Publications by authors named "Suzanne Kilmer"

50 Publications

Global Expert Opinion on Cryolipolysis Treatment Recommendations and Considerations: A Modified Delphi Study.

Aesthet Surg J Open Forum 2022 1;4:ojac008. Epub 2022 Feb 1.

Background: Cryolipolysis is an increasingly popular nonsurgical fat-reduction procedure. Published treatment guidance and adverse event (AE) management protocols are limited.

Objective: A modified Delphi study aimed to establish global expert consensus on the use of CoolSculpting (Allergan Aesthetics, an AbbVie Company, Irvine, CA), a noninvasive cryolipolysis treatment system.

Methods: A literature search informed survey topics for an 11-expert Delphi panel. Panelists completed an online 39-question survey. An interim panel discussion, with open-ended questions and yes/no voting, informed a second survey containing 61 statements, for which panelists rated agreement using a 5-point Likert scale. Topics included treatment outcome and responder definitions, patient evaluation and selection, treatment protocols, patient satisfaction, and AEs.

Results: Panelists achieved consensus on 38 final guidelines and recommendations. They reached moderate to complete consensus on 4 statements on defining responders (ie, patients with a range of visible improvement) and 6 statements on patient factors contributing to treatment outcomes (eg, how well the applicator conforms to patient body region). Panelists defined minimum numbers of treatment cycles to achieve visible clinical outcomes for 12 body regions, with moderate to complete consensus on 31 statements. They achieved a strong to complete consensus on 7 statements about patient satisfaction (eg, importance of patient expectations, visible improvement, and before-and-after photographs). Panelists defined management strategies for AEs, with moderate to complete consensus on 15 statements.

Conclusions: A modified Delphi process yielded multiple guideline recommendations for cryolipolysis, providing a needed resource for the broad range of clinicians who perform this noninvasive fat-reduction procedure.

Level Of Evidence 5:
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February 2022

1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations.

Dermatol Surg 2022 Feb;48(2):195-200

Miami Dermatology & Laser Institute, Miami, Florida.

Background: The Fraxel Dual laser system (Solta Medical, Inc., Bothell, WA) contains a 1,550 and 1,927 nm wavelength single handpiece with different indications for each wavelength.

Objective: To discuss treatment setting recommendations and best practices for select on-label and investigational applications of the 1,550 and 1,927 nm dual laser system.

Materials And Methods: Eight board-certified dermatologists with 10 or more years of experience with the 1,550 and 1,927 nm laser system completed an online survey about their clinical experience with the system and then participated in a roundtable to share clinical perspectives and best practices for using the laser system.

Results: For all Fitzpatrick skin types, treatment recommendations were described for selected approved indications for the 1,550 and 1,927 nm laser system, including both lasers in combination. Treatment recommendations were also reached for investigational applications with the 1,550 nm laser and 1,927 nm laser. Best practices for using the lasers during the treatment session to achieve optimal outcomes and decrease the post-treatment recovery time were compiled.

Conclusion: The 1,550 and 1,927 nm dual laser system is effective for a wide range of aesthetic and therapeutic applications, on and off the face and across all Fitzpatrick skin types.
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February 2022

Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Wrinkles: A Prospective Study.

J Drugs Dermatol 2022 Jan;21(1):43-48

Background: Fractional radiofrequency (FRF) technology has been shown in clinical studies to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures such as rhytids. The objective of this clinical study was to evaluate the safety and performance of FRF (up to 124 mJ per pin) for the treatment of facial rhytids, emphasizing the upper lip and perioral areas.

Methods: Enrolled subjects received a series of 3 FRF treatments to the full face, 3 to 5 weeks apart. Immediately after treatment, the subjects were given a scale to assess pain and tolerability of the treatment. Subject satisfaction questionnaires were completed at follow-up visits at 6 and 12 weeks post final treatment. Before and after photographs were graded for change by three blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale (FWES) and the Global Aesthetic Improvement Scale (GAIS).

