Facial AgingNCT07585591
Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments
A study testing Noninvasive dual-frequency monopolar radiofrequency in people with Facial Aging and Facial Skin Laxity, run by CynosureLutronic at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Aging, Facial Skin Laxity, Submental and Neck Skin Laxity
- What is being tested?
- Noninvasive dual-frequency monopolar radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jan 2025to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Laser & Skin Surgery Center of Pennsylvania
Devon, Pennsylvania, 19333
Maryland Dermatology Laser, Skin, & Vein Institute, LLC
Hunt Valley, Maryland, 21030
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Oak Dermatology
Naperville, Illinois, 60563
About this study
Official title: 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.
- Being tested
- Noninvasive dual-frequency monopolar radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| XERF Treatment | Experimental | Not described Receives: Device: Noninvasive dual-frequency monopolar radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after the final treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From first treatment through 90 days after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start20 Jan 2025
- Primary completion12 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585591
- Sponsor's protocol ID
- LMP24001
- Status last verified
- May 2026
- First submitted
- 5 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the XERF Device for Aesthetic Treatments
- ClinicalTrials.gov ID
- NCT07585591
- Acronym / sponsor ID
- LMP24001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XERF Treatment | Experimental | Device: Noninvasive dual-frequency monopolar radiofrequency |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive dual-frequency monopolar radiofrequencyParticipants 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. | Device | XERF Treatment |
Primary outcome
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate
Time frame: 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.
3 secondary outcomes
Patient Satisfaction Score (PSS) Responder Rate
Time frame: 30 and 90 days after the final treatment
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate at 30 Days
Time frame: 30 days after the final treatment
Incidence of Adverse Events
Time frame: From first treatment through 90 days after the final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive dual-frequency monopolar radiofrequency in people with Facial Aging and Facial Skin Laxity, run by CynosureLutronic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate (time frame: 90 days after the final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.