The main purpose of the study is to collect information about how the device functions in a variety of treatment areas and skin types and to find out what changes, if any, occur in the skin treated with the study device compared to the skin that wasn't treated including patients receiving GLP-1's, a class of medications that mimic a natural hormone to help control blood sugar and support weight loss. The study will also evaluate side effects that occur with this treatment, if any. Standardized 2D Imaging will be used to quantify reduction of wrinkle severity
Male and female adult, between the ages of 30 and 65
Fitzpatrick Skin Type I-VI
Have moderate to severe wrinkles on the mid and lower face, according to Lemperle Wrinkle Severity Scale (LWSS), i.e. score 3, 4 or 5.
Have moderate to extreme abdominal laxity according to Stokes Scale (i.e., score of 2-4 on a scale of 0-4).
Pregnant women or nursing mothers
Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
Patients with a history or presence of any clinically significant bleeding disorder
The study population consists of adult male and female participants aged between 30 to 65 years, with FST I-VI, with moderate to severe mid to lower face wrinkles and/or abdominal skin laxity as a result of excessive weight loss. They have chosen to participate in this study as evidenced by execution of the informed consent document.
Other
Prospective
ellacor
Devicedermal non-thermal micro-coring device
Safety and Outcomes
Safety and Efficacy of ellacor treatment in participants with FST I-VI, inclusive of participants following treatment with GLP-1 RA There will be follow-up appointments after the initial screening and enrollment visit. Each of the assessments at follow up days are specified below: Baseline or Day 0 Day 3 Day 7 Day 30 through study completion, up to Day 90
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