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Clinical Trial NCT07224880 for glp1 Agonist, Gene Expression, Skin Laxity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists 10
Clinical Trial NCT07224880 is an observational study for glp1 Agonist, Gene Expression, Skin Laxity that is recruiting. It started on October 14, 2025 with plans to enroll 10 participants. Led by Cytrellis Biosystems, Inc., it is expected to complete by February 28, 2026. The latest data from ClinicalTrials.gov was last updated on December 31, 2025.
Brief 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 a...Show More
Detailed Description
This device has been approved for sale by the United States Food and Administration (FDA) for use in treatment of moderate and severe wrinkles in the mid and lower face. This device is not currently approved by the FDA for use in other locations or for other indications. The study device uses specially designed hollow coring needles, that when inserted in the tissue remove cores the size of the needle inner diameter....Show More
Official Title
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
Conditions
glp1 AgonistGene ExpressionSkin LaxityPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- TP-00457
NCT ID Number
Start Date (Actual)
2025-10-14
Last Update Posted
2025-12-31
Completion Date (Estimated)
2026-02-28
Enrollment (Estimated)
10
Study Type
Observational
Status
Recruiting
Keywords
ellacor
GLP-1
weight loss
GLP-1
weight loss
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
GLP1 Patients Patients have lost at least 10% of their baseline body weight from taking a GLP-1 receptor agonist | ellacor dermal non-thermal micro-coring device |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Safety and Outcomes | Safety and Efficacy of ellacor treatment in participants with FST I-VI, inclusive of participants following treatment with GLP-1 RA
There will be follow-up appointments after the initial screening and enrollment visit. Each of the assessments at follow up days are specified below:
Baseline or Day 0 Day 3 Day 7 Day 30 through study completion, up to Day 90 | study time frame |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
- 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
- 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
- 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
- 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
- Patients with scars less than six (6) months old in the treatment area
Cytrellis Biosystems, Inc.Study Central Contact
Contact: Karyn Siemasko, PhD, 949-394-0585, [email protected]
Contact: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 Study Locations in 1 Countries
California
Tri Valley Plastic Surgery, Dublin, California, 94568, United States
Pooja Kachhia, Contact, 925-701-9302, [email protected]
McKenzie Dixon, Contact, 925-701-9302, [email protected]
Steven Williams, MD, Principal Investigator
Recruiting