Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

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.

Study Overview

• Status: Completed
• Conditions: Facial Skin Laxity; Facial Aging; Submental and Neck Skin Laxity
• Intervention / Treatment: Device: Noninvasive dual-frequency monopolar radiofrequency

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Oak Dermatology
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Dermatology Laser, Skin, & Vein Institute, LLC
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery
  • Pennsylvania
    • Devon, Pennsylvania, United States, 19333
      • Laser & Skin Surgery Center of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: XERF Treatment

Device: Noninvasive dual-frequency monopolar radiofrequency; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days after the final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From first treatment through 90 days after the final treatment

Collaborators and Investigators

• Sponsor: CynosureLutronic

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LMP24001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes