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

Otomycosis Clinical Trial

Official title:

Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431542
• Other study ID #: XMZSYYKY2024-047
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Zhongshan Hospital Xiamen University
• Contact: Chunsheng Ye, MD
• Phone: +8613400661815
• Email: 578881502[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy.

Related Conditions & MeSH terms

• Otomycosis

Intervention

Procedure:
• physician-applied Triamcinolone Acetonide Econazole Cream
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 Cream
The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab.

Locations

Country	Name	City	State
China	Xiamen University Zhongshan Hospital	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	recurrece rate	Recurrence rate is assessed six months later during a follow-up examination, where the presence of abnormal secretions in the ear canal and the recurrence of symptoms are noted.	6 months