Results: Image sets of 10 enrolled subjects (average age 62.7 years) were assessed by blinded evaluators. The overall face FWES score improved from 5.97 (SE 0.20) at baseline to 5.78 (SE 0.22) at 12-week follow-up. The GAIS improved by 0.4 points and was significant compared to baseline (P = 0.0004). Subject satisfaction was high with subjects giving an average satisfaction score of 3.2 (“satisfied”) out of 4. Pain was rated “mild to moderate” with an average of 3.9 on a 11-point Wong Baker FACES Scale. Ninety percent (90%) of subjects reported either a mild, moderate, or significant improvement to their treatment area. Eighty percent (80%) of subjects reported that they would recommend the treatment to a friend. There were no reports of adverse events or unanticipated side effects during the duration of the study.

Conclusion: A statistically significant reduction in rhytids of the upper lip and the perioral area, was found, as evaluated by independent blinded evaluators. There were no adverse events. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results at last follow-up. J Drugs Dermatol. 2022;21(1):43-48. doi:10.36849/JDD.6492.
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January 2022

Optimizing Outcomes With the 1550/1927 nm Dual Wavelength Non-Ablative Fractional Laser: Experienced User Recommendations.

J Drugs Dermatol 2021 Nov;20(11):1150-1157

Background: Fractional laser treatment was introduced in 2004 as a non-invasive technique to treat sun-damaged and aging skin. Since then, numerous ablative and non-ablative photothermolysis technologies and devices have been introduced, increasing the options for clinicians and patients but also increasing the complexity regarding which system to use and the techniques to optimize outcomes. No two devices are the same and the user-manuals preset dosimetry does not address many clinical situations, which can create confusion for new and inexperienced users.

Methods: An online survey addressing use of a 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser was sent to eight (8) US board certified dermatologists with extensive experience in the use of the device. The survey included 39 questions, addressing experience, best practices and recommendations for use.

Results: The survey data suggests that the device can be used to treat patients of all ages and skin types for indications including photoaging and photodamage, periorbital wrinkles, freckles, (ephelides), solar lentigines, poikiloderma, scarring due to acne or surgery. It can be used on both facial and non-facial areas, including neck, chest, hands, arms, abdomen, legs, and buttocks. Unexpected and adverse effects were rarely reported and those that did were mild and transient.

Conclusions: This position paper provides practical real-world guidelines resulting from a small survey of experienced users, for new and early uses of the novel 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser. J Drugs Dermatol. 2021;20(11):1150-1157. doi:10.36849/JDD.6181.
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November 2021

Cytrellis: A Novel Microcoring Technology for Scarless Skin Removal: Summary of Three Prospective Clinical Trials.

Plast Reconstr Surg Glob Open 2021 Oct 29;9(10):e3905. Epub 2021 Oct 29.

Skincare Physicians, Chestnut Hill, Mass.

Background: We introduce an innovative and novel technology that achieves scarless skin removal without the use of thermal energy. Microcoring technology (MCT) uses a modified, hollow hypodermic needle to remove skin safely and without a scar. This method is advantageous compared to other fractional devices, given that it has the same benefits as energy-based devices (removal of skin cores without a scar), with the added value of immediate closure along the relaxed skin tension lines, with significantly less thermal energy.

Methods: Three prospective clinical safety trials analyzing MCT treatment on abdominal and facial skin (short- and long-term) are described.

Results: MCT treatment of human skin resulted in scarless skin removal that was well tolerated by patients. Healing occurred rapidly, with limited side effects. Skin area reduction (skin tightening) and increase in skin thickness were observed long term.

Conclusions: MCT treatment of human skin is safe and well tolerated. Although further studies on efficacy are required to evaluate the full potential of MCT in skin rejuvenation, early findings such as skin tightening and increase in skin thickness are encouraging.
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October 2021

Clinical Evaluation of the Safety and Efficacy of a 1060-nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen.

Aesthet Surg J 2021 09;41(10):1155-1165

Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX, USA.

Background: Despite the proven efficacy of liposuction, there is a population of patients who prefer non-surgical alternatives. Laser hyperthermia-induced lipolysis has emerged as one non-invasive alternative to liposuction.

Objectives: The authors sought to evaluate the safety and efficacy of a 1060-nm (±10 nm) diode laser for non-invasive fat reduction of the abdomen.

