Novel method for facial rejuvenation using Er:YAG laser equipped with a spatially modulated ablation module: An open prospective uncontrolled cohort study

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1. Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijcl20 Download by: [86.57.245.148] Date: 26 February 2017, At: 05:16 Journal of Cosmetic and Laser Therapy ISSN: 1476-4172 (Print) 1476-4180 (Online) Journal homepage: http://www.tandfonline.com/loi/ijcl20 Novel method for facial rejuvenation using Er:YAG laser equipped with a spatially modulated ablation module: An open prospective uncontrolled cohort study N. V. Volkova, L. K. Glazkova, V. V. Khomchenko & N. S. Sadick To cite this article: N. V. Volkova, L. K. Glazkova, V. V. Khomchenko & N. S. Sadick (2017) Novel method for facial rejuvenation using Er:YAG laser equipped with a spatially modulated ablation module: An open prospective uncontrolled cohort study, Journal of Cosmetic and Laser Therapy, 19:1, 25-29, DOI: 10.1080/14764172.2016.1247964 To link to this article: http://dx.doi.org/10.1080/14764172.2016.1247964 Published online: 05 Dec 2016. Submit your article to this journal Article views: 21 View related articles View Crossmark data

5. 28 N. V. VOLKOVA ET AL. highly satisfied with the safety and clinical efficacy of the treat - ment. Recovery period was short and results were noticeable as early as a week post treatment. In conclusion, the RecoSMA technique is demonstrated to have positive results in panfacial skin rejuvenation without downtime or adverse effects. Since the RecoSMA methodol - ogy is not ablative and based on acoustic-interference method of skin rejuvenation using Er:YAG (2936 nm) laser, there is no risk of scars and hyperpigmentation. Further clinical studies are required to evaluate the efficacy of RecoSMA treatment for other indications such as scars and for non-facial sites, but the results shown in this study indicate RecoSMA is a promising new treatment for both clinicians and patients seeking non- invasive solutions to their aesthetic concerns. wrinkle depth was shown to be between 36 and 62%. Facial areas that showed a significant response a month after laser treatment were the forehead, periorbital and perioral areas compared to the glabellar and nasolabial fold areas. At the six-month follow-up all areas of the face showed significant improvement in skin tone, texture and appearance of wrinkles. The variability in treatment response of the different facial areas are likely due to the distinct anatomical features: in the nasola - bial and glabellar area there is greater muscle mass, and buccal fat pads that are impacted to a greater degree by gravity. Results derived from investigator scoring of clinical photography were confirmed by ultrasound measurements that demonstrated sig - nificant increase of thickness and density in the dermal and SMAS tissue layers. In terms of experience, all subjects were Figure 5. a 57-year-old female received r eco sma facial treatment with the 2936-nm e r: ya G laser system equipped with sma module. ( a ) Baseline (B) one month (C) six months after treatment. Figure 6. a 62-year-old female received r eco sma facial treatment with the 2936-nm e r: ya G laser system equipped with sma module. ( a ) Baseline (B) one month (C) six months after treatment.

4. J O u RNAL OF C OSMETIC AND L ASER Th ERAPY 27 improvement in skin tone and texture, and decrease of wrin - kles in the forehead, glabellar, periorbital and nasolabial fold areas was noted one month after the treatment; skin lifting also occurred during six months (Figure 5). In a 62-year-old female there was significant reduction in wrinkles and a lifting effect one month and six months after the treatment (Figure 6). Evaluation of side effects Overall RecoSMA treatments were very well tolerated. All patients experienced temporary mild-to-moderate erythema post treatment and recovery period lasted from 3 to 7 days. No complications occurred as those often seen with laser treatments such as crusting, infection, blistering, long-standing erythema, hyperpigmentation, or scarring. Discussion This open-label uncontrolled study was conducted to evaluate the safety and efficacy of RecoSMA treatment using an Er:YAG laser coupled with a SMA module. All 100 patients who were treated demonstrated an 18% decrease in wrinkle depth as early as a week after treatment. Improvements in skin tone and texture continued 6 months after treatment and decrease in treatment (Figure 2). Similar decreases in wrinkle depth were noted in the periorbital area (27% a week after treatment, 38% a month after treatment and 54% six months after treatment), and in the nasolabial folds (18% a week after, 24% a month after and 36% six months post treatment) (Figure 2). Rapid skin response was noted in the perioral area where there was a wrinkle decrease of 44% a week, 57% a month and 62% six months after treat - ment (Figure 2). Statistical analysis revealed that the relative decrease of wrinkle depth a month after RecoSMA treatment was significant in the periorbital and perioral, but not the gla - bellar and nasolabial fold areas. However the relative decrease of wrinkle depth in all areas of the face remained significant compared to baseline six months after treatment ( Table 2 ). At the 30-day follow-up ultrasound skin examination revealed an increase of dermal thickness and density (25% and 39% respec - tively), and increase of SMAS thickness and density (29% and 79% respectively) compared to baseline (Figure 3). Patient satisfaction was also high both in terms of the clinical results and the treatment experience. Some of the notable cases included a 41-year-old female receiving one RecoSMA facial treatment. After one month after treatment there was panfacial improvement in tone, texture and the depth of wrinkles and nasolabial folds were clearly decreased; skin lifting occurred during six months after the treatment (Figure 4). In a 57-year- old female receiving RecoSMA laser treatment, there was Figure 3. t he results of the ultrasound skin examination before ( a ) and on 30th days (B) after the laser therapy: increase of dermis thickness and density; increase of smas thickness and density. Figure 4. a 41-year-old female received r eco sma facial treatment with the 2936-nm e r: ya G laser system equipped with sma module. ( a ) Baseline (B) one month (C) six months after treatment.

