A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Number of Treatment Emergent Adverse Events by Severity
概览
简要总结
To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.
详细描述
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar Hyperhidrosis.
Participating subjects will apply either BBI-4000 15% or vehicle gel topically to the palms of both hands once daily for 4 consecutive weeks. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety and tolerability will be assessed through collection of vital signs, adverse events, assessment of local skin responses, ECG, UPT and blood sampling.
Efficacy will be assessed through gravimetric sweat assessments as well as through the Hyperhidrosis Disease Severity Scale (HDSS).
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
- •Diagnosis of primary palmar hyperhidrosis
- •HDSS of 3 or 4 at baseline
- •Gravimetric test at baseline indicating at least 100 mg of sweat production at rest in each palm and a sum of at least 250 mg in both palms, in 5 minutes (room temperature)
- •Symptoms of at least 6 months' duration
- •Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study
排除标准
- •Any skin or subcutaneous tissue conditions of the palms, other than hyperhidrosis
- •Prior use of any prohibited medication(s) or procedure(s) within specified timeframe for the treatment of palmar hyperhidrosis, including:
- •Botulinum toxin to the palmar area within 9 months of baseline visit
- •Iontophoresis within 30 days of baseline visit
- •Palmar thermolysis, sympathectomy or surgical procedures of the palmar area any time in the past
- •Serotonergic agonist within 30 days of baseline visit
- •Any topical prescription treatment for hyperhidrosis within 30 days of baseline visit
- •Any over-the-counter topical antiperspirant/deodorant within 7 days of baseline visit
- •Use of anticholinergic agents within 30 days of baseline visit
- •Any oral or topical homeopathic or herbal treatment within 30 days of baseline visit
研究组 & 干预措施
BBI-4000, 15%
15% BBI-4000 (sofpironium bromide) topical gel
干预措施: BBI-4000, 15% (Drug)
Vehicle
Vehicle (placebo) gel
干预措施: Vehicle gel (Other)
结局指标
主要结局
Number of Treatment Emergent Adverse Events by Severity
时间窗: Baseline visit-Day 42 End of Participation
Each subject counted only once. Severity was rated Mild, Moderate or Severe.
次要结局
- Comparison of Number Subjects Achieving a Minimum of 50% Reduction in Gravimetrically Measured Sweat Production Day 29-baseline Among Both Treatment Arms(Baseline through day 29 (End of Treatment))
- Proportion of Randomized Subjects Achieving a 1-grade & 2-grade Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Day 29(Baseline to Day 29 (End of Treatment) Visit)
- Absolute Change (Day 29 - Baseline) in Palmar Gravimetrically Measured Sweat Production (GMSP) (mg) by Treatment Arm.(Baseline-Day 29 Participation)
- The Percent Change (%) Day 29 Combined GMSP From Baseline Combined GMSP Gravimetrically Measured Sweat Production (GMSP) in Combined (Right and Left) Palms.(Baseline-Day 29 End of Treatment)