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 range30 Years – 70 Years
SexALL
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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
✕. 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.
What they're measuring
1
Percentage of Cores Successfully Removed by Coring Device