A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 7
- 主要终点
- Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
详细描述
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and assent (for subjects under legal adult age).
- •Age ≥9 years.
- •Primary palmar hyperhidrosis for at least 6 months duration.
- •Average sweat severity score of ≥4 at Baseline.
- •Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
- •Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
- •Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
排除标准
- •Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
- •Prior surgical procedure for hyperhidrosis.
- •Iontophoresis for the palms within 4 weeks of Baseline.
- •Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
- •Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
- •Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
- •Known history of Sjögren's syndrome or Sicca syndrome.
- •History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
- •Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
研究组 & 干预措施
Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
干预措施: Glycopyrronium cloth, 2.4% (Drug)
Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
干预措施: Vehicle (Drug)
Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
干预措施: Glycopyrronium cloth, 2.4% (Drug)
Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
干预措施: Vehicle (Drug)
Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
干预措施: Glycopyrronium cloth, 2.4% (Drug)
Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
干预措施: Vehicle (Drug)
Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
干预措施: Glycopyrronium cloth, 2.4% (Drug)
Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
时间窗: Baseline, Week 2
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis \[score on a scale from 0 (better) -10 (worse)\].
次要结局
- Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2(Baseline, Week 2)
- Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2(Baseline, Week 2)
- Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2(Baseline, Week 2)
- Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2(Baseline, Week 2)