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

Completed · Not applicable

Conditions studied: Sweating Increased Armpits

In brief

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.

Key facts

Study ID

NCT03107065

Run by

ThermiGen, LLC

People needed

20

Starts

2016-12-08

Expected to finish

2017-09-06

Last updated by the study team

2017-12-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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;

Where it is running

• Faces+ Plastic Surgery, Dermatology, Skin and Laser — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.