NCT05057117已完成4 期
Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial
Merete Haedersdal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subjective change in axillary sweat
研究概览
简要总结
This trial aims is to assess and compare treatment effect of microwave thermolysis and botulinum toxin A for axillary hyperhidrosis with focus on longevity. The investigators also aim to assess patient satisfaction and adverse reactions in relation to treatment.
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
- 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
- •Subject has provided written informed consent
- •Subject is 18 years of age or older
- •A unilateral HDSS score of 3 or 4 for each axilla
- •A gravimetric measurement of at least 50 mg/5 min for women and 100 mg/5 min for men in at least one axilla. The contralateral axilla should not be below 40 mg (women) and 80 mg (men).
- •Women of childbearing potential must be confirmed not pregnant by a negative u-HCG prior to study treatment and must use a safe contraceptive method at baseline.
排除标准
- •Subjects with generalized hyperhidrosis
- •Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
- •Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
- •Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
- •Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
- •Breast tissue in the axillae
- •Treatment with Isotretinoin within the past 6 months
- •Axillary laser or IPL treatment within the past 6 months
- •Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
- •Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
- •Prior axillary surgery
- •Limited motion in the shoulder joint or neurologic deficit in upper limb
- •History of diseases resulting in muscle weakness (ALS, Lou Gehrig's), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
- •Axillary lymph node enlargement or -removal or lymphedema in either upper limb
- •History of hidradenitis suppurativa or history of reoccurring infections/abscesses
- •History of breast cancer
- •Electronic device implant
- •If female; lactating, pregnant or planning on becoming pregnant during the study
- •Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)
研究组 & 干预措施
Botulinum toxin A
Active Comparator
One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla
干预措施: Botulinum toxin A (Drug)
Microwave thermolysis
Active Comparator
One standard treatment (energy level 5) with microwave thermolysis in one axilla
干预措施: Microwave thermolysis (Device)
结局指标
主要结局
Subjective change in axillary sweat
时间窗: Baseline - 6 months
Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale
次要结局
- Objective change in axillary sweat(Baseline - 6 months)
- Patient Satisfaction(Baseline - 6 months - 12 months)
- Adverse reactions(Baseline - 12 months)
研究者
Merete Haedersdal
Consultant in Dermatology, Clinical Professor
Bispebjerg Hospital
研究点 (1)
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