OtomycosisPhase 4NCT06431542
Efficacy of Self Vs. Physician Application of Triamcinolone-Econazole in Otomycosis
A Phase 4 study testing physician-applied Triamcinolone Acetonide Econazole Cream and patient-applied Triamcinolone Acetonide Econazole Cream in people with Otomycosis, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment. Read more about this study
- Who is it for?
- Ages 4 to 100 years
- Conditions the study is for
- Otomycosis
- What is being tested?
- physician-applied Triamcinolone Acetonide Econazole Cream and patient-applied Triamcinolone Acetonide Econazole Cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 4 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing; 2. Physical examination findings:presence of fungal hyphae or accumulations that appear creamy or cheese-like or resembling abnormal earwax (crusts, films) , skin redness, erosion, swelling, or granulation tissue within the ear canal; 3. Positive results in fungal culture.
Who cannot join
- The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis
to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment.
Read the detailed description
The study analyzes the clinical characteristics, including symptoms and physical examinations, as well as the types of fungal infections. It compares the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in treating otomycosis two weeks after starting treatment. Furthermore, the study also compares the recurrence rates six months after treatment.
- Conditions
- Otomycosis
- Being tested
- physician-applied Triamcinolone Acetonide Econazole Cream, patient-applied Triamcinolone Acetonide Econazole Cream
- Keywords
- triamcinolone acetonide econazole cream, otomycosis
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician-applied Triamcinolone Acetonide Econazole CreamProcedure or surgery
The doctor applies the Triamcinolone Acetonide Econazole Cream onto a thin cotton swab and gently inserts it deep into the ear canal, evenly spreading the cream around the sides of the ear canal and on the surface of the eardrum.
patient-applied Triamcinolone Acetonide Econazole CreamProcedure or surgery
The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab.
| Study group | Role | What they receive |
|---|---|---|
| patient-applied medication group | Active comparator | The doctor provided detailed instructions for the patient to self-apply Triamcinolone Acetonide Econazole Cream to the external auditory canal once daily for two weeks. Receives: Procedure: patient-applied Triamcinolone Acetonide Econazole Cream |
| physician-applied medication group | Experimental | The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications. Receives: Procedure: physician-applied Triamcinolone Acetonide Econazole Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment efficacy
Treatment efficacy is defined as the proportion of patients who are effective after two weeks of treatment. Effectiveness is defined by the absence of abnormalities in the external auditory canal and the alleviation of symptoms.
Measured: 2 weeks
Secondary outcomes (1)
recurrece rate
Recurrence rate is assessed three months later during a follow-up examination, where the presence of abnormal secretions in the ear canal and the recurrence of symptoms are noted.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jun 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunsheng Chunsheng, Principal investigator, Xiamen University Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431542
- Sponsor's protocol ID
- XMZSYYKY2024-047
- Status last verified
- Oct 2024
- First submitted
- 18 May 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis
- ClinicalTrials.gov ID
- NCT06431542
- Acronym / sponsor ID
- XMZSYYKY2024-047
- Conditions
- Otomycosis
- Keywords
- triamcinolone acetonide econazole cream, otomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 28 May 2024 (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.
to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment.
Detailed description
The study analyzes the clinical characteristics, including symptoms and physical examinations, as well as the types of fungal infections. It compares the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in treating otomycosis two weeks after starting treatment. Furthermore, the study also compares the recurrence rates six months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-applied medication group | Active comparator | Procedure: patient-applied Triamcinolone Acetonide Econazole CreamThe doctor provided detailed instructions for the patient to self-apply Triamcinolone Acetonide Econazole Cream to the external auditory canal once daily for two weeks. |
| physician-applied medication group | Experimental | Procedure: physician-applied Triamcinolone Acetonide Econazole CreamThe doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications. |
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing; 2. Physical examination findings:presence of fungal hyphae or accumulations that appear creamy or cheese-like or resembling abnormal earwax (crusts, films) , skin redness, erosion, swelling, or granulation tissue within the ear canal; 3. Positive results in fungal culture.
Key exclusion criteria (1 listed)
- The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy.
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 |
|---|---|---|
| physician-applied Triamcinolone Acetonide Econazole CreamThe doctor applies the Triamcinolone Acetonide Econazole Cream onto a thin cotton swab and gently inserts it deep into the ear canal, evenly spreading the cream around the sides of the ear canal and on the surface of the eardrum. | Procedure or surgery | physician-applied medication group |
| patient-applied Triamcinolone Acetonide Econazole CreamThe patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab. | Procedure or surgery | patient-applied medication group |
Primary outcome
treatment efficacy
Time frame: 2 weeks
Treatment efficacy is defined as the proportion of patients who are effective after two weeks of treatment. Effectiveness is defined by the absence of abnormalities in the external auditory canal and the alleviation of symptoms.
1 secondary outcome
recurrece rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
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. This study is not recruiting at the moment.
Chunsheng Chunsheng principal investigator
Xiamen University Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing physician-applied Triamcinolone Acetonide Econazole Cream and patient-applied Triamcinolone Acetonide Econazole Cream in people with Otomycosis, run by Zhongshan Hospital Xiamen University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Nov 2024. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment efficacy (time frame: 2 weeks). 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 1 Nov 2024.