Efficacy of Self Vs. Physician Application of Triamcinolone-Econazole in Otomycosis

NCT06431542 | Completed Phase 4

• 1 other identifier: XMZSYYKY2024-047
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Otomycosis

Keywords

triamcinolone acetonide econazole cream; otomycosis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (1)

• recurrece rate

  3 months

Study Arms (2)

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.

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.

Procedure: physician-applied Triamcinolone Acetonide Econazole Cream

Interventions

physician-applied Triamcinolone Acetonide Econazole Cream PROCEDURE

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.

physician-applied medication group

patient-applied Triamcinolone Acetonide Econazole Cream PROCEDURE

The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab.

patient-applied medication group

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Xiamen University Zhongshan Hospital

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Otomycosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Chunsheng Chunsheng

  Xiamen University Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 28, 2024
• Study Start: June 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available within six months after the completion of the study and will remain accessible for at least ten years.
• Access Criteria: The data will be open to peer-reviewed researchers. Researchers requesting access to the data must submit a research proposal and pass our review process. All data requestors must also adhere to a data use agreement.

Locations

CN (1)