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

招募中
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临床试验NCT07224880是一项针对glp1 Agonist，Gene Expression，皮肤松弛的观察研究试验，目前试验状态为招募中。试验始于2025年10月14日，计划招募10名患者。该研究由Cytrellis Biosystems, Inc.主导，预计于2026年2月28日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月31日。
简要概括
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...显示更多
详细描述
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....显示更多
官方标题

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

疾病
glp1 AgonistGene Expression皮肤松弛
出版物
关于此临床试验发表的科学文章和研究论文：
其他研究标识符
  • TP-00457
NCT编号
NCT07224880
实际开始日期
2025-10-14
最近更新发布
2025-12-31
预计完成日期
2026-02-28
计划入组人数
10
研究类型
观察研究
试验状态
招募中
关键词
ellacor
GLP-1
weight loss
试验组/干预措施
参与者组/试验组干预措施/治疗方法
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
主要终点
结果指标度量标准描述时间框架
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
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
30 Years
适龄性别
全部
  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.
研究中心联系人
联系人: Karyn Siemasko, PhD, 949-394-0585, [email protected]
联系人: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 位于 1 个国家/地区的研究中心

California

Tri Valley Plastic Surgery, Dublin, California, 94568, United States
Pooja Kachhia, 联系人, 925-701-9302, [email protected]
McKenzie Dixon, 联系人, 925-701-9302, [email protected]
Steven Williams, MD, 主要研究者
招募中