Skin LaxityNCT02832674
Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
A study testing Percutaneous Radiofrequency single treatment in people with Skin Laxity, run by ThermiGen, LLC at 1 site in United States.
Trial summary
A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Percutaneous Radiofrequency single treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2016to 8 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between the age of 35 and 65 inclusive;
- Mild to Moderate Skin Laxity Severity on the submental area defined as: "normal" muscle, "mild to moderate" skin laxity and "mild to moderate" fat;
- Desire to improve jawline definitions and/or submental skin lift
- Body mass index (BMI) ≤30;
- 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.
Who cannot join
- Excessive subcutaneous fat on the submental area
- Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, 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);
- History of cosmetic treatments on the face and neck including but not limited to: facial skin tightening procedures within the past year, injectable fillers of any type, Botox on the lower face, ablative resurfacing laser treatment, none ablative, rejuvenative laser or light treatment within the past six months, deep facial peels, dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or other.
- History or current injury to the Head and Neck.
- Severe solar elastosis
- Clinically significant facial wounds, lesions or acute infections including cystic acne, dermatitis, lupus or other immunodeficiency affecting the dermis
Show all 19Show fewer
- Presence of metal stents or facial implants
- Pregnant or planning pregnancy prior to the end of study participation
- Current or past history of smoking
- History or current diagnosis of cancer of any type
- History of uncontrolled cardiovascular disease(i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- Known hypersensitivity to local anesthetic medications
- History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants
- Possesses a surgically implanted electronic device (i.e. pacemaker)
- 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
- A family member of the investigator 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
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
About this study
Official title: An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift
A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits.
All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters.
Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.
Read the detailed description
This is an open-label, single-center, single-treatment prospective evaluation of the ThermiRF device in the treatment of submental skin laxity. The purpose of this prospective study is to determine the effectiveness and safety of the ThermiRF device in achieving overall submental lift.
In this study, "Lift" is defined as a ≥ 20 mm2 lift of the submental area after the ThermiRF treatment.
A total of 70 male and female healthy volunteers between the age of 35 and 65 will be considered for this study. Subjects who sign the informed consent form and meet all entry criteria will be enrolled in this study and will be assigned a unique number/code to preserve confidentiality.
A total of six study visits are planned as described below:
- Visit 1: Screening visit - (Day 1)
- Visit 2: Single Treatment visit
- Visit 3: Day 30 safety assessment (± 7 to 14 days)
- Visit 4: Day 60 safety and Image capture for validation exercise (± 7 to 14 days)
- Visit 5: Day 90 safety and effectiveness follow-up visit (± 7 to 14 days)
- Visit 6: Day 180 safety and effectiveness follow-up visit - (± 7 to 14 days)
Photo images (2D and 3D) will be collected at Visits 1, Visit 4 (on first 30 subjects only), and at Visits 5 and 6 using a standard camera (2D) and the Vectra system (3D). The purpose of the photos are to quantitatively and qualitative evaluate treatment effectiveness using objective and subjective assessments to measure physical changes to the skin's microstructure and aesthetic skin features over time.
A skin elasticity assessment using the Cutomer will be collected at Visits 1 (screening), 5 (Day 90) and 6 (Day 180) to assess if any biomechanical changes of the skin occurred as a result of the ThermiRF treatment.
Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported).
The overall study duration is approximately 12 months (i.e., 5-6 month recruitment period and 6 month study visits).
- Conditions
- Skin Laxity
- Being tested
- Percutaneous Radiofrequency single treatment
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Radiofrequency single treatmentDevice
Also called Thermi Percutaneous Radiofrequency Treatment, Hunsted Infusion on the treatment area, Thermal Camera, Ice packs
Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment | Experimental | All enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment' Receives: Device: Percutaneous Radiofrequency single treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Lift at the Submental Area Measuring >/= 20 mm2
A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
Measured: Change from baseline at Day 90
Secondary outcomes (5)
Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Overall improvement of submental lift was determined by a blinded rater panel using before and after photos
Measured: Change from baseline to Days 90 and 180
Physician Global Aesthetic Improvement Scale (P-GAIS)
A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from "Very much improved" to "worse".
Measured: Change from baseline at Days 90 and 180
Subject Global Aesthetic Improvement Scale (S-GAIS)
A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to "lift"is measured from. the 5-point scale measures from Very much improved to worse.
Measured: Change from baseline at Days 90 and 180
Physician Global Satisfaction Questionnaire (P-GSQ)
A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.
Measured: Change from baseline at Days 90 and 180
Subject Global Satisfaction Questionnaire (S-GSQ)
A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.
