Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments
2026年5月8日 更新者：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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Illinois
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Naperville、Illinois、アメリカ、60563
- Oak Dermatology
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Maryland
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Hunt Valley、Maryland、アメリカ、21030
- Maryland Dermatology Laser, Skin, & Vein Institute, LLC
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New Jersey
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Montclair、New Jersey、アメリカ、07042
- New Jersey Plastic Surgery
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Pennsylvania
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Devon、Pennsylvania、アメリカ、19333
- Laser & Skin Surgery Center of Pennsylvania
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Satisfaction Score (PSS) Responder Rate
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年1月20日
一次修了 (実際)
2025年8月12日
研究の完了 (実際)
2025年8月12日
試験登録日
最初に提出
2026年2月5日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- LMP24001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
顔の皮膚のたるみの臨床試験
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Duke UniversityNational Institute of Mental Health (NIMH); University of Pittsburgh; Harvard University完了