6. J O u RNAL OF C OSMETIC AND L ASER Th ERAPY 29 7. Kim IK, Cho HW, Cho HY, Seo JH, Lee DH, Park SH. Facelift incision and superficial musculoaponeurotic system advancement in parotidectomy: case reports. Maxillofac Plast Reconstr Surg. 2015;37(1):40. 8. Khan HA, Bagheri S. Management of the superficial musculo- aponeurotic system (SMAS). Atlas Oral Maxillofac Surg Clin North Am. 2014;22(1):17–23. 9. Trelles MA, Khomchenko V, Alcolea JM, Martínez-Carpio PA. A novel method of facial rejuvenation using a 2940-nm erbium:YAG laser with spatially modulated ablation: a pilot study. Lasers Med Sci. 2016;31(7):1465–1471. 10. Hernandez E, Khomchenko, V., Sola A., Pikirenia II, Alcolea JM, Trelles MA. Tratamiento de las úlceras crónicas de las piernas con láser de Er: YAG y tecnología RecoSMA Treatment of chronic lower extermity ulcers with Er:YAG laser and RecoSMA Technology. Cir. Plast. Iberolatinoam. 2015:41(3):117–127. 11. Khomchenko V, G.G., Suhodolov A. The method of biological tis - sues regeneration and the device of the method realization (variants), in http://www.eapo.org/ru/patents/reestr/patent.php?id  21139 , T.r.o.E. Patient, Editor 2012: Belarus. 12. Pikirenia II, Zemlyanik AN, Khomchenko VV. Possibilities of liver regeneration with induced cirrhosis at exposure of Spatially Modulated Erbium Laser Radiation in experimental animals. Surgery News. 2015;23(2):131–137. Declaration of interest The authors report no conflicts of interest. The authors alone are respon - sible for the content and writing of the paper. References 1. Sadick NS, Dorizas AS, Krueger N, Nassar AH. The facial adipose system: Its role in facial aging and approaches to volume restoration. Dermatol Surg. 2015;41 Suppl 1:S333–S339. 2. Broughton M, Fyfe GM. The superficial musculoapouneurotic system of the face: A model explored. Anat Res Int. 2013;2013:794682. 3. Frâncu LL, Hînganu D, Hînganu MV. Anatomical evidence regard - ing the existence of sustentaculum facies. Rom J Morphol Embryol. 2013;54(3):757–761. 4. Coppini L, Zigiotti GL, Messerotti G, Nicoli Aldini R. The super - ficial musculo-aponeurotic system (SMAS) of the face and neck. Anatomy and surgical dissection. Acta Otorhinolaryngol Ital. 1983;3(4):427–437. 5. Khan HA, Bagheri S. Surgical anatomy of the superficial musculo- aponeurotic system (SMAS). Atlas Oral Maxillofac Surg Clin North Am. 2014;22(1):9–15. 6. Botti C, Botti G. Facelift 2015. Facial Plast Surg. 2015;31(5):491–503.

