Clinical Evaluation of the Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator (With the 24 Pin Tip) for the Treatment of Primary Focal Hyperhidrosis of the Axillae Using Fractional RF Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week
研究概览
简要总结
The InMode radio frequency Pro System with the Morpheus8 Applicator is a computerized system generating radio frequency energy, based on the underlying technology of Fractional RF. The Morpheus8 Applicator and 24 pin tip is used for the treatment of primary hyperhidrosis of the axillae
详细描述
Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode radio frequency Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode radio frequency Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post 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
- Double (Participant, Outcomes Assessor)
盲法说明
The treatments will be performed by an operator/technician who will not be blinded to the type of treatment that the subject is receiving. Objective assessment of clinical improvements such as starch-iodine tests will administered by blinded study personnel. The blinded evaluators will review photographs of the treatment areas that underwent the starch-iodine test and will be blinded as to which photos were taken at the baseline, 4-week follow-up, 12-week follow-up and 24-week follow-up visits. The HDSS, which is an objective assessment, will also be evaluated by a blinded study personnel. All subjects and study staff will be unblinded at the end of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 years of age or older at the time of consent.
- •Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS).
- •Subject has primary focal axillary hyperhidrosis evidenced by at least 6 months of visible, detectable, focal, exaggerated sweating without any apparent explanation and at least two of the following:
- •Bilateral and relatively symmetric
- •Impairs daily activities
- •Frequency of at least one episode per week
- •Age of onset less than 25 years old
- •Positive family history
- •Cessation of focal sweating during sleep
- •Subject is willing and able to comply with protocol requirements and all study visits
- •Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
- •Subject understands the study and has provided written informed consent
排除标准
- •Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
- •Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
- •Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- •Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.
- •Swollen axillary lymph nodes.
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
- •History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
- •Prior endoscopic thoracic sympathectomy, liposuction or other surgery for hyperhidrosis in the treated area. Injection of botulinum toxin in the treated area within one year
- •Use of Isotretinoin (Accutane®) within 6 months prior to study
- •Oral anticholinergic medication use (e.g., Robinul) or cholinomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
- •Currently participating in or recently participated in another clinical trial (within the last 30 days).
- •History of or current neurologic deficit in the treatment limb.
- •Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
- •Current or history of cancer, including skin cancer, or premalignant moles.
- •Injury in the treatment area or any other condition that, in the opinion of the investigator, might make treatment unsafe.
- •Subject has a pacemaker, defibrillator or other electronic implant anywhere in the body.
- •Permanent implant in the treated area such as metal plates, screws and metal piercing or silicon.
- •Females who are pregnant or nursing
- •Female subjects of childbearing potential not willing to use an acceptable form of contraception for the duration of the study.
结局指标
主要结局
A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week
时间窗: 4 weeks
A statistically significant difference in the percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week follow-up visit, in the treatment group compared to the sham group
次要结局
- Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.(4 weeks)
- Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2(12 weeks)
- Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity(4 weeks)