Ellacor micro-coring for facial wrinkles and abdominal skin laxity across all Fitzpatrick skin types, including people on GLP-1 medications.

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

This study will test whether Ellacor micro-coring improves moderate-to-severe mid and lower face wrinkles and abdominal laxity in adults 30–65, including those taking GLP-1 medications.

Quick facts

• Study type: Observational
• Enrollment: 10 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Cytrellis Biosystems, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Dublin, California)
• Trial ID: NCT07224880 on ClinicalTrials.gov

What this trial studies

A single-center observational study will enroll 10–30 adults aged 30–65 who have moderate-to-severe mid and lower face wrinkles and moderate-to-extreme abdominal laxity and treat each participant with the same number of Ellacor micro-coring procedures. Participants will be followed for up to 90 days with a minimum of six visits, using standardized 2D imaging to quantify changes in wrinkle severity between treated and untreated skin. The protocol includes people with Fitzpatrick skin types I–VI and specifically includes those receiving GLP‑1 receptor agonists to document any differences in response or healing. Investigators will record adverse events and tissue repair outcomes to characterize device performance in treatment areas and patient subgroups beyond the device’s original FDA-cleared indication.

Who should consider this trial

Good fit: Adults 30–65 with Fitzpatrick skin types I–VI who have moderate-to-severe mid/lower face wrinkles (Lemperle score 3–5) and moderate-to-extreme abdominal laxity (Stokes score 2–4) and who can attend multiple in-person visits and consent to the procedure.

Not a fit: Pregnant or nursing people, those with open wounds or active skin disease in the treatment area, people with significant bleeding disorders, allergies to procedure materials, or certain dermatologic/autoimmune conditions are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide a minimally invasive option to reduce facial wrinkles and improve abdominal skin laxity, including for patients using GLP‑1 medications.

How similar studies have performed: Ellacor micro-coring has FDA clearance for moderate-to-severe mid and lower face wrinkles, indicating prior success for that indication, but its use on other body areas and specifically in patients on GLP‑1 therapies is less well studied.

Eligibility criteria

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 topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
4. Patients with a history or presence of any clinically significant bleeding disorder
5. Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus
6. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection)
7. Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days
8. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area
9. Patients with have undergone plastic surgery of the face within the last twelve (12) months or have any facial surgical scars less than twelve (12) months old
10. Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months
11. Patients with scars less than six (6) months old in the treatment area

Where this trial is running

Dublin, California

• Tri Valley Plastic Surgery — Dublin, California, United States (Recruiting)

Study contacts

• Study coordinator: Karyn Siemasko, PhD

Conditions glp1 Agonist; Gene Expression; Skin Laxity; ellacor; GLP-1; weight loss