Methods: This single-arm, 2-center study enrolled 30 patients. Patients received a 25-minute 1060-nm diode laser treatment on their abdomen. Ultrasound adipose measurements, body weight, and circumference were taken at baseline and at 6- and 12-week follow-up visits. Blinded evaluators identified "before" and "after" photos of each patient. A patient satisfaction questionnaire was completed by each patient at study exit.

Results: A total 29 patients completed all treatment and follow-up visits. Ultrasound images showed an adipose reduction of 8.55% at 12 weeks post-treatment (P < 0.0001). Blinded evaluators correctly identified 67% of the pre- and post-treatment images at site 01 (Sacramento, CA) and 56% at site 02 (Dallas, TX). Satisfaction was high, with 72% of patients reporting being either "satisfied" or "very satisfied" with their results on a 5-point Likert scale. Pain was rated as mild by 62% of patients, moderate by 38%, and severe by none on the Wong-Baker Scale.

Conclusions: These results indicate that a single treatment with a 1060-nm (±10 nm) diode laser, per the treatment protocol, is safe and effective in reducing unwanted fat in the abdomen as objectively measured employing ultrasound. The treatment was well-tolerated among all patients, with minimal discomfort reported and high patient satisfaction.

Level Of Evidence: 4:
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September 2021

Aesthetic Office Disaster Preparedness and Response Plan.

J Drugs Dermatol 2021 01;20(1):10-16

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.
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January 2021

Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring.

Dermatol Surg 2020 10;46 Suppl 1:S14-S21

Marina Plastic Surgery, Marina del Rey, California.

Background: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer.

Objective: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen.

Methods: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination. Electromagnetic muscle stimulation treatments were delivered in 4 sessions over 2 weeks. Cryolipolysis treatments were delivered in one session. Combination treatments consisted of one cryolipolysis and 4 EMMS visits. Efficacy was assessed by independent physician Global Aesthetic Improvement Scale (GAIS), circumferential measurement, Subject GAIS (SGAIS), and Body Satisfaction Questionnaire (BSQ).

Results: Safety was demonstrated for all study cohorts with no device- or procedure-related adverse events. Independent photo review showed greatest mean GAIS score for the Cryolipolysis + EMMS cohort followed by Cryolipolysis only, then EMMS only cohort. BSQ showed greatest average score increase for Cryolipolysis + EMMS cohort followed by Cryolipolysis only cohort, then EMMS only cohort. Mean circumferential reduction measurements were greatest for Cryolipolysis + EMMS cohort followed by Cryolipolysis only, and then EMMS only cohort. The mean SGAIS improvement score was equal for the Cryolipolysis only and Cryolipolysis + EMMS cohorts, followed by the EMMS only cohort.

Conclusion: A multimodal approach using cryolipolysis and EMMS was safe and demonstrated enhanced body contouring efficacy for this feasibility study.
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October 2020

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.

Dermatol Surg 2020 06;46(6):803-809

Pulse Biosciences, Inc., Hayward, California.

Background: Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis.

Objective: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH).

Methods: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs.

Results: At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss.

Conclusion: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs.

Trial Registration: NCT03612570.
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June 2020

Non-Surgical Fat Reduction and Topical Modulation of Adipose Tissue Physiology

J Drugs Dermatol 2019 Apr;18(4):375-380

Non-surgical fat reduction procedures have gained in popularity over the past few years and remain in great demand. The process results in accumulation of breakdown products, lipid droplets, that are slowly absorbed over a period of months. This paper outlines the physiological process whereby lipid droplets are absorbed through a process of autophagy (lipophagy) involving a repackaging of these droplets to smaller sizes so that macrophages can then cope with digestion of these very large particles. Furthermore, a fat compartment is described within the dermis surrounding the tail of the hair follicle, which is attracting much attention due to its unique phenotype, function, and connection to the deeper subcutaneous fat compartment. This provides an entry route for direct signaling to the subcutaneous fat. Related to these novel concepts, peptides can be designed in liposomal delivery systems to target lipid droplet breakdown via the hair follicle entry route. This concept is elucidated in this paper. J Drugs Dermatol. 2019;18(4):375-380.
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April 2019

An Observational Study of the Safety and Efficacy of Tissue Stabilized-Guided Subcision.

Dermatol Surg 2019 08;45(8):1057-1062

Ulthera, Inc.

Background: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance.

Methods: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study.

