CompletedNot Applicable

Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

United States15 participantsStarted 2020-10-01

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy male and female adults between ages 21-70 years of age. * Desire skin laxity lift of the submental region. * Confirmed BMI ≤ 35. * Subjects who can read, understand, and sign the Informed Consent Form. * Subjects willing and able to comply with all study requirements. * Fitzpatrick skin type I-VI. * Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale * Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study. Exclusion Criteria: * Active localized or systemic infections, that may alter wound healing. * Immunocompromised subjects. * Subjects with coagulation disorder. * History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). * Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). * Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4, Appendix E), or other anatomical feature for which reduction in SMF which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome. * Scarring in areas to be treated. * Tattoos in the treatment areas to be treated. * Significant open facial wounds or lesions. * Severe or cystic acne in treatment areas. * Current active smoker. * Use of Accutane (Isotretinoin) within the past 6 mont…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.