Comparison of microwaves thermolysis and botulinum toxin A for treatment of increased sweat from armpits

Phase 1

• Conditions: Axillary hyperhidrosis; MedDRA version: 20.0Level: PTClassification code 10020642Term: HyperhidrosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-000877-10-DK
• Lead Sponsor: Bispebjerg Hospital, Department of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-19
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study aim is to assess and compare treatment effect of MWT and BTX-A for axillary hyperhidrosis with focus on longevity. We also aim to assess patient satisfaction, local skin responses and adverse reactions in relation to treatment.;Secondary Objective: Not applicable;Primary end point(s): Axillary sweat reduction following treatment with MWT and BTX-A at 6 months follow-up;Timepoint(s) of evaluation of this end point: Baseline compared to 6 months follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): o Patient satisfaction of BTX-A and MWT treatments for axillary hyperhidrosis at 6 and 12 months follow-up<br>o Axillary sweat reduction following treatment with MWT and BTX-A at 1, 3, 9 and 12 months<br>o Quality of life at 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A<br>o Axillary odor reduction 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A <br>o Axillary hair reduction at 6 months compared to baseline evaluated with clinical photos<br>o Procedure-related discomfort during treatment with MWT and BTX-A<br>o Local skin response and treatment-related adverse effects during and following treatment with MWT and BTX-A;Timepoint(s) of evaluation of this end point: Baseline, 2 days FU (tel.), 1-, 3-, 6-, 9- and 12-months follow-up