Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift
Completed · Not applicable
Conditions studied: Skin Laxity
In brief
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.
Key facts
- Study ID
- NCT02832674
- Run by
- ThermiGen, LLC
- People needed
- 72
- Starts
- 2016-06-25
- Expected to finish
- 2017-04-08
- Last updated by the study team
- 2018-05-01
Who can join
Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- 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;
Where it is running
- New Jersey Plastic Surgery — Montclair, New Jersey, United States
Full record on ClinicalTrials.gov
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