drops

EXPERIMENTAL

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

Interventions

Group A DRUG

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.

Group A: Clotrimazole 1%

Group B DRUG

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.

Group B: Prunus salicina Extract Drops

Group C DRUG

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.

Group C: Prunus salicina Nanoparticle Drops

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Minia University Hospital

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Otomycosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aliaa Hussien

CONTACT

01003041632; aliaagamal2622@gmail.com

Aliaa Hussein

CONTACT

01003041632

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, active-controlled, three-arm superiority trial

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: July 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)