Axillary hyperhidrosis MedDRA version: 20.0 Level: PT Classification code 10020642 Term: Hyperhidrosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: BOTOX
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum Toxin A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit
Sponsors
Bispebjerg Hospital, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Patient satisfaction of BTX-A and MWT treatments for axillary hyperhidrosis at 6 and 12 months follow-up o Axillary sweat reduction following treatment with MWT and BTX-A at 1, 3, 9 and 12 months o Quality of life at 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A o Axillary odor reduction 1, 3, 6, 9 and 12 months following treatment with MWT and BTX-A o Axillary hair reduction at 6 months compared to baseline evaluated with clinical photos o Procedure-related discomfort during treatment with MWT and BTX-A 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 | — |
Countries
Denmark
Contacts
Public ContactGabriela Lladó Grove
Bispebjerg Hospital, Department of Dermatology
Outcome results
None listed