ongevity of microwave thermolysis and botulinum toxin A for treatment of axillary hyperhidrosis:a randomized intra-individual trial

Bispebjerg Hospital, Department of Dermatology0 个研究点目标入组 30 人开始时间: 2021年3月19日最近更新: 2021年7月21日

适应症

试验速览

暂无简介。

•Eligible patients for this study must meet the following criteria:
•1) Subject has provided written informed consent
•2) Subject is 18 years of age or older
•3) A unilateral HDSS score of 3 or 4 for each axilla
•4) 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).
•5) 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Candidates will be excluded if the following conditions apply:
•1) Patients with generalized hyperhidrosis
•2) Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
•3) Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
•4) Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
•5) Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
•6) Breast tissue in the axillae
•7) Treatment with Isotretinoin within the past 6 months
•8) Axillary laser or IPL treatment within the past 6 months
•9) Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
•10) Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
•11) Prior axillary surgery
•12) Limited motion in the shoulder joint or neurologic deficit in upper limb
•13) History of diseases resulting in muscle weakness (ALS, Lou Gehrig’s), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
•14) Axillary lymph node enlargement or -removal or lymphedema in either upper limb
•15) History of hidradenitis suppurativa or history of reoccurring infections/abscesses
•16) History of breast cancer
•17) Electronic device implant
•18) If female; lactating, pregnant or planning on becoming pregnant during the study

发起方

Bispebjerg Hospital, Department of Dermatology