Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments
8 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Illinois
-
Naperville, Illinois, États-Unis, 60563
- Oak Dermatology
-
-
Maryland
-
Hunt Valley, Maryland, États-Unis, 21030
- Maryland Dermatology Laser, Skin, & Vein Institute, LLC
-
-
New Jersey
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Montclair, New Jersey, États-Unis, 07042
- New Jersey Plastic Surgery
-
-
Pennsylvania
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Devon, Pennsylvania, États-Unis, 19333
- Laser & Skin Surgery Center of Pennsylvania
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: XERF Treatment
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate
Délai: 90 days after the final treatment
|
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.
|
90 days after the final treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Satisfaction Score (PSS) Responder Rate
Délai: 30 and 90 days after the final treatment
|
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.
|
30 and 90 days after the final treatment
|
|
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate at 30 Days
Délai: 30 days after the final treatment
|
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.
|
30 days after the final treatment
|
|
Incidence of Adverse Events
Délai: From first treatment through 90 days after the final treatment
|
Number and proportion of participants experiencing treatment-emergent adverse events, documented throughout the study and follow-up.
|
From first treatment through 90 days after the final treatment
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 janvier 2025
Achèvement primaire (Réel)
12 août 2025
Achèvement de l'étude (Réel)
12 août 2025
Dates d'inscription aux études
Première soumission
5 février 2026
Première soumission répondant aux critères de contrôle qualité
8 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- LMP24001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .