Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

CynosureLutronic40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facial Aging Facial Skin Laxity Submental and Neck Skin Laxity

Interventions

Noninvasive dual-frequency monopolar radiofrequencyDEVICE

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.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Oak Dermatology

Naperville, Illinois, United States

Maryland Dermatology Laser, Skin, & Vein Institute, LLC

Hunt Valley, Maryland, United States

New Jersey Plastic Surgery

Montclair, New Jersey, United States

Laser & Skin Surgery Center of Pennsylvania

Devon, Pennsylvania, United States

Outcomes

Primary Outcomes

Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate

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.

Time frame: 90 days after the final treatment

Secondary Outcomes

Patient Satisfaction Score (PSS) Responder Rate

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.

Time frame: 30 and 90 days after the final treatment

Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate at 30 Days

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.

Time frame: 30 days after the final treatment

Incidence of Adverse Events

Number and proportion of participants experiencing treatment-emergent adverse events, documented throughout the study and follow-up.

Time frame: From first treatment through 90 days after the final treatment