A Prospective, Multicenter, Parallel, Randomized, Blinded Study of the Efficacy and Safety of the DTS-G2 System in Patients With Axillary Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Miramar Labs
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
研究概览
简要总结
This is a prospective, multi-center, parallel, randomized, blinded study. The study has two groups, where in one study group the subjects receive treatment for axillary hyperhidrosis (excessive underarm sweating) with the DTS-G2 System in both axilla ("treatment group"). The other study group receives a sham treatment in both axilla where the subjects will have the same procedure performed but no energy from the device will be applied ("sham group"). Subjects will be randomized in a 2:1 ratio (treatment group: sham group).
Subjects enrolled in the study will be blinded regarding which study group they are in. The study hypothesis is that subjects that receive the treatment will have a reduction in underarm sweating compared to those in the sham group, as measured by a quality of life questionnaire.
All subjects will undergo follow up assessments at 14 days, 30 days, 3 months and 6 months post final treatment session. Subjects randomized to the treatment group will also have follow-up visits at 9 months and 12 months post final treatment session.
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
- Double (Participant, Outcomes Assessor)
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
- •baseline gravimetric measurement of spontaneous resting sweat production of at least 50 mg/5 min at room temperature in each axilla
- •poor quality-of-life rating on the Hyperhidrosis Disease Severity Scale
- •primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria
- •female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study including follow-up period
- •female subjects over 40 must have had a mammogram in the last 2 years
- •subjects must be willing to comply with study visits and requirements
排除标准
- •subject has secondary hyperhidrosis (e.g., endocrinopathy, medications)
- •subject has active infection
- •subject is pregnant or lactating
- •subject has had prior surgery for axillary hyperhidrosis
- •subject has had axillary injections of botulinum toxin A in the last year
- •subject has used prescription antiperspirants in the last 14 days or plans to use them during the study period
- •subject has used oral anticholinergics in the last 4 weeks
- •subject is a prisoner or under incarceration
- •subject is participating in a another clinical trial (or has in the last 30 days)
- •subject has history of cancer (some exceptions)
- •subject has a pacemaker or other electronic implant
- •subject requires supplemental oxygen
研究组 & 干预措施
Treatment with DTS-G2 System
Subjects receive treatment with the DTS-G2 System (an energy-based medical device) in both axilla. Multiple treatment sessions may be used.
干预措施: DTS-G2 System (Device)
Sham treatment
All elements of the treatment are given except that no energy is delivered. Multiple treatment sessions may be used.
干预措施: DTS System (Sham treatment) (Device)
结局指标
主要结局
Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.
时间窗: 30 days post-treatment
The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors: 1. - My underarm sweating is never noticeable and never interferes with my daily activities 2. - My underarm sweating is tolerable but sometimes interferes with my daily activities 3. - My underarm sweating is barely tolerable and frequently interferes with my daily activities 4. - My underarm sweating is intolerable and always interferes with my daily activities
次要结局
- Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.(6 months post-treatment)
- Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit(12 months)
- Percentage of Subjects With Reported Adverse Events(6 months post-treatment)