Results: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance.

Conclusion: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.
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August 2019

Self-reported Patient Motivations for Seeking Cosmetic Procedures.

JAMA Dermatol 2018 10;154(10):1167-1174

Wesson Dermatology, Great Neck, New York.

Importance: Despite the growing popularity of cosmetic procedures, the sociocultural and quality-of-life factors that motivate patients to undergo such procedures are not well understood.

Objective: To estimate the relative importance of factors that motivate patients to seek minimally invasive cosmetic procedures.

Design, Setting, And Participants: This prospective, multicenter observational study was performed at 2 academic and 11 private dermatology practice sites that represented all US geographic regions. Adult patients presenting for cosmetic consultation or treatment from December 4, 2016, through August 9, 2017, were eligible for participation.

Exposures: Participants completed a survey instrument based on a recently developed subjective framework of motivations and a demographic questionnaire.

Main Outcomes And Measures: Primary outcomes were the self-reported most common motivations in each quality-of-life category. Secondary outcomes were other frequently reported motivations and those associated with specific procedures.

Results: Of 529 eligible patients, 511 agreed to participate, were enrolled, and completed the survey. Typical respondents were female (440 [86.1%]), 45 years or older (286 [56.0%]), white (386 [75.5%]), and college educated (469 [91.8%]) and had previously received at least 2 cosmetic procedures (270 [52.8%]). Apart from motivations pertaining to aesthetic appearance, including the desire for beautiful skin and a youthful, attractive appearance, motives related to physical health, such as preventing worsening of condition or symptoms (253 of 475 [53.3%]), and psychosocial well-being, such as the desire to feel happier and more confident or improve total quality of life (314 of 467 [67.2%]), treat oneself or celebrate (284 of 463 [61.3%]), and look good professionally (261 of 476 [54.8%]) were commonly reported. Motivations related to cost and convenience were rated as less important (68 of 483 [14.1%]). Most motivations were internally generated, designed to please the patients and not others, with patients making the decision to undergo cosmetic procedures themselves and spouses seldom being influential. Patients younger than 45 years were more likely to undertake procedures to prevent aging (54 of 212 [25.5%] vs 42 of 286 [14.7%] among patients ≥45 years; P < .001). Patients seeking certain procedures, such as body contouring (19 of 22 [86.4%]), acne scar treatment (36 of 42 [85.7%]), and tattoo removal (8 of 11 [72.7%]), were more likely to report psychological and emotional motivations.

Conclusions And Relevance: This initial prospective, multicenter study comprehensively assessed why patients seek minimally invasive cosmetic procedures. Common reasons included emotional, psychological, and practical motivations in addition to the desire to enhance physical appearance. Differences relative to patient age and procedures sought may need further exploration.
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October 2018

Long-term clinical evaluation of hair clearance in darkly pigmented individuals using a novel diode1060 nm wavelength with multiple treatment handpieces: A prospective analysis with modeling and histological findings.

Lasers Surg Med 2018 09 30;50(9):893-901. Epub 2018 May 30.

Laser and Skin Surgery Center of Northern California, Sacramento Lumenis LTD, Sacramento, California.

Objective: The purpose of this study was to determine the efficacy and safety of a 1060 nm diode laser system with multiple handpieces for permanent hair reduction.

Study Design: An open-label, prospective, multi-center study of adult subjects (≥18 years old) of any skin type, having dark brown or black hairs at the areas to be treated and seeking to permanently remove hair underwent six treatment sessions, at 4 to 6 weeks intervals with either a 1060 nm chilled sapphire tip or seven treatment sessions, at 6 weeks interval with a large spot vacuum based handpiece.

Methods: Subjects received treatments on various body areas using chilled sapphire tip or large spot size vacuum-assisted handpiece. Hair counts as well as assessments of hair coarseness and color were performed using photographs taken at baseline, prior to pre-selected treatments and at the follow up visits. At every visit, immediate skin responses and adverse events were evaluated by the investigator and treatment associated pain level experienced was quantified by the subjects. Subjects were asked to assess their improvement and satisfaction at pre-selected treatment sessions and at all the follow up visits. A sub group of subjects that were treated with the large spot size vacuum-assisted handpiece contributed two punch biopsy specimens for histological analysis.

