NCT05863104已完成2 期
An Open-label, Uncontrolled, Multicenter Study to Evaluate the Safety, Local Tolerability, Systemic Exposure, and Efficacy of 1% Glycopyrronium Bromide (GPB) Cream in Adolescents With Severe Primary Axillary Hyperhidrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of patients with Adverse Drug Reaction during treatment
研究概览
简要总结
The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of severe primary axillary hyperhidrosis with a PRHS score of ≥5 with symptoms for at least 3 months before Screening
- •At least 50 mg of sweat production in each axilla measured gravimetrically over a period of 5 minutes at room temperature along with a humidity consistent with the normal climate in that area (patients have to acclimatize to that room for at least 30 minutes before the measurement)
- •Adolescents of both sexes aged 12 to 17 years (until study completion) with a body mass index percentile ≥10 and ≤90 (according to Kromeyer-Hauschild et al 2001)
- •Local tolerability assessment (skin reaction) score = 0
排除标准
- •Secondary hyperhidrosis, ie, hyperhidrosis that is secondary to other underlying diseases such as (but not limited to) hyperthyroidism, lymphoma, and malaria
- •Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage, ultrasonic surgery, microwave treatment (miraDry), or laser treatment
- •Botulinum toxin treatment for the treatment of axillary hyperhidrosis in the previous 4 months
- •Hypersensitivity to glycopyrrolate, or to any of the excipients of the investigational medicinal product (IMP)
研究组 & 干预措施
Glycopyrronium Bromide (GPB) Cream
Experimental
Formulation containing Glycopyrronium Bromide (GPB) for topical application
干预措施: Glycopyrronium Bromide (GPB) Cream (Drug)
结局指标
主要结局
Number of patients with Adverse Drug Reaction during treatment
时间窗: Baseline to Day 57
Number of patients with a local tolerability assessment (skin reaction score) >0 during treatment
时间窗: Baseline to Day 57
Αbsolute change in GP plasma concentration from Baseline to Day 15
时间窗: Baseline to Day 15
次要结局
- Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 29(Baseline to Day 29)
- Absolute change in the Children's dermatology life quality index (CDLQI) score from Day 29 to Day 57(Day 29 to Day 57)
- Relative change in total sweat production assessed by GM from Day 29 to Day 57(Day 29 to Day 57)
- Proportion of responders assessed by GM at Day 29 and Day 57(Day 29 and Day 57)
- Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Baseline to Day 29 and Day 57(Baseline to Day 29 and Day 57)
- Absolute change in patient-rated hyperhidrosis severity (PRHS) score from Day 29 to Day 57(Day 29 to Day 57)
- Absolute change in the Children's dermatology life quality index (CDLQI) score from Baseline to Day 29 and Day 57(Baseline to Day 29 and Day 57)
- Absolute change in GP plasma concentration from Baseline to Day 8(Baseline to Day 8)
- Absolute change in GP plasma concentration from Day 8 to Day 15(Day 8 to Day 15)
- Frequency, severity, and relation of ADRs, SAEs, TEAEs, SUSARs, and discontinuations due to TEAEs(Screening to 14 Days after End of Treatment)
- Local tolerability based on the skin reaction score(Day 1, Day 29, Day 57/End of Treatment and 14 Days after Day 57/End of Treatment)
- Neurological assessment of anticholinergic effects by a 4-point scale(7 to 4 Days before Baseline, Day 15, Day 29, Day 43, Day 57/End of Treatment)
- Absolute change in logarithmic values of total sweat production assessed by GM from Baseline to Day 57(Baseline to Day 57)
- Absolute change in logarithmic values of total sweat production assessed by GM from Day 29 to Day 57(Day 29 to Day 57)
- Relative change in total sweat production assessed by GM from Baseline to Day 29 and Day 57(Baseline to Day 29 and Day 57)
研究者
研究点 (1)
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