Safety and Outcomes of Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs): A Case Series
Cytrellis Biosystems, Inc.
Summary
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
Description
This device has been approved for sale by the United States Food and Administration (FDA) for use in treatment of moderate and severe wrinkles in the mid and lower face. This device is not currently approved by the FDA for use in other locations or for other indications. The study device uses specially designed hollow coring needles, that when inserted in the tissue remove cores the size of the needle inner diameter. The tissue cores are then removed from the needle and pulled out by suction. Compared to micro-needling procedures that only puncture the skin without removing any tissue, the ell…
Eligibility
- Age range
- 30–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female adult, between the ages of 30 and 65 2. Fitzpatrick Skin Type I-VI 3. 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. 4. Have moderate to extreme abdominal laxity according to Stokes Scale (i.e., score of 2-4 on a scale of 0-4). 5. Willingness to sign Informed Consent Form Exclusion Criteria: 1. Pregnant women or nursing mothers 2. Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area 3. Patients with allergy to stainless steel or to t…
Interventions
- Deviceellacor
dermal non-thermal micro-coring device
Location
- Tri Valley Plastic SurgeryDublin, California