Ahmad Nasrollahi, S.

Firooz, A.

Janani, L.

Kamyab Hesari, K.

Moosavi, Z.B.

Rezaie Kalantari, A.

Samadi, A.

eprints Iran University of Medical Sciences

Letter to the Editor© 2019 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.comDOI: 10.1093/asj/sjy320www.aestheticsurgeryjournal.comAesthetic Surgery Journal2019, Vol 39(3) NP29–NP31Dr Samadi is a PhD candidate, Dr Moosavi and Dr Ahmad Nasrollahi are Associate Professors, and Dr Firooz is a Professor, The Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences, Tehran, Iran. Dr Janani is an Assistant Professor, Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Dr Kamyab Hesari is an Associate Professor, Department of Dermatopathology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran. Dr Kalantari is the CEO of Medaria, a medical device company, Tehran, Iran.Corresponding Author: Dr Alireza Firooz, Center for Research & Training in Skin Diseases & Leprosy (CRTSDL), Tehran University of Medical Sciences (TUMS), #415 Taleqani Ave, Tehran, Iran. E-mail: firozali@tums.ac.irResponse to “A Critique of Radiofrequency Treatments for Facial Rejuvenation”Aniseh Samadi, MD, PhD ; S. Ahmad Nasrollahi, PharmD, PhD;  Leila Janani, PhD; Zahra Beigom Moosavi, MD;  Kambiz Kamyab Hesari, MD; Arash Rezaie Kalantari, MD; and  Alireza Firooz, MDEditorial Decision date: November 28, 2018; online publish-ahead-of-print January 4, 2019.We thank Dr Swanson for his comments1 on our study assessing the safety and efficacy of a combination treat-ment using fractional radiofrequency and a thermo-con-traction system for facial skin rejuvenation.2 He has noted the strengths of our study, and has also raised some ques-tions and doubts, to which we respond below.He stated that we have not used standardized photo-graphs in Figure 3 of the article. This figure presents an image taken with the VisioFace Quick system (Courage & Khazaka electronic GmbH, Cologne, Germany), and the green specks show the measurement of the right naso-labial fold using CSI software, an approach that is well established and has been used successfully in a variety of studies.3,4 Therefore the measurement of the wrinkle area was not manual, but had been performed automatically by the software on original images, and is independent of the size of the photographs presented in the paper. We had at proof stage asked the journal to publish the photographs in the same size, and hope this will be corrected in the final print version of the paper.Additionally, Dr Swanson refers to his use of the Canfield 7.4.1 mirror-imaging software and mentions that it “simply measures the distance between two landmarks for wrinkle measurement.” However, wrinkle analysis using CSI software is a 3-dimensional (3D) process and can evaluate the depth of a wrinkle, as well as the 2D surface area. The improvements in wrinkles reported in our study also included a significant decrease in wrinkle volume (P = 0.031), and this is related to reducing the wrinkle depth as well as the wrinkle surface area.Dr Swanson claims that in spite of a significant improve-ment in the echo-density of the dermis 3  months after treatment, the measurement returned to below baseline at 6 months; in fact, however, there was no significant sta-tistical difference in dermis echo-density when comparing month 6 with baseline (P = 0.157). Our study notes that the treatment was not sustainable and measurement has returned to baseline (not below baseline) after 6 months.He also argues that the standard deviations (SDs) of the Glogau wrinkle scores (0.80 and 0.79) are relatively large and the difference in means is tiny. However, we can find small but significant differences in subjective cate-goric scales. For example, Gold et al5 reported a significant improvement in the Fitzpatrick wrinkling scale when the Fitzpatrick wrinkling scale decreased from 3.45 ± 1.4 at baseline to 3.12 ± 1.3 at month 3.applyparastyle "fig//caption/p[1]" parastyle "FigCapt"applyparastyle "fig" parastyle "Figure"My WayDownloaded from https://academic.oup.com/asj/article/39/3/NP29/5273608 by Tehran University of Medical Science user on 27 October 2020Samadi et al NP30Large SDs are usually reported in results of categoric parameters, especially when using small sample sizes. Seo et al6 conducted a comparative study on 15 subjects treated with fractional radiofrequency alone, and fractional radiof-requency plus stem cell–conditioned medium. The mean degrees of improvement in their report using a 4-degree scale were 2.06 ± 0.70 and 2.20 ± 0.68, respectively. The means and SDs reported by Seo et al are comparable to the values noted in our report.Moreover, the wrinkle scores in our study had a nor-mal distribution based on the Kolmogorov-Smirnov test, and therefore parametric tests were used to analyze these scores (Table 1).A number of authors also accept that the “t test” is not the preferred method for comparing categoric scores; how-ever, using t tests is not uncommon in aesthetic categoric assessments. Seo et al6 compared “patient’s overall satis-faction score” and “blinded investigator evaluation” (both categoric) in 2 interventions using paired t tests. Moreover, Gold et  al5 compared Fitzpatrick wrinkling scale values before and after intervention through the use of paired t tests.Dr Swanson inquired about the number of patients who were dissatisfied with the treatment. Detailed data about the number of participants and their satisfaction scores are shown in Figure 1. As it is clear there was only 1 dissatisfied participant in the final treatment ses-sion, we did not report this figure in the original paper due to space limitations.We stated in the introduction