What this trial means for you
This study is recruiting now at 1 US site. It's studying see the official record for glp1 agonist, gene expression, skin laxity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
California
- Tri Valley Plastic Surgery — Dublin · Recruiting now
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.
Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in
.env to activate this form.)