Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

Part of paid clinical trials in Naperville, Illinois.

Sponsor
CynosureLutronic
Study ID
NCT07585591
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Noninvasive dual-frequency monopolar radiofrequency — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 20, 2025
Status verified
May 2026
Primary completion
Aug 12, 2025
Completion
Aug 12, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XERF Treatment

Primary Outcome Measure

Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate [ Time Frame: 90 days after the final treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Oak DermatologyNapervilleIllinois60563-
Maryland Dermatology Laser, Skin, & Vein Institute, LLCHunt ValleyMaryland21030-
New Jersey Plastic SurgeryMontclairNew Jersey07042-
Laser & Skin Surgery Center of PennsylvaniaDevonPennsylvania19333-

Find similar trials in Naperville, IL

By research site
Oak Dermatology· Naperville, ILMaryland Dermatology Laser, Skin, & Vein Institute, LLC· Hunt Valley, MDNew Jersey Plastic Surgery· Montclair, NJLaser & Skin Surgery Center of Pennsylvania· Devon, PA

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