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

Phase 4

Completed

• Conditions: Otomycosis
• Interventions: Procedure: physician-applied Triamcinolone Acetonide Econazole Cream; Procedure: patient-applied Triamcinolone Acetonide Econazole Cream

• Registration Number: NCT06431542
• Lead Sponsor: Zhongshan Hospital Xiamen University

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.

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 Timeline

• Study First Submitted: 2024-05-18
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-28
• Study Start: 2024-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physician-applied medication group	physician-applied Triamcinolone Acetonide Econazole Cream	The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications.
patient-applied medication group	patient-applied Triamcinolone Acetonide Econazole Cream	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.

Primary Outcome Measures

Name	Time	Method
treatment efficacy	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.

Secondary Outcome Measures

Name	Time	Method
recurrece rate	3 months	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.

Trial Locations

Locations (1)

Xiamen University Zhongshan Hospital; 🇨🇳 Xiamen, Fujian, China