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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-65
SponsorCytrellis Biosystems, Inc.

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators