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Trial record 26 of 166 for:    "Sweat Gland Disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03107065
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
ThermiGen, LLC

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.


Condition or disease Intervention/treatment Phase
Sweating Increased Armpits Device: Thermi Radiofrequency Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 8, 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) improvement post treatment [ Time Frame: Day 60 ]
    subjective improvement from initial to post questionnaire on the DLQI


Other Outcome Measures:
  1. Odor Scale (OS) Improvement post treatment [ Time Frame: Day 60 and Day 90 ]
    subjective improvement from initial to post questionnaire on the OS

  2. Reduction of excessive sweating [ Time Frame: Day 60 ]
    Reduction of 1-point improvement on the HDSS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107065


Locations
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United States, California
Faces+ Plastic Surgery, Dermatology, Skin and Laser
San Diego, California, United States, 92121
Sponsors and Collaborators
ThermiGen, LLC
Investigators
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Study Director: Toni Fournier ThermiGen, LLC
Study Chair: Kevin O'Brien ThermiGen, LLC

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Responsible Party: ThermiGen, LLC
ClinicalTrials.gov Identifier: NCT03107065     History of Changes
Other Study ID Numbers: THERMI_0007
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ThermiGen, LLC:
Sweating

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases