DISCUSSION
This was a prospective, evaluator-blinded study of the performance of FRF for the treatment and reduction of wrinkles for 10 subjects. Wrinkles, as assessed by the evaluators blinded to the treatment who reviewed the before and after treatment images, were reduced and showed improvement over the timeperiod studied. Moreover, none of the subjects experienced any adverse events, pain was rated low to moderate, and majority of subjects were satisfied or very satisfied with the treatment and outcomes achieved.
The FRF technology uses an array of electrodes that produce ablative and coagulative micro-thermal injuries to the epidermis and dermis with interspersed areas of unaffected skin. This provokes a significant dermal wound healing response, resulting in fibroblast stimulation and subsequent collagen remodeling. This is demonstrated by the increased levels of Type I and Type III procollagen and elastin found in skin biopsy samples post FRF treatment.1,9 The added collagen volume, the improvement in elasticity along with melanin/erythema index, contributes to improvement of rhytids. The FRF device used in this study is different than microneedling FRF, as the pins do not penetrate the skin. Energy is distributed through small footprint per pin at variable energy densities in a single tip, reducing the risk of post-inflammatory hyperpigmentation and leaving sufficient intact tissue in between, for faster wound healing, uniform posttreatment tissue appearance, and low downtime.
Photoaging caused by cumulative UV exposure and intrinsic aging process results in thinned skin and reduced quantity and quality of collagen in the dermis and hypodermis.20,21 Furthermore, skin starts producing an estimated 1 percent less collagen every year once a person turns 20 years old.22 The perioral area of the face is one of the foremost areas on the face that may develop rhytids. Part of this is due to the thinness of the skin, which already has less collagen compared to other areas of the face. Although lifting procedures, such as face-lift and thread lift, are effective for treatment of skin laxity, they cannot improve skin texture or achieve skin rejuvenation. Fractional radiofrequency treatments have been proved to stimulate collagen and elastin production while safely and effectively promoting long-lasting skin rejuvenation results that treat laxity.23 Additionally, an advantage of FRF treatment is the small treatment tip, which makes this area accessible, and the high variable fluence for safe specific targeting of skin depth. The FWES was used in this study to measure wrinkle reduction. Results showed key areas of the face, the upper lip and perioral area, were statistically significantly improved (P<0.05) after treatment with FRF. When stratifying areas of the face, the perioral area and upper lip area were the most improved areas of focus (P<0.05), furthering the evidence that FRF is a strong choice in skin rejuvenation in the lower two-thirds of the face. Interestingly, subjects reported seeing a substantial difference in their peri-orbital area post treatment (44.4% reported a change post treatment), whereas expert graders did not notice as significant a change in photographs. That may be explained by that crow's feet are an example of a dynamic wrinkle which tend to show when the muscles are in use (for example when someone smiles). The treatment may have had a more measurable effect on the dynamic crow's feet that the patient noticed, but it was not visible in 2D static photographs to the graders. The GAIS also showed significant improvement in skin texture and appearance (P<0.05) 12-weeks post last treatment. Satisfaction was consistent over the two follow-up visits; the satisfaction scores at the 6-week follow-up did not differ significantly from the 12-week follow-up (P>0.05). Subjects reported the most common specific textural skin change was smoother skin (58% reported a noticeable change) and most subjects (80%) would recommend this treatment to a friend. The reported pain was rated as moderate (3.93 out of 10) and not as low pain. This treatment did not use any kind of anaesthetic or pain treatment. This value would potentially be much lower with numbing agents involved. In subjects who tend to feel more pain, pre-treatment anesthesia is recommended.
A further advantage of FRF is that FRF does not show evidence of hyaluronic acid filler disruption, a common concern amongst potential patients.24 Additionally, FRF does not target specific chromophores in the skin and therefore is safe in darker skin types because the risks of pigmentary changes post-treatment are minimal, while helping to maintain healthy skin texture.25 Fractional radiofrequency has been shown to improve skin texture.26 Additionally, FRF has been shown to improve skin roughness in over 70% of patients,27 which was similar to the results shown in this study, where 58% reported a noticeable change in skin smoothness.
Limitations of the study included the relatively small sample size that limited the power of the study. Additionally, a shorter time follow-up period of FWES could have shown results much faster than at 6 or 12 weeks, while a longer follow-up period could have allowed for the assessment of the longevity of all the outcomes (for example 6 or 12 months after treatment). More treatments may result in greater improvements in some patients' rhytids. Finally, inclusion of a wider range of skin types would have been beneficial to show the safety and efficacy of FRF for facial rhytids in darker skin types.