Results: A total of 16 subjects age 33 ± 10.9 years were treated with the chilled sapphire tip, and 26 subjects age 36.3 ± 7.67 years were treated with the large spot size vacuum-assisted handpiece. Treatment with chilled sapphire tip yielded a mean of 68%, 82%, and 76% skin type-independent hair reduction in axillae, shin, and arm, respectively, at 6 month follow up visit as compared to baseline. The majority of subjects (≥80%) rated their hair reduction to be either good or very good and were satisfied to highly satisfied with the outcome. Treatment with the large spot size vacuum-assisted handpiece, was most effective in axillae and calves, with a 77.9% and 78.5% hair count reduction, respectively, at the 6 month follow up visit. Subjects reported high satisfaction and improvement throughout the treatments and follow-up periods. Treatments with both handpieces were not associated with intolerable pain levels and common post procedural responses included mild to moderate erythema and/or edema.

Conclusion: The 1060 nm diode laser system is safe and effective for hair removal and long-term hair reduction in all skin types including darkly pigmented individuals. Lasers Surg. Med. 50:893-901, 2018. © 2018 Wiley Periodicals, Inc.
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September 2018

Lasers and Energy-Based Devices in Men.

Dermatol Surg 2017 Nov;43 Suppl 2:S176-S184

*Department of Dermatology, University of California, Davis, Sacramento, California; †Laser and Skin Surgery Center of Northern California, Sacramento, California; ‡Laser and Dermatologic Surgery Center, Chesterfield, Missouri.

Background: The demand for cosmetic treatments with lasers and energy-based devices has increased among men, but there is a dearth of literature that addresses the approach and treatment of cosmetic male patients.

Objective: To summarize common cosmetic concerns for which male patients seek cosmetic treatments and to provide sex-specific recommendations for the lasers and energy-based devices that can be used for treatment.

Materials And Methods: The authors conducted a literature search using the PubMed/MEDLINE and Google Scholar databases using the search terms male, men, gender, and cosmetic dermatology.

Results: The authors review sex-specific treatment recommendations regarding the use of lasers and energy-based devices for the conditions for which men most commonly seek cosmetic treatment, which include photo-/actinic damage, acne scarring, rhinophyma, hair removal, axillary hyperhidrosis, and loose neck/submental skin. Cosmetic issues the authors will touch on, but whose approaches or considerations vary less in men compared with women, are hyperpigmentation, vascular lesions, and facial rejuvenation.

Conclusion: Sex-specific treatment approaches with lasers and energy-based devices should be used to best serve male cosmetic patients.
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November 2017

ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use.

Dermatol Surg 2017 Oct;43(10):1249-1262

*Department of Dermatology, Northwestern University, Chicago, Illinois; †Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; ‡Section of Dermatology, University of Chicago Medicine, Chicago, Illinois; §SkinCare Physicians, Chestnut Hill, Massachusetts; ‖Laser & Skin Surgery Center of New York, New York, New York; ¶Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; #Union Square Laser Dermatology, New York, New York; **Laser and Skin Surgery Center of Northern California, Sacramento, California; ††Department of Dermatology, University of California Davis School of Medicine, Davis, California; ‡‡Department of Dermatology, University of California San Diego Health System, San Diego, California; §§DermOne, LLC, West Conshohocken, Pennsylvania; ‖‖Division of Dermatology, Section of Procedural Dermatology, Cooper University Health Care, Marlton, New Jersey; ¶¶Westlake Dermatology and Cosmetic Surgery, Austin, Texas; ##Division of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; ***Department of Dermatology, Naval Medical Center, San Diego, California; †††Department of Dermatology, Naval Hospital Camp Lejeune, Camp Lejeune, North Carolina; Departments of ‡‡‡Otolaryngology, and §§§Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

Background: Currently, the isotretinoin (13-cis-retinoic acid) package insert contains language advising the discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. It is common practice to follow this standard because of concerns regarding reports of sporadic adverse events and increased risk of scarring.

Objective: To develop expert consensus regarding the safety of skin procedures, including resurfacing, energy device treatments, and incisional and excisional procedures, in the setting of concurrent or recent isotretinoin use.