to our paper that it is claimed that thermo-contraction can stimulate muscle con-traction and can have a lifting effect. As Dr Swanson notes, we did not observe any findings that support this claim because the decrease in laxity score was not significant. However, using a larger sample size might lead to different results.As we declared, Dr Kalantari, one of the authors, is a shareholder of the company that funded this study. He also is a physician with experience in aesthetic medi-cine and was involved in the study design, interpretation of data, and preparation of the manuscript, but had no role in the treatment and assessment of patients, or in the gathering and analysis of data. We therefore believe that his being a shareholder did not have any influence on the integrity of this study. Moreover, he did not receive any payment for the radiofrequency treatments, as the treat-ments and assessments were provided free of charge to the participants.Dr Swanson claims that corporate-funded studies can be subject to financial conflicts. We are well aware of this limitation, and we therefore maximized our objectivity and limited any bias by performing neutral and blinded assessments of patients, by adhering to the principles of Good Clinical Practice, and by registering the study on an open clinical trial registry website.As Dr Swanson mentions, nonsurgical thermal skin treatments might cause some burning discomfort, but the adverse effects are not comparable with surgery because they are mild in severity and duration.In conclusion, we also believe that surgery remains the gold standard of treatment for advanced facial aging, but nobody can deny the increasing demand for minimally invasive procedures to improve the signs of aging, as shown by data provided by the American Society of Plastic Surgeons.7 Many patients are poor candidates for surgery or reluctant for various reasons to undergo surgery. Recent advances in energy-based devices have seen the intro-duction of several skin-rejuvenation systems—radiofre-quency, lasers, high-intensity focused ultrasound, etc.—to improve skin aging. Several studies, both corporate funded and independent, have confirmed the efficacy of these treatments, many of which have now been approved by Table 1. Results of Nonparametric Test (Kolmogorov-Smirnov) for Wrinkle Scores at Baseline and 3 and 6 Months After Last Treatment Wrinkle score Baseline Month 3  Month 6Mean 2 1.86 1.75Kolmogorov-Smirnov z 0.62 0.76 0.85P value 0.83 0.60 0.45Figure 1. Number of participants and their satisfaction scores at the last treatment session, and 3 and 6 months later.Downloaded from https://academic.oup.com/asj/article/39/3/NP29/5273608 by Tehran University of Medical Science user on 27 October 2020NP31 Aesthetic Surgery Journal 39(3)regulatory agencies worldwide. Therefore, in contrast to Dr Swanson, we believe there is a place for the use of these devices in selected patients. Although none of these meth-ods are comparable to surgery in terms of efficacy and lon-gevity, these treatments could nevetheless be beneficial, especially in the early stages of aging, as they offer fewer side effects, less down time, and lower costs.DisclosuresDr Kalantari is the CEO of and a shareholder in Medaria Company (Tehran, Iran). The other authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.FundingThe authors received no financial support for the research, authorship, and publication of this article.REFERENCES 1. Swanson E. A critique of radiofrequency treatments for facial rejuvenation. Aesthet Surg J. 2019;39(3):NP26–NP28. 2. Samadi A, Nasrollahi SA, Janani L, et al. Combination of fractional radiofrequency and thermo-contraction systems for facial skin rejuvenation: a clinical and histological study. Aesthet Surg J. 2018;38(12):1341-1350. 3. Berardesca  E, Ardigo  M, Cameli  N, Mariano  M, Agozzino  M, Matts  PJ. Randomized, double-blinded, vehicle-controlled, split-face study to evaluate the effects of topical application of a Gold Silk Sericin/Niacinamide/Signaline complex on biophysical parameters related to skin ageing. Int J Cosmet Sci. 2015;37(6): 606-612. 4. Amirkhani MA, Shoae-Hassani A, Soleimani M, Hejazi S, Ghalichi L, Nilforoushzadeh MA. Rejuvenation of facial skin and improvement in the dermal architecture by transplantation of autologous stromal vascular fraction: a clinical study. Bioimpacts. 2016;6(3):149-154. 5. Gold  AH, Pozner  J, Weiss  R. A fractional bipolar radiofrequency device combined with a bipolar radiofrequency and infrared light treatment for improvement in facial wrinkles and overall skin tone and texture. Aesthet Surg J. 2016;36(9):1058-1067. 6. Seo  KY, Kim  DH, Lee  SE, Yoon  MS, Lee  HJ. Skin rejuvenation by microneedle fractional radiofrequency and a human stem cell conditioned medium in Asian skin: a randomized controlled investigator blinded split-face study. J Cosmet Laser Ther. 2013;15(1): 25-33. 7. American Society of Plastic Surgeons. New Statistics Reveal the Shape of Plastic Surgery. https://www.plasticsurgery.org/news/press-releases/new-statistics-reveal-the-shape-of-plastic-surgery. Accessed November 6, 2018.Downloaded from https://academic.oup.com/asj/article/39/3/NP29/5273608 by Tehran University of Medical Science user on 27 October 2020

Response to "a critique of radiofrequency treatments for facial rejuvenation"

http://eprints.iums.ac.ir/14982/1/Response-to-a-critique-of-radiofrequency-treatments-for-facial-rejuvenation2019Aesthetic-Surgery-Journal.pdf

Response to "a critique of radiofrequency treatments for facial rejuvenation"

Abstract

Similar works

Full text

Available Versions

eprints Iran University of Medical Sciences