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临床试验/NCT06431542
NCT06431542已完成4 期

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

Zhongshan Hospital Xiamen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
treatment efficacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing;
  • 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;
  • Positive results in fungal culture.

排除标准

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

结局指标

主要结局

treatment efficacy

时间窗: 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.

次要结局

  • recurrece rate(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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