Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The effectiveness of miraDry treatment
研究概览
简要总结
Primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat production without an underlying cause. The disease usually affects the axillae but can also involve palms, soles of the feet or face and causes major problems in many social situations with a negative impact on quality of life and mental health.
In this study, the investigators want to investigate the effect of microwave therapy (MiraDry®) on self-rated sweating, quality of life and anxiety in participants with severe axillary hyperhidrosis. The study also aims to evaluate the safety (side effects) of the method and long term effects over 1 year of follow upp.
详细描述
The study is conducted during several visits or telephone follow-ups at the clinic over a period of 12 months and each patient receives a maximum of two treatments with MiraDry® (at 3-month intervals). 100 participants are planned to participate in the study.
The primary objective is to evaluate the effectiveness of the miraDry ® treatment measured by Hyperhidrosis Disease Severity Scale(HDSS).
Secondary objectives are to evaluate the side effects and the quality of Life by assessment of The Dermatology life Quality Index, The Hyperhidrosis Quality of Life Index, and Hospital Anxiety and Depression Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will recruit participants diagnosed with primarily axillary hyperhidrosis
- •Informed consent is required.
- •HDSS 3 or 4 (the criteria used in Sweden to allow hospital-based intervention).
排除标准
- •Participants
- •who are unable to provide informed consent,
- •have known allergies to lidocaine, chlorhexidine, and/or epinephrine,
- •are pregnant,
- •are unable to take oral antibiotics or antiseptic washes,
- •have heart pacemakers or other electronic device implants,
- •who need supplemental oxygen,
- •have had axillary surgery procedures for hyperhidrosis,
- •with previous hidradenitis suppurativa or other local infections
- •had previous cancer in the treated area are not eligible to participate in this study
结局指标
主要结局
The effectiveness of miraDry treatment
时间窗: 1 year
The effect of the treatment will be measured by the participants completing the Hyperhidrosis Disease Severity Scale (score 1 to 4, where a score of 3 or 4 indicates severe hyperhidrosis and a score of 1 or 2 indicates mild or moderate hyperhidrosis) att baseline (prescreening), at 3 month follow-up visit and 1 year follow-up visit.
次要结局
- Frequency of side effects(1 year)
- Hyperhidrosis Quality of Life Index assessment(1 year)
- Dermatology Life Quality Index assessment(1 year)
- Hospital anxiety and depression scale assessment(1 year)
研究者
Emanuela Micu
Principal investigator, MD, PhD
Region Östergötland