and grades the overall aesthetic improvement of the subject. For the 21 patients who completed the study, photographs were reviewed in a blinded fashion where the pre-treatment and post-treatment photographs were not ordered. Nine (9) patients were noted to have improvement. In no case were the after photographs designated as worse than the before photographs.
DISCUSSION
Treatment sessions using FRF were well tolerated, and only 1 moderate adverse event was reported. Patients were satisfied with the results. After 3 treatment sessions at medium to high energy settings, the treatment showed subjective improvement in skin texture and wrinkles, with the improvements remaining for at least 3 months after the last session.
Patient satisfaction is increasingly recognized as a critical factor in determining the quality of care.12-17 Higher patient satisfaction has been shown to have a positive effect on patient retention, compliance, and reduce medical malpractice claims.18 Moreover, in aesthetic operations, patient satisfaction may be an outcome indicator in deciding whether patients return for subsequent procedures.19 Several other clinical studies have indicated that FRF technologies are successful in the treatment of skin laxity and wrinkles.15,20-25 Using the FRF technology described in this study, columnar quantities of tissue can be ablated with a zone of residual surrounding coagulation. This allows for highly customizable treatments, depending on the severity of wrinkles. FRF at various energy levels triggers a wound healing response with resolution within a 1-week period.26 Additionally, FRF volumizes the dermis by stimulating endogenous formation of 3 key dermal constituents: collagen, elastin, and hyaluronic acid.
Many other FRF devices include sharp needles that are mechanically inserted into the skin before FRF energy is discharged. The insertion of these needles into the skin contributes to discomfort. The method we describe here is micro "pinning," which uses FRF to ablate fractions of the epidermis and external papillary dermis, without physical needle insertion into the dermis. The pins are placed against the skin during the energy delivery (Figure 6). This reduces the level of pain and the incidence of adverse events such as bleeding and post treatment hyperpigmentation. In our analysis, there was no difference in satisfaction results or aesthetic outcomes between the 80-pin applicator and 160-pin applicator. Although the difference was not statistically significant, with more participants, a significant effect may be noted. The 80â€pin tip can deliver double the amount of energy per pin compared to the 160â€pin tip (up to 124mJ/pin for the 80â€pin tip compared to up to 62mJ/pin for the 160â€pin tip), which results in increased depth of ablation.
One sign of aging is rhytids in the perioral region. Dermal fillers can improve rhytids in that region; however, perioral rejuvenation with FRF has advantages over fillers, including a more natural appearance and longer duration.27 Patients often experience improvement 6 to 8 weeks following FRF treatment and continue to improve for up to a year.28 Most investigations on the lifespan of hyaluronic filler in the perioral area use a 3-month primary endpoint.29-31 In comparison, maintenance treatment with FRF may only be necessary every 2 to 5 years.27,32–36 Following filler injection in the lips, the filler treatment of the upper lip tends to lengthen the top lip and can exacerbate wrinkling that area. FRF on the other hand, due to its coagulative impact, may result in shrinkage of the skin and moderate shortening of the upper lip. Our study found that participants saw most improvement around their mouth (45%) and around their eyes (33%), supporting FRF as an effective option for perioral/periorbital aging (Table 2).
Patient satisfaction is increasingly recognized as a critical factor in determining the quality of care.12-17 Higher patient satisfaction has been shown to have a positive effect on patient retention, compliance, and reduce medical malpractice claims.18 Moreover, in aesthetic operations, patient satisfaction may be an outcome indicator in deciding whether patients return for subsequent procedures.19 Several other clinical studies have indicated that FRF technologies are successful in the treatment of skin laxity and wrinkles.15,20-25 Using the FRF technology described in this study, columnar quantities of tissue can be ablated with a zone of residual surrounding coagulation. This allows for highly customizable treatments, depending on the severity of wrinkles. FRF at various energy levels triggers a wound healing response with resolution within a 1-week period.26 Additionally, FRF volumizes the dermis by stimulating endogenous formation of 3 key dermal constituents: collagen, elastin, and hyaluronic acid.
