Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 145
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
研究概览
简要总结
The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 - 70 years of age
- •diagnosis of primary axillary hyperhidrosis
- •HDSS score of ≥3
- •threshold sweat production/axilla in 5 minutes as measured gravimetrically
- •willingness to shave underarms prior to each study visit
排除标准
- •botulinum toxin treatment in the prior 6 months
- •signs of infection in the axilla
- •skin affliction in the axilla requiring medical treatment
- •oral anticholinergic treatment
- •use of antiperspirants, deodorants, powders, or lotions
- •use of axillary depilatories or axillary epilation
- •history of surgery or other interventions for axillary hyperhidrosis
- •female subjects who are pregnant or are nursing a child
结局指标
主要结局
Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
时间窗: Baseline, Week 12
The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.
次要结局
- Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points(Baseline, Weeks 4, 8, 12 and 18)
- Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%(Baseline, Weeks 4, 8, 12 and 18)