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glp1 AgonistNCT07224880

Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists

An observational study of glp1 Agonist and Gene Expression, run by Cytrellis Biosystems, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
glp1 Agonist, Gene Expression, Skin Laxity
What is being tested?
ellacor
Type of treatment
Medical device
How many people
9 participants
Where
1 siteUnited States
Study dates
14 Oct 2025to 21 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of adult male and female participants aged between 30 to 65 years, with FST I-VI, with moderate to severe mid to lower face wrinkles and/or abdominal skin laxity as a result of excessive weight loss. They have chosen to participate in this study as evidenced by execution of the informed consent document.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tri Valley Plastic Surgery

    Dublin, California, 94568

Other trials in United States

About this study

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

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

Read the 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. The tissue cores are then removed from the needle and pulled out by suction. Compared to micro-needling procedures that only puncture the skin without removing any tissue, the ellacor Micro-Coring procedure needle removes full thickness cores of skin with diameters in the range of 400 microns (0.4 millimeters or about 4 times as wide as a human hair). Skin that is removed with the ellacor Micro-Coring Technology is below the size limit that causes visible scar formation. After study treatment with the MicroCoring Technology, the areas undergo a process of repair including the formation of new collagen and elastin fibers that are typical of healthy tissue.

A minimum of 10 and maximum of 30 people will participate in this study at Tri Valley Plastic Surgery. Tri Valley Plastic Surgery is the only center participating in this study. Each person in this study will receive the same number of ellacor® treatments The study will last up to 3 months (90 days) for each person participating. There will be a minimum of 6 study visits: a Screening \& Enrollment Visit followed by 1 ellacor treatment visit and 4 followup visits (Day 3, Day 7, Day 30, and Day 90); there may be an addition follow-up visit as needed according to you and your doctor. Each visit is estimated to take 30 to 90 minutes. Your participation in the study ends on the Day 90 follow-up visit. Your screening visit and your first ellacor treatment visit could occur on the same day. If this happens then your participation in the study will be about 3 months (90 days).

Being tested
ellacor
Keywords
ellacor, GLP-1, weight loss
Medical subject headings
Cutis Laxa, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ellacorDevice

    Also called micro-coring, dermal micro-coring

    dermal non-thermal micro-coring device

Study groups in NCT07224880
Study groupRoleWhat they receive
GLP1 PatientsPatients have lost at least 10% of their baseline body weight from taking a GLP-1 receptor agonist
Receives: Device: ellacor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: study time frame

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2025
  2. Study start14 Oct 2025
  3. Primary completion21 Aug 2026
  4. Study completion21 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224880
Sponsor's protocol ID
TP-00457
Status last verified
Sep 2025
First submitted
29 Oct 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Subedi SK, Ganor O. Considerations for the Use of Fitzpatrick Skin Type in Plastic Surgery Research. Plast Reconstr Surg Glob Open. 2024 Jun 5;12(6):e5866. doi: 10.1097/GOX.0000000000005866. eCollection 2024 Jun. No abstract available.

    PubMed 38841534

  • Gfrerer L, Kilmer SL, Waibel JS, Geronemus RG, Biesman BS. Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles. Plast Reconstr Surg Glob Open. 2022 Oct 17;10(10):e4547. doi: 10.1097/GOX.0000000000004547. eCollection 2022 Oct.

    PubMed 36262685

Questions about this trial

What is this clinical trial studying?

An observational study of glp1 Agonist and Gene Expression, run by Cytrellis Biosystems, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Outcomes (time frame: study time frame). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224880, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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