Measured: Change from baseline at Days 90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start25 Jun 2016
- Primary completion20 Feb 2017
- Study completion8 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin LaxityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThermiGen, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry DiBernardo, MD, Principal investigator, New Jersey Plastic SurgeryToni Fournier, Study director, ThermiGen, LLCKevin O'Brien, Study chair, ThermiGen, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832674
- Sponsor's protocol ID
- THERMI_0005
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2016
- Last updated
- 1 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift
- ClinicalTrials.gov ID
- NCT02832674
- Acronym / sponsor ID
- THERMI_0005
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ThermiGen, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2016 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 8 Apr 2017 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits.
All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters.
Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.
Detailed description
This is an open-label, single-center, single-treatment prospective evaluation of the ThermiRF device in the treatment of submental skin laxity. The purpose of this prospective study is to determine the effectiveness and safety of the ThermiRF device in achieving overall submental lift.
In this study, "Lift" is defined as a ≥ 20 mm2 lift of the submental area after the ThermiRF treatment.
A total of 70 male and female healthy volunteers between the age of 35 and 65 will be considered for this study. Subjects who sign the informed consent form and meet all entry criteria will be enrolled in this study and will be assigned a unique number/code to preserve confidentiality.
A total of six study visits are planned as described below:
- Visit 1: Screening visit - (Day 1)
- Visit 2: Single Treatment visit
- Visit 3: Day 30 safety assessment (± 7 to 14 days)
- Visit 4: Day 60 safety and Image capture for validation exercise (± 7 to 14 days)
- Visit 5: Day 90 safety and effectiveness follow-up visit (± 7 to 14 days)
- Visit 6: Day 180 safety and effectiveness follow-up visit - (± 7 to 14 days)
Photo images (2D and 3D) will be collected at Visits 1, Visit 4 (on first 30 subjects only), and at Visits 5 and 6 using a standard camera (2D) and the Vectra system (3D). The purpose of the photos are to quantitatively and qualitative evaluate treatment effectiveness using objective and subjective assessments to measure physical changes to the skin's microstructure and aesthetic skin features over time.
A skin elasticity assessment using the Cutomer will be collected at Visits 1 (screening), 5 (Day 90) and 6 (Day 180) to assess if any biomechanical changes of the skin occurred as a result of the ThermiRF treatment.
Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported).
The overall study duration is approximately 12 months (i.e., 5-6 month recruitment period and 6 month study visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Treatment | Experimental | Device: Percutaneous Radiofrequency single treatmentAll enrolled subjects will receive a Percutaneous Radiofrequency Single Treatment' |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female between the age of 35 and 65 inclusive;
- Mild to Moderate Skin Laxity Severity on the submental area defined as: "normal" muscle, "mild to moderate" skin laxity and "mild to moderate" fat;
- Desire to improve jawline definitions and/or submental skin lift
- Body mass index (BMI) ≤30;
- Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
Key exclusion criteria (19 listed)
- Excessive subcutaneous fat on the submental area
- Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, 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);
- History of cosmetic treatments on the face and neck including but not limited to: facial skin tightening procedures within the past year, injectable fillers of any type, Botox on the lower face, ablative resurfacing laser treatment, none ablative, rejuvenative laser or light treatment within the past six months, deep facial peels, dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or other.
- History or current injury to the Head and Neck.
- Severe solar elastosis
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 |
|---|---|---|
| Percutaneous Radiofrequency single treatmentAlso: Thermi Percutaneous Radiofrequency Treatment, Hunsted Infusion on the treatment area, Thermal Camera, Ice packsPercutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold. | Device | Single Treatment |
Primary outcome
Tissue Lift at the Submental Area Measuring >/= 20 mm2
Time frame: Change from baseline at Day 90
A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).
5 secondary outcomes
Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer
Time frame: Change from baseline to Days 90 and 180
Physician Global Aesthetic Improvement Scale (P-GAIS)
Time frame: Change from baseline at Days 90 and 180
Subject Global Aesthetic Improvement Scale (S-GAIS)
Time frame: Change from baseline at Days 90 and 180
Physician Global Satisfaction Questionnaire (P-GSQ)
Time frame: Change from baseline at Days 90 and 180
Subject Global Satisfaction Questionnaire (S-GSQ)
Time frame: Change from baseline at Days 90 and 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Barry DiBernardo, MD principal investigator
New Jersey Plastic Surgery
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 Percutaneous Radiofrequency single treatment in people with Skin Laxity, 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 8 inclusion and 19 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 1 May 2018. 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?
Yes. Results are posted in the registry (first posted 1 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tissue Lift at the Submental Area Measuring >/= 20 mm2 (time frame: Change from baseline at Day 90). 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 1 May 2018.