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

NCT07224880 | Recruiting FDA Device

• 1 other identifier: TP-00457
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

ellacor; GLP-1; weight loss

Outcome Measures

Primary Outcomes (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

  study time frame

Study Arms (1)

GLP1 Patients

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

Device: ellacor

Interventions

ellacor DEVICE

dermal non-thermal micro-coring device

Also known as: micro-coring, dermal micro-coring

GLP1 Patients

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytrellis Biosystems, Inc.: lead

Study Sites (1)

Tri Valley Plastic Surgery

Dublin, California, 94568, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 38841534 BACKGROUND

• 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.

  PMID: 36262685 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Extracted cores may be retained in the tubing.

MeSH Terms

Conditions

Cutis Laxa; Weight Loss

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Karyn Siemasko, PhD

CONTACT

949-394-0585; ksiemasko@cytrellis.com

Delia Khayat, PharmD

CONTACT

305-484-4948; dkhayat@cytrellis.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 5, 2025
• Study Start: October 14, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)