< Clinical data

Novel technology for facial treatment at home (Levenberg 2021)


Skin resurfacing made easy rf-first fractional

EDGE by ENVIG. Home use device for facial treatment

Alex Levenberg, M.D. Physician’s Center, Plastic Surgery Dept., Tel Aviv, Israel / November 2021


Objective: Evaluating the safety and efficacy of the EDGE device for facial rejuvenation treatment.


Methods: Six female subjects underwent facial treatments twice a week for six–eight weeks using the EDGE device. The device includes three treatment levels designed explicitly for facial treatments. Results were objectively recorded and analyzed with a skin-analyzing imaging system.


Results: Following the EDGE facial treatments, an improvement in facial texture and facial wrinkles was achieved and analyzed by the Visia imaging system.


Conclusions: Findings demonstrated the safety and efficacy of the EDGE treatment protocol for facial skin rejuvenation and texture improvement. Treatments resulted in smoother skin with a more even texture and wrinkles reduction.


Introduction


Over time, skin layers show wear and tear caused by aging, injury, and environmental factors.


The result is wrinkles, age spots, uneven texture, and discoloration.


RF energy has long been known to encourage collagen and ECM (Extra Cellular Matrix) production in the dermis.


Radiofrequency and resurfacing treatments restore a youthful, flexible, tight, and beautiful complexion by removing damaged outer layers of skin and promoting collagen growth.


Non-invasive fractional RF resurfacing treatments remove dead skin cells and improve skin complexion.


The effect is both immediate and long-term.


New Technology for Home Use


The EDGE’s, Non-Invasive Fractional RF delivers two unique energy pulses; the first is a superficial Matrix directed to the skin’s epidermis layer, for optimal resurfacing and smoothening effects. The second pulse, is Volumetric, driving deeper into the skin’s layers for skin tightening and accelerating the renewal rate of collagen and ECM.


Combined, the dual pulses improve skin’s health and appearance and produce a youthful and radiant glow skin.


ENVIG EDGE – Mechanism, Target, and Potential Clinical Benefits


 


ENVIG Edge is the latest breakthrough in anti-aging technology that resurfaces, renews, and rejuvenates the skin using the sheer power of Fractional RF Energy.


ENVIG EDGE delivers fractional RF energy via high-energy microbeams (Energy 49 Microbeams) in a targeted grid pattern via patented dual-energy pulse technology.


The ENVIG EDGE device allows a focused RF energy emission through a flat electrode. Each pulse is comprised of two sub-pulses:




  1. 1st energy pulse – designed to disrupt the outer layer of the epidermis for optimal and painless resurfacing.

  2. 2nd energy pulse – Designed for non-invasive volumetric heating of the dermis, stimulating the production of new collagen, elastin, and hyaluronic acid to tighten the skin and reduce the appearance of fine lines and wrinkles.


 

Figure 1

Figure 1: The distal end of the EDGE device

Figure 2
Figure 2: EDGE Energy is delivered via a matrix of electrodes



Objectives


To evaluate the safety and efficacy of a new home use device (“EDGE”) on healthy adult female facial skin based on skin analysis measurements clinical evaluation and


self-questionnaire.


Methodology


Six healthy female subjects, aged 38- 62, received facial treatment twice a week for six-eight weeks with the EDGE device (range of 14-20 treatments. The number varied according to individual specific needs)


Facial treatments were performed using a combination of the EDGE low, medium, and high levels. The device head was mainly used on the cheeks and forehead.


The average treatment time was 4-7 minutes, depending on the patient’s pace of treatment.


Results were evaluated using photographs taken with objective evaluations of Visia skin analysis.


Visia skin analysis measures skin texture, wrinkles, pores, and spots and compares before and after treatment results.


Clinical Results:


EDGE treatment results in significant improvements in skin texture, wrinkles reduction, pores reduction, and spot quantity reduction as seen in the sample photographs below (Figures 3-15).




Figure3

Figure 3: Example of spots quantity reduction before EDGE treatment and after 8 weeks


Figure 4

Figure 4: Example of skin texture improvement before EDGE treatment and after 8 weeks. Skin is smoother and more even.


Figure 5

Figure 5: Example of pores reduction before EDGE treatment and after 8 weeks. Skin is smoother and more even.


Figure 6
Figure 6: Example of

spots quantity reduction before EDGE treatment and after 8 weeks- Right Cheek

Figure 7


Figure 7: Example of spots quantity reduction before EDGE treatment and after 8 weeks- Left Cheek


Figure 8

Figure 8: Example of forehead skin texture improvement before EDGE treatment and after 8 weeks. Skin is smoother and more even.


Figure 9

Figure 9: Example of spots quantity reduction before EDGE treatment and after 8 weeks


Figure 10

Figure 10: Example of wrinkles reduction before EDGE treatment and after 8 weeks


Figure 11

Figure 11: Example of wrinkles reduction before EDGE treatment and after 7 weeks


Figure 12

Figure 12: Example of spots quantity reduction before EDGE treatment and after 11 weeks


Figure 13

Figure 13: Example of mild spots quantity reduction before EDGE treatment and after 10 weeks




Figure 14

Figure 14: Example of skin smoothness improvement before EDGE treatment and after 8 weeks


Figure 15

Figure 15: Example of skin smoothness improvement before EDGE treatment and after 8 weeks


 

 

There were no significant adverse effects detected during the study period.


On a scale of 1 to 5, subjects rated their sensation during facial EDGE treatment (1 signifies extremely uncomfortable and 5 signifies extremely comfortable).


83.3% of patients rated their sensation as comfortable or highly comfortable


The average comfort score was 4.2 out of 5.


 


Summary:


EDGE is a safe and effective method of improving facial smoothness, skin texture, and wrinkle reduction based on Fractional RF technology. It is reported that most patients experienced long-term results after using the EDGE facial home-use device. Different intensity levels provide added value for a pleasant facial treatment.


References:




  1. Skin Resurfacing Guide. https://www.americanboardcosmeticsurgery.org/procedure-learning-center/non-surgical/skin-resurfacing-guide/

  2. Otley, C. C. (2000). Resurfacing of the face: choices of therapy. Dermatologic Therapy, 13(2), 201-205.‏


 

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