A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 12
- 主要终点
- Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
研究概览
简要总结
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
详细描述
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.
Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.
Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.
PK blood samples will be taken from study subjects from selected centers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary axillary hyperhidrosis of at least 6 months's duration
- •Hyperhidrosis disease severity score of 3 or 4 at baseline
- •Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
- •Willing to refrain from using any other antiperspirant agent for the duration of the study.
- •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 in the axilla or near the axillary area, other than hyperhidrosis.
- •Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:
- •Botulinum toxin to the axillary area within 1 year of the baseline visit.
- •Axillary iontophoresis within 12 weeks of baseline visit.
- •Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past.
- •Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.
- •Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.
- •Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
- •Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
- •Pregnant or lactating women.
- •Use of an investigational drug within 30 days prior to the baseline visit.
- •Prior treatment with the study drug in a previous trial.
- •Any major illness within 30 days before the screening examination.
- •Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
研究组 & 干预措施
BBI-4000 Gel, 15%
High concentration of BBI-4000; BBI-4000 Gel, 15%
干预措施: BBI-4000 Gel, 15% (Drug)
BBI-4000 Gel, 5%
Low concentration of BBI-4000; BBI-4000 Gel, 5%
干预措施: BBI-4000 Gel, 5% (Drug)
BBI-4000 Gel, 10%
Middle concentration of BBI-4000; BBI-4000 Gel, 10%
干预措施: BBI-4000 Gel, 10% (Drug)
Vehicle
Vehicle (placebo); BBI-4000 Gel, 0%
干预措施: Vehicle (Drug)
结局指标
主要结局
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
时间窗: Baseline through Week 4 (Day 29)
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
次要结局
- Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4(Baseline through Week 4 (Day 29))
- Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)(Baseline through Week 4 (Day 29))
- Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4(Baseline through Week 4 (Day 29))