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Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists
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
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
1
Enrollment
10
estimated
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Safety and Outcomes
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
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.
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
Endpoints (1)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other (unclassified)
1 endpointSafety and Outcomes
Time frame:study time frame
descriptive
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Plastic and reconstructive surgery. Global open2024 Jun (month)PMID38841534doi:10.1097/GOX.0000000000005866via CT.gov background
- Plastic and reconstructive surgery. Global open2022 Oct (month)PMID36262685doi:10.1097/GOX.0000000000004547via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.