NCT03658616已完成3 期
Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.
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
- •Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4
- •At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes)
- •Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2
- •Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects
- •Willing and able to provide written informed consent
排除标准
- •Known allergy to any of the components in the investigational product.
- •Hypersensitivity against glycopyrrolate
- •Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis.
- •Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
- •Botulinum toxin treatment in the prior 4 months.
- •Angle closure glaucoma or its precipitation (narrow angle).
- •Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla.
- •Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study;
研究组 & 干预措施
WO3970
Experimental
Formulation containing WO3979 for topical application
干预措施: WO3970 (Drug)
Placebo of WO3988
Placebo Comparator
Formulation containing Placebo of WO3988 for topical application
干预措施: Placebo (WO3988) (Drug)
结局指标
主要结局
Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12
时间窗: Baseline (Day 1b), Week 12
Dose-confirming part: Absolute change in sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared with the placebo group.
时间窗: Baseline (Day 1a), Day 29
次要结局
- Dose-confirming part: Percentage of responders assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (≥2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group(Day 29)
- Dose-confirming part: Percentage of responders assessed by GM at Day 29 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline) in the 1% GPB group compared with the placebo group(Day 29)
- Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12(Week 12)
- Long-term part: Percentage of responders assessed by GM at Week 4 and Week 12 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline(Week 4, Week 12)
研究者
研究点 (1)
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