A Prospective Study Assessing the Effect of Patient Characteristics on Treatment Response in Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Weeks till treatment response
研究概览
简要总结
This study will describe the treatment of hyperhidrosis (excessive sweating) in clinical practice and explore the effect of patient characteristics on treatment response. This study will follow 200 people with hyperhidrosis over 18 months. Anyone with primary hyperhidrosis (excessive sweating not due to another medical condition) over the age of 12 may participate. Study participants will have multiple office visits during which they will asked to rate the severity of their sweat production in multiple areas (i.e. underarms, hands, feet), answer a questionnaire regarding their disease and treatment, and undergo a non-invasive measurement of sweat production called gravimetry. Gravimetry is performed by placing absorbent material in an area, such as the underarms, for a set amount of time and then measuring the amount of sweat collected. In between clinic visits, study participants will be contacted electronically to answer several questions regarding their disease and treatment.
详细描述
Subject Recruitment
Recruitment will take place at SLUCare Dermatology Des Peres Clinic. Patients with non-study related appointments with Dr. Glaser regarding the management of primary hyperhidrosis will be approached by a research member. Patients will be given ample time to review study design and have questions and concerns addressed. After inclusion and exclusion criteria, study purpose and design, signed consent (parent or guardian will sign if subject is a minor), assent (for minors only, not signed) and HIPAA release are attained, the patients will be enrolled in the study.
The investigators will be recruiting two types of patients for this study. (1) New patients being seen for evaluation for primary hyperhidrosis. These subjects will be presenting to the hyperhidrosis clinic for the first time. If enrolled, these subjects will have all data prospectively collected. (2) Established patients being seen for ongoing management of primary hyperhidrosis who have documented baseline gravimetric measurements (defined as measurements taken while the patient was undergoing no active therapies for primary hyperhidrosis). These subjects will be presenting to the hyperhidrosis clinic for continued care. If enrolled, these subjects will have some data collected retrospectively with the remainder collected prospectively (see below for details).
Withdrawal or Discontinuation
Subjects may withdraw from the study at any time. If a subject desires withdraw from the study, the subject will be give a reason for study withdraw which will be included in publication. If a subject misses a scheduled visit the subject will be contacted via phone to ask if the subject is withdrawing from the study or reschedule a visit.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race who has received the diagnosis of primary Hyperhidrosis at any site
- •Patients receiving continued treatment of primary Hyperhidrosis with baseline gravimetrics (established patients only) performed at SLUCare Dermatology Des Peres clinic. Baseline gravimetrics are defined as measurements taken during times of no active disease interventions.
排除标准
- •Received the following therapies at the site being evaluated prior to baseline gravimetrics:
- •Botulinum toxin injections 6 months prior to baseline gravimetric data collection.
- •Applied Aluminum chloride on day of baseline gravimetric data
- •Ongoing iontophoresis therapy at time of baseline gravimetric data
- •Oral systemic anticholinergics 4 weeks prior to baseline gravimetric data
- •Received surgical intervention, suction and curettage, microwave thermolysis, or ultrasound therapy prior to baseline gravimetrics.
- •Patient has received diagnosis of secondary hyperhidrosis (i.e hyperhidrosis due to an underlying medical condition such as hyperthyroidism)
- •Younger than 12 years of age.
- •Does not desire study participation or is unable to consent.
结局指标
主要结局
Weeks till treatment response
时间窗: 18 months
We will measure the weeks required to reach treatment response defined as HDSS of 1 or 2.
次要结局
- Number of treatment changes(18 months)
- Number of treatments at the time of treatment response.(18 months)
- Percent reduction in gravimetric sweat measurements(18 months)
- Disease impact(18 months)
研究者
Dee Anna Glaser, MD
Interim Chair, Department of Dermatology
St. Louis University