A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Percent change in the gravimetrically measured sweat production from baseline
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
详细描述
This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.
Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).
Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).
Pharmacokinetic information will also be collected.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects from 18 to 45 years of age in good general health.
- •Primary axillary hyperhidrosis of at least 6 months duration.
- •Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- •Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
- •Use of a medically appropriate contraceptive method.
排除标准
- •Prior axillary use of botulinum toxin within 2 years of study entry.
- •Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
- •Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
- •Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
- •History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
- •Known condition that may cause hyperhidrosis.
- •Use of an investigational drug within 30 days prior to entry into this study.
研究组 & 干预措施
Low Strength BBI-4000 and Vehicle
干预措施: BBI-4000 (Drug)
High Strength BBI-4000 and Vehicle
干预措施: BBI-4000 (Drug)
结局指标
主要结局
Percent change in the gravimetrically measured sweat production from baseline
时间窗: Week 2
次要结局
- Absolute change in the gravimetrically measured sweat production from baseline(Week 2)
- Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.(Week 2)
- Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline(Week 2)