NCT04099212Unknown不适用
OBSERVATIONAL CASE-ONLY PROSPECTIVE STUDY OF EFFECTIVENESS AND SAFETY OF 15% TOPICAL RESORCINOL FOR ADULTS WITH HURLEY I-II HIDRADENITIS SUPPURATIVA.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the change in the disease severity
研究概览
简要总结
Prospective, observational cross-sectional study to evaluate the response of patients with HS I-II to monotherapy treatment of topical resorcin 15%, taking into account its safety, impact on quality of life and subclinical evolution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Diagnosed with HS Hurley I-II degree.
- •Patients that have at least 1 or more swollen up nodules and/or abscess.
- •Availability of affected region control ultrasound prior to resorcine treatment beginning.
排除标准
- •Age < 18 years.
- •Number of draining fistula above
- •Patients in active treatment with immunomodulators.
- •Patients in active treatment with antibiotics.
结局指标
主要结局
Evaluate the change in the disease severity
时间窗: Up to 16 weeks
Score change in the Hidradenitis Sartorius modified score
次要结局
- Evaluate the security of the treatment(Up to 16 weeks)
- Usage profile(Initial)
- Evaluate the changes in the patient´s quailty of life due to the treatment(Up to 16 weeks)
- Evaluate the change in the disease severity.(Up to 16 weeks)
- Evaluate the changes in the patient´s quailty of life due to the treatment 2(Up to 16 weeks)
- Evaluate the frequency of responders(Up to 16 weeks)
- Total and partial ultrasound responders frequency of distribution.(Up to 16 weeks)
研究者
研究点 (1)
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