Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments
2026년 5월 8일 업데이트: CynosureLutronic
Safety and Efficacy Evaluation of the XERF Device for Aesthetic Treatments
The goal of this clinical study is to evaluate the safety and clinical effectiveness of the XERF noninvasive dual-frequency monopolar radiofrequency device for aesthetic improvement of facial aging, including fine lines and wrinkles, eyebrow lifting, and tightening of lax tissue in the lower face, submental area, and neck in healthy adults.
Up to 60 participants may be enrolled across up to five clinical sites in the United States. Participants receive XERF treatments using 6.78 MHz and 2.0 MHz energy; most undergo two sessions approximately four weeks apart (the protocol allows up to three). Standardized photographs are taken at baseline and follow-up visits.
Outcomes are assessed approximately 30 and 90 days after the final treatment. Effectiveness is evaluated using investigator-assessed global aesthetic improvement and participant-reported satisfaction, while safety and tolerability are assessed through procedural pain ratings and monitoring of adverse events throughout the study.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Illinois
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Naperville, Illinois, 미국, 60563
- Oak Dermatology
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Maryland
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Hunt Valley, Maryland, 미국, 21030
- Maryland Dermatology Laser, Skin, & Vein Institute, LLC
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New Jersey
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Montclair, New Jersey, 미국, 07042
- New Jersey Plastic Surgery
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Pennsylvania
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Devon, Pennsylvania, 미국, 19333
- Laser & Skin Surgery Center of Pennsylvania
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- 22 - 70 years old
- Is willing to undergo study device use.
- Has not received any toxin/filler in the treatment area in the past 6 months and agrees to not receive any throughout the study.
- Willing to maintain current diet and exercise routine throughout study duration.
- Understands and accepts the study condition to not receive any other procedures to the treatment area or to undergo any procedures, take any medications, supplements, or partake in any treatments indicated for weight loss or body contouring throughout the length of the study.
- Understands and accepts the study condition of and agrees that he or she is able to be present for all study visits.
- Willing to comply with all requirements of the study and is able to provide written informed consent.
Exclusion Criteria:
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding, or planning a pregnancy during the study period.
- Has an implanted pacemaker, internal ventricular fibrillation controller (AICD), or any electrical device.
- Has a metal implant that interferes with the transmission of energy to the electrical field.
- Has received permanent fillers or facial implants.
- Has a detected pathological abnormality.
- Has a medical condition with potentially decreased function of the peripheral nervous tissue, such as but not limited to diabetes or multiple sclerosis.
- Has an infection or infected tissue in the treatment area.
- Unable or not willing to follow instructions for pre- and post-treatment care
- Recent history of smoking (1 month)
- Has unrealistic treatment expectations.
- Has a history of herpes simplex in which the patient is not willing/able to receive preventive antiviral therapy.
- Has a blood disorder and taking aspirin or blood disorder medications.
- Has a malignant disease, cancer, or uncontrolled autoimmune disease.
- Had previous surgical or cosmetic procedures in the treatment area in the last 3 months that could interfere with the treatment procedure (including but not limited to dermabrasion, chemical peels, laser skin resurfacing, fat augmentations, topical retinoids and radiofrequency treatments)
- Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months prior to entering this study
- Has any condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: XERF Treatment
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Participants received treatment with a noninvasive contact monopolar radiofrequency (RF) device (XERF) operating at 6.78 MHz and 2.0 MHz.
The device delivers RF energy using depth-dependent settings (Shallow, Middle, and Deep) selected based on the target condition and facial anatomic zone.
Treatments were performed with the EFFECTOR 60 tip using sliding mode, stamping mode, or a combination, after facial cleansing and application of a thin film of ultrasound gel.
Adjustable cryogen gas cooling (ICD Levels 1-3) was used for epidermal protection and comfort; no topical anesthesia was used.
Participants underwent two treatment sessions approximately 4 weeks apart (the protocol allowed up to three sessions).
The number of shots and total energy delivered (joules) were recorded for each treatment area.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate
기간: 90 days after the final treatment
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Proportion of participants with a GAIS score ≥3 (on a 5-point scale, 1-5), assessed by site principal investigators using standardized clinical photographs.
A GAIS score ≥3 was considered an effective clinical improvement.
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90 days after the final treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction Score (PSS) Responder Rate
기간: 30 and 90 days after the final treatment
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Proportion of participants with a Patient Satisfaction Score (PSS) ≥4 on a 6-point scale (1 = extreme dissatisfaction; 6 = significant satisfaction), assessed at follow-up visits.
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30 and 90 days after the final treatment
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Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate at 30 Days
기간: 30 days after the final treatment
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Proportion of participants with a GAIS score ≥3 on a 5-point scale (1-5), assessed by site principal investigators using standardized clinical photographs.
GAIS ≥3 was considered effective improvement.
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30 days after the final treatment
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Incidence of Adverse Events
기간: From first treatment through 90 days after the final treatment
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Number and proportion of participants experiencing treatment-emergent adverse events, documented throughout the study and follow-up.
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From first treatment through 90 days after the final treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 1월 20일
기본 완료 (실제)
2025년 8월 12일
연구 완료 (실제)
2025년 8월 12일
연구 등록 날짜
최초 제출
2026년 2월 5일
QC 기준을 충족하는 최초 제출
2026년 5월 8일
처음 게시됨 (실제)
2026년 5월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 8일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LMP24001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
얼굴 피부 이완에 대한 임상 시험
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University Hospital, Strasbourg, France모병Cervico-Facial Surgery ENT 프랑스의 학술 의료 및 외과 교육 | Cervico-Facial Surgery ENT Medical 레지던트(Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine 및 Provence-Alpes-Côte d'Azur 지역)프랑스