The FRF technology uses an array of electrodes that produce ablative and coagulative micro-thermal injuries to the epidermis and dermis with interspersed areas of unaffected skin. This provokes a significant dermal wound healing response, resulting in fibroblast stimulation and subsequent collagen remodeling. This is demonstrated by the increased levels of Type I and Type III procollagen and elastin found in skin biopsy samples post FRF treatment.1,9 The added collagen volume, the improvement in elasticity along with melanin/erythema index, contributes to improvement of rhytids. The FRF device used in this study is different than microneedling FRF, as the pins do not penetrate the skin. Energy is distributed through small footprint per pin at variable energy densities in a single tip, reducing the risk of post-inflammatory hyperpigmentation and leaving sufficient intact tissue in between, for faster wound healing, uniform posttreatment tissue appearance, and low downtime.
Photoaging caused by cumulative UV exposure and intrinsic aging process results in thinned skin and reduced quantity and quality of collagen in the dermis and hypodermis.20,21 Furthermore, skin starts producing an estimated 1 percent less collagen every year once a person turns 20 years old.22 The perioral area of the face is one of the foremost areas on the face that may develop rhytids. Part of this is due to the thinness of the skin, which already has less collagen compared to other areas of the face. Although lifting procedures, such as face-lift and thread lift, are effective for treatment of skin laxity, they cannot improve skin texture or achieve skin rejuvenation. Fractional radiofrequency treatments have been proved to stimulate collagen and elastin production while safely and effectively promoting long-lasting skin rejuvenation results that treat laxity.23 Additionally, an advantage of FRF treatment is the small treatment tip, which makes this area accessible, and the high variable fluence for safe specific targeting of skin depth. The FWES was used in this study to measure wrinkle reduction. Results showed key areas of the face, the upper lip and perioral area, were statistically significantly improved (P<0.05) after treatment with FRF. When stratifying areas of the face, the perioral area and upper lip area were the most improved areas of focus (P<0.05), furthering the evidence that FRF is a strong choice in skin rejuvenation in the lower two-thirds of the face. Interestingly, subjects reported seeing a substantial difference in their peri-orbital area post treatment (44.4% reported a change post treatment), whereas expert graders did not notice as significant a change in photographs. That may be explained by that crow's feet are an example of a dynamic wrinkle which tend to show when the muscles are in use (for example when someone smiles). The treatment may have had a more measurable effect on the dynamic crow's feet that the patient noticed, but it was not visible in 2D static photographs to the graders. The GAIS also showed significant improvement in skin texture and appearance (P<0.05) 12-weeks post last treatment. Satisfaction was consistent over the two follow-up visits; the satisfaction scores at the 6-week follow-up did not differ significantly from the 12-week follow-up (P>0.05). Subjects reported the most common specific textural skin change was smoother skin (58% reported a noticeable change) and most subjects (80%) would recommend this treatment to a friend. The reported pain was rated as moderate (3.93 out of 10) and not as low pain. This treatment did not use any kind of anaesthetic or pain treatment. This value would potentially be much lower with numbing agents involved. In subjects who tend to feel more pain, pre-treatment anesthesia is recommended.
A further advantage of FRF is that FRF does not show evidence of hyaluronic acid filler disruption, a common concern amongst potential patients.24 Additionally, FRF does not target specific chromophores in the skin and therefore is safe in darker skin types because the risks of pigmentary changes post-treatment are minimal, while helping to maintain healthy skin texture.25 Fractional radiofrequency has been shown to improve skin texture.26 Additionally, FRF has been shown to improve skin roughness in over 70% of patients,27 which was similar to the results shown in this study, where 58% reported a noticeable change in skin smoothness.
Limitations of the study included the relatively small sample size that limited the power of the study. Additionally, a shorter time follow-up period of FWES could have shown results much faster than at 6 or 12 weeks, while a longer follow-up period could have allowed for the assessment of the longevity of all the outcomes (for example 6 or 12 months after treatment). More treatments may result in greater improvements in some patients' rhytids. Finally, inclusion of a wider range of skin types would have been beneficial to show the safety and efficacy of FRF for facial rhytids in darker skin types.
CONCLUSION
In conclusion, our results suggest that FRF is effective in the
treatment of wrinkles, without significant adverse events.
Moreover, FRF treatments showed improvements in overall
skin quality and pigmentation. The FRF device may be a viable
alternative for fractional laser devices for the treatment of rhytids
for subjects looking for shorter recovery times and looking to
avoid the drawbacks of fractional laser treatments.
