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

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07224880 est une étude observationnel pour glp1 Agonist, Gene Expression, Laxité cutanée. Son statut actuel est : en recrutement. L'étude a débuté le 14 octobre 2025 et vise à recruter 10 participants. Dirigée par Cytrellis Biosystems, Inc., l'étude devrait être terminée d'ici le 28 février 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 31 décembre 2025.
Résumé succinct
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...Afficher plus
Description détaillée
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....Afficher plus
Titre officiel

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

Pathologies
glp1 AgonistGene ExpressionLaxité cutanée
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • TP-00457
Numéro NCT
NCT07224880
Date de début (réel)
2025-10-14
Dernière mise à jour publiée
2025-12-31
Date de fin (estimée)
2026-02-28
Inscription (estimée)
10
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
ellacor
GLP-1
weight loss
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
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
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
30 Years
Sexes éligibles
Tous
  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.
Contact central de l'étude
Contact: Karyn Siemasko, PhD, 949-394-0585, [email protected]
Contact: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 Centres de l'étude dans 1 pays

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, Investigateur principal
En recrutement