임상 레이더 AI | ||
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임상시험 NCT07224880은(는) glp1 Agonist, Gene Expression, 피부 탄력 저하에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Ellacor® Micro-Coring Technology® in Fitzpatrick Skin Types I-VI, Including Patients Receiving Glucagon-Like Peptide-1 Receptor Agonists 10
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07224880은(는) glp1 Agonist, Gene Expression, 피부 탄력 저하에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2025년 10월 14일에 시작되어 10명의 참여자를 모집하고 있습니다. Cytrellis Biosystems, Inc.이(가) 진행하며, 2026년 2월 28일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 31일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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....더 보기
공식 제목
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
질환명
glp1 AgonistGene Expression피부 탄력 저하출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- TP-00457
NCT 번호
실제 연구 시작일
2025-10-14
최신 업데이트 게시
2025-12-31
예상 연구 완료일
2026-02-28
계획된 등록 인원
10
연구종류
관찰연구
상태
모집중
키워드
ellacor
GLP-1
weight loss
GLP-1
weight loss
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
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 |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
30 Years
참여 가능한 성별
전체
- 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.연구 대표 연락처
연락처: Karyn Siemasko, PhD, 949-394-0585, [email protected]
연락처: Delia Khayat, PharmD, 305-484-4948, [email protected]
1 1개국에 임상시험 장소
California
Tri Valley Plastic Surgery, Dublin, California, 94568, United States
Pooja Kachhia, 연락처, 925-701-9302, [email protected]
McKenzie Dixon, 연락처, 925-701-9302, [email protected]
Steven Williams, MD, 책임연구자
모집중