Safety and Effects of Ellacor Micro-Coring Technology for Moderate to Severe Facial Wrinkles in Adults Aged 30-65 Including Patients Using Glucagon-Like Peptide-1 Receptor Agonists Across Skin Types I-VI

What this Trial Is About

Researchers are evaluating the Ellacor4 Micro-Coring Technology4 device in people with Fitzpatrick Skin Types I through VI, including those taking GLP-1 receptor agonists, a type of medication that helps control blood sugar and supports weight loss. The study aims to understand how the device works on different skin types and treatment areas, and to observe any changes in treated skin compared to untreated skin. Side effects related to this treatment will also be monitored. Wrinkle severity reduction will be measured using standardized 2D imaging techniques. The device uses hollow coring needles to remove tiny, full-thickness skin cores about 0.4 millimeters wide, which is larger than standard microneedling that only punctures without removing tissue. The skin removal is small enough to avoid visible scarring. After treatment, the skin repairs itself by producing new collagen and elastin fibers. Participants will receive the same number of Ellacor4 treatments during the study, which lasts up to 90 days. Study visits include an initial screening and enrollment visit, one treatment visit, and four follow-up visits on Days 3, 7, 30, and 90, with an optional additional follow-up if needed. Participants will attend at least six visits lasting 30 to 90 minutes each. Assessments include imaging to quantify wrinkle reduction and monitoring for safety and side effects. Participation ends after the Day 90 follow-up. The study will include 10 to 30 people, all treated at one center. Participants may have their screening and treatment visits on the same day, with total study involvement lasting about three months.

Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists