Recruiting

GLP-1's

Sponsor:

Cytrellis Biosystems, Inc.

Code:

NCT07224880

Conditions

glp1 Agonist

Gene Expression

Skin Laxity

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

ellacor

Study Details

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 also evaluate side effects that occur with this treatment, if any. Standardized 2D Imaging will be used to quantify reduction of wrinkle severity

Conditions

glp1 Agonist

Gene Expression

Skin Laxity

Study ID

NCT07224880

Start date

Oct 14, 2025

Status verified date

Sep, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Jan 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

GLP1 Patients

Patients have lost at least 10% of their baseline body weight from taking a GLP-1 receptor agonist

Interventions

ellacor

dermal non-thermal micro-coring device

Primary outcome measure

  • Safety and Outcomes [ Time Frame: study time frame ]

Central Contacts and Locations

Central contacts

Locations

Tri Valley Plastic Surgery

Recruiting

Dublin, California, United States, 94568

Contacts

Principal Investigator:

Steven Williams, MD

More Information

Sponsor

Cytrellis Biosystems, Inc.

Last update posted

Dec 31, 2025

Last verified

Sep, 2025

Keywords

  • ellacor
  • GLP-1
  • weight loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cytrellis Biosystems, Inc. on 2025-12-31.