NCT04159610撤回2 期
A Randomized, Open-Label, Multiple Dose, Two-Period Crossover Study Evaluating Maximum Use 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% in Men and Women with Primary Axillary Hyperhidrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
- 主要终点
- Measurement of the Steady State systemic Levels of glycopyrronium
研究概览
简要总结
The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 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
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Active Comparator
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
干预措施: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use (Drug)
WO 3970
Experimental
Formulation containing WO 3970 for topical application
干预措施: WO3970 (Drug)
结局指标
主要结局
Measurement of the Steady State systemic Levels of glycopyrronium
时间窗: Day-1, Day 1 to Day 13, Day 16
次要结局
- 12-lead ECG(Screening, Day 1-13 of study period 1 and period 2)
- Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))(Day -1, Day 1 to 13, Day 16)
- Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))(Day -1, Day 1 to 13, Day 16)
- Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))(Day -1, Day 1 to 13, Day 16)
- Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))(Day -1, Day 1 to 13, Day 16)
- Adverse events (AEs)(Day -1 of study period 1 to Day 16)
- Clinical chemistry(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Hematology(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Urinalysis(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- BP(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Respiratory rate(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Temperature(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Heart rate(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Physical examination(Screening, Day -1, Day 16)
- Local tolerability(Day -1, Day 1-13, Day 16 of study period 1 and period 2)
- Sweat production by gravimetric measurement(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Hyperhidrosis Disease Severity Scale (HDSS)(Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2)
- Hyperhidrosis Quality of Life Questionnaire (HydroQoL)(Day -1, Day 1 to 13 of period 1 and period 2)
研究者
相似试验
已完成
3 期
Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.Primary Axillary HyperhidrosisNCT03658616Dr. August Wolff GmbH & Co. KG Arzneimittel518
已完成
2 期
Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact DermatitisAllergic Contact DermatitisNCT03680131Edesa Biotech Inc.211
已完成
3 期
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)Acne VulgarisNCT02608450Cassiopea SpA708
已完成
3 期
A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)Acne VulgarisNCT02608476Cassiopea SpA732
已完成
2 期
Safety and Efficacy Study of Bimosiamose Cream to Treat PsoriasisPsoriasisNCT00823693Revotar Biopharmaceuticals AG107