رادار التجارب AI | ||
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حالة التجربة السريرية NCT07224880 لـ glp1 Agonist، Gene Expression، ترهل الجلد هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists ١٠
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07224880 هي دراسة رصدية لـglp1 Agonist، Gene Expression، ترهل الجلد وهي يقبل مشاركين. بدأت في ٢٢ ربيع الآخر ١٤٤٧ هـ مع خطة لتجنيد ١٠ مشاركًا. يقودها Cytrellis Biosystems, Inc.، ومن المتوقع اكتمالها بحلول ١١ رمضان ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١١ رجب ١٤٤٧ هـ.
الملخص
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...عرض المزيد
وصف مفصل
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....عرض المزيد
العنوان الرسمي
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
الحالات الطبية
glp1 AgonistGene Expressionترهل الجلدالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- TP-00457
NCT معرّف
تاريخ البدء (فعلي)
2025-10-14
آخر تحديث مُنشور
2025-12-31
تاريخ الاكتمال (المقدر)
2026-02-28
عدد المشاركين المخطط لهم
١٠
نوع الدراسة
رصدية
الحالة
يقبل مشاركين
الكلمات الرئيسية
ellacor
GLP-1
weight loss
GLP-1
weight loss
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
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 |
النتيجة الرئيسية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
30 Years
الجنس المؤهل
الكل
- 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
- 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
Cytrellis Biosystems, Inc.جهة اتصال مركزية للدراسة
جهة اتصال: Karyn Siemasko, PhD, 949-394-0585, [email protected]
جهة اتصال: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 مواقع الدراسة في 1 بلدان
California
Tri Valley Plastic Surgery, Dublin, California, 94568, United States
Pooja Kachhia, جهة اتصال, 925-701-9302, [email protected]
McKenzie Dixon, جهة اتصال, 925-701-9302, [email protected]
Steven Williams, MD, المحقق الرئيسي
يقبل مشاركين