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

December 18, 2017 updated by: ThermiGen, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Faces+ Plastic Surgery, Dermatology, Skin and Laser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: single treatment
Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands
Device: Thermi Radiofrequency
Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dermatology Life Quality Index (DLQI) improvement post treatment
Time Frame: Day 60
subjective improvement from initial to post questionnaire on the DLQI
Day 60

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Odor Scale (OS) Improvement post treatment
Time Frame: Day 60 and Day 90
subjective improvement from initial to post questionnaire on the OS
Day 60 and Day 90
Reduction of excessive sweating
Time Frame: Day 60
Reduction of 1-point improvement on the HDSS
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ThermiGen, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Toni Fournier, ThermiGen, LLC
  • Study Chair: Kevin O'Brien, ThermiGen, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THERMI_0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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