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

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Устройство ellacor
  dermal non-thermal micro-coring device

Первичные конечные точки

• Safety and Outcomes [Срок оценки: study time frame]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Tri Valley Plastic Surgery — Dublin

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07224880 · TP-00457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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