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Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists 10

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De klinische studie NCT07224880 is een observationeel studie bij glp1 Agonist, Gene Expression, Huidverslapping met de status rekruterend. Het doel is om 10 deelnemers te includeren vanaf 14 oktober 2025. De studie wordt geleid door Cytrellis Biosystems, Inc. en de voltooiing is gepland op 28 februari 2026. Laatste update op ClinicalTrials.gov: 31 december 2025.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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....Toon meer
Officiële titel

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

Aandoeningen
glp1 AgonistGene ExpressionHuidverslapping
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • TP-00457
NCT-ID
NCT07224880
Startdatum (Werkelijk)
2025-10-14
Laatste update geplaatst
2025-12-31
Verwachte einddatum
2026-02-28
Inschrijving (Geschat)
10
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
ellacor
GLP-1
weight loss
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
30 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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

  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
Cytrellis Biosystems, Inc. logoCytrellis Biosystems, Inc.
Centraal Contactpersoon
Contact: Karyn Siemasko, PhD, 949-394-0585, [email protected]
Contact: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 Studielocaties in 1 landen

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, Hoofdonderzoeker
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