Many other FRF devices include sharp needles that are mechanically inserted into the skin before FRF energy is discharged. The insertion of these needles into the skin contributes to discomfort. The method we describe here is micro "pinning," which uses FRF to ablate fractions of the epidermis and external papillary dermis, without physical needle insertion into the dermis. The pins are placed against the skin during the energy delivery (Figure 6). This reduces the level of pain and the incidence of adverse events such as bleeding and post treatment hyperpigmentation. In our analysis, there was no difference in satisfaction results or aesthetic outcomes between the 80-pin applicator and 160-pin applicator. Although the difference was not statistically significant, with more participants, a significant effect may be noted. The 80â€pin tip can deliver double the amount of energy per pin compared to the 160â€pin tip (up to 124mJ/pin for the 80â€pin tip compared to up to 62mJ/pin for the 160â€pin tip), which results in increased depth of ablation.
One sign of aging is rhytids in the perioral region. Dermal fillers can improve rhytids in that region; however, perioral rejuvenation with FRF has advantages over fillers, including a more natural appearance and longer duration.27 Patients often experience improvement 6 to 8 weeks following FRF treatment and continue to improve for up to a year.28 Most investigations on the lifespan of hyaluronic filler in the perioral area use a 3-month primary endpoint.29-31 In comparison, maintenance treatment with FRF may only be necessary every 2 to 5 years.27,32–36 Following filler injection in the lips, the filler treatment of the upper lip tends to lengthen the top lip and can exacerbate wrinkling that area. FRF on the other hand, due to its coagulative impact, may result in shrinkage of the skin and moderate shortening of the upper lip. Our study found that participants saw most improvement around their mouth (45%) and around their eyes (33%), supporting FRF as an effective option for perioral/periorbital aging (Table 2).
CONCLUSION
Our results suggest that per treated participants’ opinions, FRF is effective in improving wrinkles. Also, FRF treatments resulted in prolonged improvements in overall skin quality. The FRF device may be a viable alternative for patients desiring fast results and wanting to avoid the drawbacks of fractional laser treatments and dermal fillers.
DISCLOSURES
ER and BW have no conflict of interest.
Funding: This study was sponsored by Venus Concept Inc.
Funding: This study was sponsored by Venus Concept Inc.
ACKNOWLEDGMENT
The authors would like to thank Rachel R. Mays for assistance in
the writing of this manuscript.
REFERENCES
1. Guinot C, Malvy DJ-M, Ambroisine L, Latreille J, Mauger E, Tenenhaus M, et al. Relative Contribution of Intrinsic vs Extrinsic Factors to Skin Aging as Determined by a Validated Skin Age Score. Arch Dermatol. 2002;138(11):1454–1460. doi: 10.1001/archderm.138.11.1454.
2. Daniell HW. Smoker's wrinkles. A study in the epidemiology of "crow's feet" Ann Intern Med. 1971;75(6):873–880. doi: 10.7326/0003-4819-75-6-873.
3. Green AC, Hughes MCB, McBride P, Fourtanier A. Factors Associated with Premature Skin Aging (Photoaging) before the Age of 55: A Population-Based Study. Dermatology. 2011;222(1):74–80. doi: 10.1159/000322623.
4. Kim JE, Lee HW, Kim JK, Moon SH, Ko JY, Lee MW, et al. Objective evaluation of the clinical efficacy of fractional radiofrequency treatment for acne scars and enlarged pores in Asian skin. Dermatol Surg. 2014;40(9):988– 995. doi: 10.1097/01.DSS.0000452625.01889.c3.
2. Daniell HW. Smoker's wrinkles. A study in the epidemiology of "crow's feet" Ann Intern Med. 1971;75(6):873–880. doi: 10.7326/0003-4819-75-6-873.
3. Green AC, Hughes MCB, McBride P, Fourtanier A. Factors Associated with Premature Skin Aging (Photoaging) before the Age of 55: A Population-Based Study. Dermatology. 2011;222(1):74–80. doi: 10.1159/000322623.
4. Kim JE, Lee HW, Kim JK, Moon SH, Ko JY, Lee MW, et al. Objective evaluation of the clinical efficacy of fractional radiofrequency treatment for acne scars and enlarged pores in Asian skin. Dermatol Surg. 2014;40(9):988– 995. doi: 10.1097/01.DSS.0000452625.01889.c3.
