OtomycosisNCT07867223
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
A study testing Group A, Group B and Group C in people with Otomycosis and Antifungal Agents, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Otomycosis, Antifungal Agents
- What is being tested?
- Group A, Group B and Group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aliaa Hussein contact
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya
Mostafa Nasr Zayed, 01007905656 ext. +20
About this study
Official title: Comparative Efficacy of Nanoparticle-Based Prunus Salicina Methanolic Extract Drops Versus Standard Antifungal Therapy for Otomycosis: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Otomycosis, Antifungal Agents
- Being tested
- Group A, Group B, Group C
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADrug
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 BDrug
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 CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 14
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Jul 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, active-controlled, three-arm superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867223
- Sponsor's protocol ID
- PS-OTOMYCOSIS-2025
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Nanoparticle-Based Prunus Salicina Methanolic Extract Drops Versus Standard Antifungal Therapy for Otomycosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867223
- Acronym / sponsor ID
- PS-OTOMYCOSIS-2025
- Conditions
- Otomycosis, Antifungal Agents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, active-controlled, three-arm superiority trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Clotrimazole 1% | Active comparator | Drug: Group AClotrimazole 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 B: Prunus salicina Extract Drops | Experimental | Drug: Group BPrunus 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 C: Prunus salicina Nanoparticle Drops | Experimental | Drug: Group CChitosan 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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AClotrimazole 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: Clotrimazole 1% |
| Group BPrunus 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: Prunus salicina Extract Drops |
| Group CChitosan 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: Prunus salicina Nanoparticle Drops |
Primary outcome
Mycological Clinical Cure Rate at Day 14
Time frame: Day 14 (end of treatment)
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.
Treatment Response Classification at Day 14
Time frame: 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.
5 secondary outcomes
Symptom Severity Score
Time frame: Days 0, 3, 5, 7, and 14
Sign Severity Score
Time frame: Days 0, 3, 5, 7, and 14
Microbiological Clearance
Time frame: Day 0 and Day 14
Recurrence Rate
Time frame: 2 weeks post treatment
Number of Participants with Adverse Events
Time frame: Day 0 - Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Otomycosis
Not yet recruiting
Terbinafine Hydrochloride for the Treatment of Otomycosis
Otomycosis, Fungal Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aliaa Hussein contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A, Group B and Group C in people with Otomycosis and Antifungal Agents, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa Hussien (01003041632, aliaagamal2622@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological Clinical Cure Rate at Day 14 (time frame: Day 14 (end of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.