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

NCT03107065 | Completed

• 1 other identifier: THERMI_0007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sweating Increased Armpits

Keywords

Sweating

Outcome Measures

Primary Outcomes (1)

• Dermatology Life Quality Index (DLQI) improvement post treatment

  subjective improvement from initial to post questionnaire on the DLQI

  Day 60

Other Outcomes (2)

• Odor Scale (OS) Improvement post treatment

  Day 60 and Day 90

• Reduction of excessive sweating

  Day 60

Study Arms (1)

single treatment

EXPERIMENTAL

Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands

Device: Thermi Radiofrequency

Interventions

Thermi Radiofrequency DEVICE

Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation

single treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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)

Sponsors & Collaborators

• ThermiGen, LLC: lead

Study Sites (1)

Faces+ Plastic Surgery, Dermatology, Skin and Laser

San Diego, California, 92121, United States

Location

Study Officials

• Toni Fournier

  ThermiGen, LLC

  STUDY DIRECTOR

• Kevin O'Brien

  ThermiGen, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: April 11, 2017
• Study Start: December 8, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 6, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)