About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- ellacor