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Completed

NCT Number: NCT06431542

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

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Key information

Conditions

Otomycosis Bacterial Infections and Mycoses Ear Diseases Infections Mycoses Otorhinolaryngologic Diseases

Age range

4 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xiamen University Zhongshan Hospital

Xiamen, Fujian, 361000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. recurrece rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Hospital Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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