2. Journal of Cosmeti C and l aser t herapy 2017, V ol . 19, no . 1, 25–29 http://dx.doi.org/10.1080/14764172.2016.1247964 CASE REPORT CONTACT n eil s adick nssderm@sadickdermatology.com d ermatology, Weill Cornell m edical College, p resident of s adick d ermatology, 911 p ark a venue, n ew y ork, ny 10075, usa . Color versions of one or more of the figures in the article can be found online at http://www.tandfonline.com/ijcl . © 7 t aylor & f rancis Group, ll C Novel method for facial rejuvenation using Er:YAG laser equipped with a spatially modulated ablation module: An open prospective uncontrolled cohort stud y N. V. Volkova a , L. K. Glazkova b , V. V. Khomchenko c , and N. S. Sadick d a d ermatologist, a esthetic l aser Clinician, a esthetic m edicine d epartment, u ral s tate m edical u niversity, e katerinburg, r ussia; b d ermatologist, d epartment of s kin d iseases, a esthetic m edicine d epartment, u ral s tate m edical u niversity, e katerinburg, r ussia; c h ead of r esearch and d evelopment, d irector of linline m edical s ystems, d eveloper of the r eco sma technology, m insk, r epublic of Belarus; d d ermatology, Weill Cornell m edical College, p resident of s adick d ermatology, n ew y ork, n ew y ork, usa Introduction The current concept of age-related changes on the face and neck is based on the alteration of the skin and deeper tissues such as the adipose, skeletal and superficial musculoaponeu - rotic system (SMAS) ( 1 – 3 ). The superficial musculoaponeu - rotic system (SMAS), a thin layer of connective tissue that connects the facial muscles to the superficial and deeper facial tissue, undergoes dramatic age-related changes: elastic fibers grow thick and disorganized, collagen degenerates and sar - copenia weakens and tightens the muscles, resulting in droop - ing features and wrinkles, respectively ( 2 , 4 – 5 ). Until recently, cosmetic surgery such as rhytidectomy (SMAS facelift) was the main option to change the individual’s appearance to a more youthful one ( 6 – 8 ). Given however the current rise in demand for non-invasive face rejuvenation procedures, surgical alterna - tives have been developed. As such, a novel alternative to the SMAS facelift is the RecoSMA method using an Er:YAG laser (2936 nm) equipped with a special module Spatially Modulated Ablation (SMA). RecoSMA patented technology is non-thermal, based on the microablation of the upper layer of the epidermis and sub - sequent formation of explosive acoustic waves ( 9 ). According to the manufacturer of the laser equipment, the SMA module permits the redistribution of the laser beam into thousands of microbeams (about 10,000/cm 2 ) of 50 m m in diameter, spaced by 50 m m. The energy fluence is 10 J/cm 2 and the power density is 40 KW/cm 2 (per microspot), which allows for the generation of very powerful acoustic waves that penetrate up to 6 mm in depth. Energy from the interfering acoustic waves leads to the mechanical destruction of cells at the dermal and SMAS tissue level and the creation of microzones of collapsed cells among intact cells, stimulating elastin and collagen remodeling. Unique to the RecoSMA technology is the mechanical damage from the dermis to SMAS level without overheating the tissue or expos - ing cells to oxygen, thus preventing fibrosis/scarring and other adverse effects while maximizing and stimulating the regenera - tive capacity of the tissue (Figure 1). The given mechanism of action has been previously assessed via histological examina - tion during the study for facial rejuvenation ( 9 ), treatment of chronic lower extremity ulcers ( 1 0 ), while the depth of the laser impact has been demonstrated in the study of liver cirrhosis treatment ( 1 1 , 1 2 ). The effect of the RecoSMA procedure is cumulative and skin rejuvenation continues for 3–4 months post-treatment due to collagen maturation ( 1 0 , 1 2 ). In this open-label uncon - trolled prospective cohort study, the efficacy of RecoSMA for face rejuvenation was evaluated in 100 female patients. Results demonstrate treatments are safe with high patient satisfaction and positive outcomes in reversing the signs of facial aging. ABSTRACT Facial aging is a complex biological process that affects the skin and superficial musculoaponeurotic system (SMAS). A new technology (RecoSMA) for skin rejuvenation based on acoustic-interference method using Er:YAG laser (2936 nm) equipped with a special module SMA that targets both the dermis and SMAS was evaluated in an open-label prospective cohort study of 100 female patients treated for facial rejuvenation. Measure of clinical improvement included investigator-rated clinical photography using the Modified Fitzpatrick Wrinkle Scale, and ultrasound measurements in the dermis a week, 30 days and six months post treatment. All patients completed the study and no complications were noted. Improvements in skin tone and texture were noted in all participants and significant decrease in wrinkle depth was demonstrated at the six-month follow-up that was confirmed by ultrasound skin measurements. Data presented herein confirm the safety and efficacy of RecoSMA treatment for facial rejuvenation. ARTICLE HISTORY r eceived 24 m arch 2016 a ccepted 9 o ctober 2016 KEYWORDS e r: ya G laser; facial rejuvenation; r eco sma ; sma module

