Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue

Study Overview
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Brief Summary
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This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve excessive sweating of the axilla(s). In this study, Temporary Relief is defined as improvement on the DLQI. Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five visits are planned for this study. A punch biopsy will be collected (prior to and post treatment and analyzed to determine the degree of impact to the tissue after the electrocoagulation treatment. Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported). The total length of the study is approximately 4 months.

Detailed Description
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This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to alleviate or improve symptoms associated with axillary sweating. In this study, Temporary Relief is defined as improvement on the DLQI. A total of 20 male and female healthy volunteers between the age of 18 and 50 will be enrolled in this study. Subjects who sign the informed consent form and meet all entry criteria will be assigned a unique number/code to preserve confidentiality. A total of five visits are planned for this study as described below: Visit 1: Screening visit - (Day 0) Visit 2: Single Treatment Visit 3: Day 30 (± 7 days) Visit 4: Day 60 (± 7 days) Visit 5: Day 90 (± 7 days) A punch biopsy will be collected at Visit 1(screening), Visit 2 (post-treatment) and Visit 4 (Day 60). The purpose of the punch biopsy is to evaluate the degree of impact to the axillary organ after the electrocoagulation treatment when compared to pre-treatment at Visit 1. Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported). The total length of the study is approximately 4 months.

Official Title
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A Pilot, Open-Label, Single-Center, Single-Treatment, Safety And Effectiveness Evaluation Of Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands

Conditions
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Sweating Increased Armpits

Intervention / Treatment
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* Device: Thermi Radiofrequency


Participation Criteria
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Eligibility Criteria
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5Inclusion Criteria Male or female between the age of 18 and 50 inclusive Focal, visible excess sweating present for at least 6 months Self-reported excess sweating that becomes visible through clothing and has a negative psychosocial impact on the subject's quality of life At least any two of the following: Bilateral and symmetrical excessive sweating Impairs activities of daily life At least one episode per week Age of onset <25 years Desire to reduce / improve the condition Willing to refrain the use of deodorant products containing Aluminum Chloride one to two weeks prior to treatment and for the duration of the study Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation Cooperative, reliable, and able to read and comprehend English Able to read, understand, sign and date the informed consent document (English only) Able and willing to comply with the schedule visit(s) and study requirements. Exclusion Criteria Subjects presenting with any of the following will not be included in the study Prior use of botulinum toxin injections into axilla within the last 6 months Priory Miradry treatments Prior surgical dissection, curettage or liposuction Current or prior sympathectomy Current or prior laser therapy to axilla for hyperhidrosis Female subject in menopause stage Current use of oral medications such as oxybutynin, glycopyrolate, clonazepam, clonidine, phenoxybenzamine or propranolol Use within 7 days preceding surgery of ibuprofen, , non-steroidal anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia) Subjects who have a pacemaker, implantable defibrillators, metal stents, implants or other monitoring equipment History or current injury to the axilla or nearby anatomical areas. Clinically significant wounds, lesions or acute infections including, dermatitis, lupus or other autoimmune disease affecting the dermis Pregnant or planning pregnancy prior to the end of study participation History or current diagnosis of cancer of any type History of uncontrolled cardiovascular disease(i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease) Known hypersensitivity to local anesthetic medications History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants History of AIDs/HIV Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirement and/or record the necessary study measurements Any family member of the investigator or investigational staff, or an employee of the investigator. Participation in any other investigational study within 30 days prior to consent;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single treatment<br>Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands | Device: Thermi Radiofrequency<br>* Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index (DLQI) improvement post treatment | subjective improvement from initial to post questionnaire on the DLQI | Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sweating