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

ThermiGen

Status

Completed

Conditions

Sweating Increased Armpits

Treatments

Device: Thermi Radiofrequency

Study type

Interventional

Funder types

Industry

Identifiers

NCT03107065

THERMI_0007

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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;