3. 26 N. V. VOLKOVA ET AL. Evaluation of clinical efficacy During the screening visit, patient skin types were documented according to the Fitzpatrick Skin Type and by ultrasound skin examination. Wrinkle depth was evaluated using the Modified Fitzpatrick Wrinkle Scale (MFWS), a validated 7-point rating scale ranging from 0 (no wrinkle) to 3 (deep wrinkle) in differ - ent areas of the face (forehead, glabellar, periorbital area, naso - labial fold, perioral area) ( Table 1 ). Clinical efficacy was assessed a week, a month, and six months post treatment by an investi - gator using the MFWS and ultrasound evaluation. Ultrasound skin examination was carried out on the SkinScanner DUB CUTIS 22 MHz. Clinical photography was done at baseline and at follow-up appointments. All patients were photographed from five sides: full face, right and left side views, right and left three quarter view. Statistical analysis Data were recorded on an IBM SPSS Statistics 22.0 system. Mean  standard deviation, percentage values were calculated. Calculated p values smaller than 0.05 were accepted as being significant. Results All 100 patients successfully completed the study and experi - enced improvement of skin structure, decrease of wrinkle depth and lifting of soft tissues immediately after RecoSMA treatment. In the forehead area, decrease in wrinkle depth was 25% after a week, 41% after a month and 53% after six months post treat - ment (Figure 2). In the glabellar area, wrinkle depth decreased 25% after one week, 35% after a month and 48% six months post Materials and methods Patients This study was an open prospective cohort study. A total of 100 female patients 29 to 70 years old were enrolled in the study. All patients provided written, informed consent. Exclu - sion criteria included: pregnancy, breastfeeding, internal chronic disease, infectious disease, active skin disease (infec - tion, psoriasis, eczema, various dermatitis, etc.), autoimmune disease, and skin cancer. Subjects were also excluded if they received any other investigational treatment or had partici - pated in another clinical study within 60 days prior to study enrollment. Laser treatment All patients received one laser treatment session with the Er:YAG Laser and SMA module (LINLINE Medical Sys - tems). Before treatment, patient’s skin was cleaned and dried. Treatment parameters were 2.12–2.21 J/cm 2 and 3 Hz and target areas spanned from the hairline to the chin. Perior - bital areas including eyelids were treated with “RecoSMA-of surface action” and the other facial areas were treated with “RecoSMA-of deep action.” Laser beams were applied using scan patterns such as “olympic rings.” All patients took sys - temic acyclovir 1000 mg/day the day of treatment and two days after laser therapy, as an anti-viral preventative measure. Patients applied 5% dexpanthenol cream 2–3 times per day and 0.05% chlorhexidine the digluconate solution forty-eight hours after treatment. Figure 2. t he relative decrease of wrinkle depth on 7th-10th, 30th, 180th days after the laser therapy in different facial areas. Figure 1 . t he histologic study of the skin under the influence of the e r: ya G laser (2936 nm) equipped with a special module sma : mechanical destruction of cell membranes, nucleus and cytoplasm in the dermis. Table 1 . t he wrinkle depth (mm) in different areas of the face according to mf W s . Wrinkle depth (mm) ( mf W s ) a rea r ange (mm) a verage value f orehead 0.5–2.5 1.77  0.49 Glabellar 0.5–3 1.86  0.54 p eriorbital 1–3 2.06  0.41 n asolabial fold 1–3 2.42  0.52 p erioral 0–2.5 1.05  0.67 Table 2 . t he comparison of the percentage (%) of decrease in wrinkle depth in different areas of the face between 1 week, 1 month and 6 months after the laser therapy. a rea 1 week 1 month 6 months P f orehead 25.02  21.71 40.86  26.14 53.46  25.54  0.05 Glabellar 24.53  23.40 34.91  26.34 47.86  20.53  0.05 p eriorbital 27.22  17.39 38.18  19.41 54.05  13.87  0.05 n asolabial fold 18.01  14.70 24.26  18.45 35.59  20.65  0.05 p erioral 44.33  36.92 57.20  37.18 62.38  31.91  0.05

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