A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 21
- 主要终点
- Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
详细描述
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.
Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.
Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK samples will be taken from 20 to 30 subjects participating in the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older.
- •Primary, axillary hyperhidrosis of at least 6 months duration.
- •A Hyperhidrosis Disease Severity Score (HDSS) of 3or
- •A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
- •Male or non-pregnant, non-lactating females.
排除标准
- •Prior surgical procedure for hyperhidrosis.
- •Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
- •Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
- •Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
- •Prior axillary treatment with axillary iontophoresis within 4 weeks.
- •Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
- •Known history of a condition that may cause secondary hyperhidrosis.
- •Known history of Sjögren's syndrome or Sicca syndrome.
- •Abnormal findings on screening ECG deemed clinically significant by the Investigator.
研究组 & 干预措施
glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
干预措施: glycopyrrolate, 1.0% (Drug)
glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
干预措施: glycopyrrolate, 2.0% (Drug)
glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
干预措施: glycopyrrolate, 3.0% (Drug)
glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
干预措施: glycopyrrolate, 4.0% (Drug)
Vehicle
Vehicle Topical Wipes
干预措施: Vehicle (Other)
结局指标
主要结局
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
时间窗: Baseline - Week 4
HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (Best), 2, 3, 4 (Worst)
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
时间窗: Baseline - Week 4
Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.
次要结局
- Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4(Baseline - Week 4)
- Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6(Baseline - Week 6)
- Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4(Baseline - Week 4)
- Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6(Baseline - Week 6)