Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Gl… (NCT07224880) | Clinical Trial Compass
RecruitingNot Applicable
Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists
United States10 participantsStarted 2025-10-14
Plain-language 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
Who can participate
Age range30 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Willingness to sign Informed Consent Form
Exclusion criteria
✕. 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
✕. 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
✕. Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection)
✕. 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
✕. Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area