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Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

NCT07585591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Facial Aging
  • Facial Skin Laxity
  • Submental and Neck Skin Laxity

Interventions

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.

Sponsors & Collaborators

  • CynosureLutronic

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-08-12
Completion
2025-08-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585591 on ClinicalTrials.gov