Materials And Methods: The American Society for Dermatologic Surgery authorized a task force of content experts to review the evidence and provide guidance. First, data were extracted from the literature. This was followed by a clinical question review, a consensus Delphi process, and validation of the results by peer review.

Results: The task force concluded that there is insufficient evidence to justify delaying treatment with superficial chemical peels and nonablative lasers, including hair removal lasers and lights, vascular lasers, and nonablative fractional devices for patients currently or recently exposed to isotretinoin. Superficial and focal dermabrasion may also be safe when performed by a well-trained clinician.
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October 2017

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

Dermatol Surg 2016 Oct;42(10):1164-73

*Department of Dermatology, McGaw Medical Center, Northwestern University, Chicago, Illinois; †SkinCare Physicians, Chestnut Hill, Massachusetts; ‡Dermatology Laser and Cosmetic Center, Massachusetts General Hospital, Boston, Massachusetts; §Department of Dermatology, University of Colorado School of Medicine, Aurora, Colorado; ‖Cosmetic Laser Dermatology-Goldman, Butterwick, Groff, Fabi & Wu, San Diego, California; ¶Westlake Dermatology and Cosmetic Surgery, Austin, Texas; #Laser & Skin Surgery Center of New York, New York, New York; **Skin Laser & Surgery Specialists of NY and NJ, Hackensack, New Jersey; ††Department of Dermatology, Mount Sinai School of Medicine, New York, New York; ‡‡Skin Associates of South Florida, Coral Gables, Florida; §§Department of Dermatology & Cutaneous Surgery, University of Miami, Coral Gables, Florida; ‖‖Connecticut Skin Institute, Stamford, Connecticut; ¶¶Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; ##Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, California; ***Laser and Skin Surgery Center of Northern California, Sacramento, California; †††McDaniel Laser and Cosmetic Center, Virginia Beach, Virginia; ‡‡‡Department of Dermatology, UPMC Cosmetic Surgery and Skin Health Center, University of Pittsburgh, Sewickley, Pennsylvania; §§§Laser and Cosmetic Dermatology, Department of Dermatology, University of California, San Diego, California; ‖‖‖Gateway Aesthetic Institute and Laser Center, Salt Lake City, Utah; ¶¶¶Department of Dermatology, Case Western Reserve University, MetroHealth Systems, Cleveland, Ohio; ###Department of Dermatology, University of South Florida, Tampa, Florida; ****Maryland Laser, Skin & Vein Institute, Hunt Valley, Maryland; ††††Hollywood Dermatology and Cosmetic Surgery Specialists, Hollywood, Florida; ‡‡‡‡Department of Otolaryngology, Feinberg School of Medicine, Nor

Background: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency.

Objective: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program.

Methods: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved.

Results: Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018.

Conclusion: Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.
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October 2016

Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference.

Suzanne L Kilmer

Lasers Surg Med 2017 01 21;49(1):63-68. Epub 2016 Jun 21.

Laser and Skin Surgery Center of Northern California, Sacramento, California.

Background And Objectives: Cryolipolysis is a safe, effective non-surgical procedure to reduce fat. For most cryolipolysis treatments, tissue is pulled between parallel cooling plates with a treatment duration of 60 minutes. A novel contoured cup, medium-sized applicator was developed to increase tissue contact with reduced skin tension and reduced treatment time. This prototype contoured cup was investigated with a standard cryolipolysis applicator to evaluate safety, efficacy, and patient preference.

Study Design/material And Methods: A prototype CoolCup medium-sized vacuum applicator (CoolSculpting System, ZELTIQ Aesthetics) was used to treat n = 19 subjects in the flanks. Randomly assigned, one flank received standard treatment with the CoolCore applicator (-10°C for 60 minutes). The contralateral flank received treatment from the CoolCup (-11°C for 35 minutes). The clinical study primary efficacy endpoint was 70% correct identification of baseline photographs by independent physician review. Incidence of adverse device effects was monitored. Fat layer reduction was measured by ultrasound and subject surveys were administered 12 weeks post-treatment.

