Mechanical Coring to Achieve Directional Skin Tightening
United States70 participantsStarted 2021-02-14
Plain-language summary
The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
Who can participate
Age range
30 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 or female subjects between 30 and 70 years of age.
. Able to read, understand, and voluntarily provide written Informed Consent.
. Able and willing to comply with the treatment/follow-up schedule and requirements.
. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.
Exclusion criteria
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.
What they're measuring
1
Percentage of Cores Successfully Removed by Coring Device
. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
. History of keloid formation
. Active smoker or having quit smoking in the last 3 months.
. Active, chronic, or recurrent infection
. Compromised immune and/or healing system (e.g. diabetes)
. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.