| Objective: To observe clinical application of the new invasive fractional RF microneedle handpiece(Intensif applicator,EndyMed Medical, Cesarea, Israel) in facial skin rejuvenation. The clinical efficacy and safety of the new fractional RF microneedle handpiece in facial skin rejuvenation are assessed based on factors including efficacy, patient satisfaction, intraoperative comfort and post-surgery adverse events.Methods: 30 patients between 28 and 61 years of age(mean age 39.73±8.12 years old) participated in the study. Among subjects of 28 female and 2 male, 26 subjects are OF Fitzpatrick skin type IV. We performed a split-face study, treating the left face with Accent Pro(Alma Lasers, LTD.,Cesarea, Israel) and the right face with Intensif applicator(Endy Med Pro,EndyMed Medical, Cesarea, Israel). The study includes 3 treatments at 1-month intervals. Intraoperative were self-evaluated by the subjects based on the level of pain. Post-surgery efficacy was assessed by both the doctors and subjects. The subjects were evaluated at week 4, 8, and 12. Standardized clinical photographs were taken before and after the treatments and they were rated using blind comparison technique. 4 weeks after completion of treatment course, the severity of photoaging was reviewed by 4 board certified plastic surgeons using the method of light aging overall score evaluation system. 8 weeks after the completion of treatment course, patients were asked to self evaluate the improvement on skin laxity. Alexiades develop wrinkles and sagging dedicated rating scale evaluate the treatment after the completion of the last 12 weeks improved the patient’s skin by 4 board certified plastic surgeons. Patients were asked to complete questionnaires on topics including satisfaction, efficacy, post-treatment discomfort, downtime, etc.Results:(1) For the Intesif applicator treatments, intraoperative comfort was 3.97 on basis of the pain. 7 subjects(23.3%) experienced none to slight pain, 23(76.7%) experienced medium discomfort and none reported severe pain. In comparison, only 16.7% of the patients complained of mild pain when treated with Accent pro as the endpoint indication of treatment is the acceptable heated sensation reported by individual patient.(2) 4 weeks after 3 treatments were completed, improvement of 63.3%, mean scale-0.69±0.63.(P<0.05) on the left face treated with Accent Pro. While the right face treated with Intensif results in 100% improvement, mean scale-2.38±0.62.(P<0.05). At week 8 after completing the treatments, clinical efficacy comparisons show that the 60% of the Intensif-treated area scores a improvement scale of 3 points while only 30.7% of the Accent pro- treated area scores the same value. Using Alexiades develop wrinkles and sagging dedicated rating scale evaluation of the last 12 weeks after treatment the patient’s skin, improve clinical efficacy results for the double cheek of patients(50.0%) > 50.0% improvement;Frontal patients(43.3%), eyes(40.0%) patients with improved 51-75%; Patients with submandibular(30.0%) improved 25-50%; The muzzle(40.0%) patients with < 40.0% improvement.(3) All 30 subjects were photographed by VISIA system. The side of face treated by Accent pro shows improvement on pigmentation, pore sizes and wrinkles between the baseline and the first, second and third treatment. The improvement on erythema was only observed between baseline and first and third treatment. Comparing between first and second treatments, the improvement on wrinkles is observed. Comparing first and third treatments, improvement on pigmentation, pore sizes and wrinkles are observed. Improvement on all aspects of pigmentation, erythema, pore sizes and wrinkles can be noted between the second and the third treatment.On the side of face treated with Intensif, improvements on pigmentation, erythema, pore sizes and wrinkles can be observed after each of the three treatments from baseline. Comparing between the first and second treatments, observations of improvement are made on the aspects of pigmentation, pore sizes and wrinkles but not erythema. Further comparing first and second treatments to the third treatment, improvements on all 4 aspects were observed respectively.We can thus conclude that both Accent pro and Intensif are effective in facial rejuvenation and improvement of skin texture. At 4 weeks after treatment completion, we analyzed the data of pigmentation, erythema pore sizes and wrinkles improvements by each device. They suggest that Intensif is superior to Accent pro.(4)Adverse events: Downtime: 80% of the subjects experienced mild erythema which resolved in less than 48 hours, 50% lasted several hours and 30% lasted 1-2 days while the remaining 20% persisted for 72 hours. For all subjects, edema subsided within 24 hours. Crusting period: 80% of the subjects had none or very little scab(<5). 20% of the subjects had a medium number of tiny scabs(5-15 counts)which disappeared in 4-5 days. 90% of the subjects were able to resume normal life within 48 hours, 65% needed 24 hours, 25% needed 48 hours and 10% needed 72 hours. Hyperpigmentation period: no subject experienced hyperpigmentation. No adverse events reported during the study.Conclusion: Invasive fractional radiofrequency system practiced under standard parameters provides a satisfying method for facial rejuvenation that features little discomfort, minimal downtime, great efficacy and safety. |
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