Sweating Increased ArmpitsNCT03107065
Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue
A study testing Thermi Radiofrequency in people with Sweating Increased Armpits, run by ThermiGen, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sweating Increased Armpits
- What is being tested?
- Thermi Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2016to 6 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 22Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Faces+ Plastic Surgery, Dermatology, Skin and Laser
San Diego, California, 92121
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Sweating Increased Armpits
- Being tested
- Thermi Radiofrequency
- Keywords
- Sweating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermi RadiofrequencyDevice
Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation
| Study group | Role | What they receive |
|---|---|---|
| single treatment | Experimental | Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands Receives: Device: Thermi Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Life Quality Index (DLQI) improvement post treatment
subjective improvement from initial to post questionnaire on the DLQI
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start8 Dec 2016
- Primary completionJul 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sweating Increased ArmpitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermiGen, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toni Fournier, Study director, ThermiGen, LLCKevin O'Brien, Study chair, ThermiGen, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107065
- Sponsor's protocol ID
- THERMI_0007
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2016
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03107065
- Acronym / sponsor ID
- THERMI_0007
- Conditions
- Sweating Increased Armpits
- Keywords
- Sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ThermiGen, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single treatment | Experimental | Device: Thermi RadiofrequencyPercutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermi RadiofrequencyPercutaneous-Temperature Controlled-Radiofrequency Electrocoagulation | Device | single treatment |
Primary outcome
Dermatology Life Quality Index (DLQI) improvement post treatment
Time frame: Day 60
subjective improvement from initial to post questionnaire on the DLQI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Fournier study director
ThermiGen, LLC
Kevin O'Brien study chair
ThermiGen, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermi Radiofrequency in people with Sweating Increased Armpits, run by ThermiGen, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Life Quality Index (DLQI) improvement post treatment (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.