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

Xiamen University

Status and phase: Completed; Phase 4

Conditions: Otomycosis

Treatments: Procedure: patient-applied Triamcinolone Acetonide Econazole Cream; Procedure: physician-applied Triamcinolone Acetonide Econazole Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06431542

XMZSYYKY2024-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 4 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

patient-applied medication group

Active Comparator group

Description:

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.

Treatment:

Procedure: patient-applied Triamcinolone Acetonide Econazole Cream

physician-applied medication group

Experimental group

Description:

The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications.

Treatment:

Procedure: physician-applied Triamcinolone Acetonide Econazole Cream