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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XERF Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oak Dermatology | Naperville | Illinois | 60563 | United States | ||
| Maryland Dermatology Laser, Skin, & Vein Institute, LLC |
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|
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 |
| Hunt Valley |
| Maryland |
| 21030 |
| United States |
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| Laser & Skin Surgery Center of Pennsylvania | Devon | Pennsylvania | 19333 | United States |