Results: Equivalent efficacy was demonstrated between the CoolCore standard treatment and the prototype CoolCup. Independent review from three blinded physicians found 81% correct identification of baseline photographs for the standard treatment and 79% for the CoolCup. Ultrasound measurements indicated mean fat layer reduction of 4.38 mm for the standard treatment and 4.40 mm for the CoolCup; no statistically significant difference was found when comparing treatment efficacy of the two applicators (P = 0.96). Patient questionnaires revealed 85% preferred CoolCup because of shorter treatment duration and greater comfort. Procedural assessments revealed 45% lower pain scores for CoolCup. Immediate post-treatment clinical assessments revealed 82% less bruising. Typical side effects, such as numbness and erythema, were similar. There were no adverse events.

Conclusion: This clinical study of a prototype medium-sized vacuum applicator with a cooled contoured surface indicates that the CoolCup produces equivalent safety and efficacy to the standard CoolCore cryolipolysis applicator. With a 42% reduction in treatment time, the procedure was found to be more comfortable because of lower vacuum skin tension and shorter treatment duration. Lasers Surg. Med. 49:63-68, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.
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January 2017

Three-Dimensional Rejuvenation of the Décolletage.

Dermatol Surg 2016 May;42 Suppl 2:S101-7

*Suzanne Bruce and Associates, Houston and Katy, Texas; †Laser & Skin Surgery Center of Northern California, Sacramento, California.

Background: Photodamaged skin of the chest is characterized by skin laxity, lines/wrinkles, hyperpigmentation, erythema, tactile roughness, atrophy, and telangiectasias.

Methods: A MEDLINE search was performed on combination treatments in chest rejuvenation, and the results are summarized. Practical applications for these combinations of procedures are discussed.

Results: Reports of injectable poly-L-lactic acid (PLLA), hyaluronic acid (HA), and chemical peels, along with lasers and light therapies such as intense pulsed light (IPL), vascular lasers, photodynamic therapy (PDT), nonablative fractionated lasers (NAFLs), ablative fractionated lasers (AFLs), and microfocused ultrasound (MFU) have been reported for chest rejuvenation. Few articles were discovered pertaining to combination therapy. The authors review their approaches to combination therapy.

Conclusion: Multiple options exist alone or in combination for minimally invasive rejuvenation of the skin of the chest including PLLA, HA, chemical peels, IPL, vascular lasers, PDT, NAFL, AFL, and MFU. Little was found in the literature pertaining to the safety and efficacy of combining such procedures and devices. The authors' experience in clinical practice is that combination, same day chest rejuvenation techniques can be performed safely. A combination approach often produces the most optimal outcome for the patient seeking chest rejuvenation.
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May 2016

Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation.

Dermatol Surg 2015 Dec;41 Suppl 1:S293-301

*DeNova Research, Chicago, Illinois; †Suzanne Bruce and Associates, PA, Houston, Texas; ‡Laser & Skin Surgery Center of Northern California, Sacramento, California; §SkinCare Physicians, Chestnut Hill, Massachusetts; ‖Image Dermatology, Montclair, New Jersey; ¶Society Hill Dermatology, Philadelphia, Pennsylvania; #Peloton Advantage, LLC, Parsippany, New Jersey; **Allergan plc, Irvine, California.

Background: Hyaluronic acid gels are increasingly used for augmentation of the lips.

Objective: To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for augmentation of the lips.

Methods: This ongoing, multicenter, single-blind study randomized 213 subjects to the treatment group (n = 157) or concurrent no-treatment control group that received delayed treatment (n = 56). The primary effectiveness endpoint was the responder rate (≥1 point improvement from baseline) based on the blinded evaluating investigator's assessment of the subject's overall lip fullness (or fullness of the eligible lip) using the validated Allergan 5-point Lip Fullness Scale. To meet this endpoint, the treatment group had to have a responder rate ≥60% and significantly greater than the treatment control group at Month 3.

Results: The primary endpoint was met, with a 79.1% responder rate for the treatment group and 26.1% for the treatment control group (p < 0.0001). More than half of subjects (56.4%) maintained treatment response for 12 months. Common injection site responses were swelling, bruising, and firmness; most were of mild or moderate severity.

Conclusion: HYC-24L is safe and effective for aesthetic lip augmentation, with results lasting up to 1 year.
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December 2015

Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat.

Lasers Surg Med 2016 Jan 26;48(1):3-13. Epub 2015 Nov 26.

Zel Skin and Laser Specialists, Edina, Minnesota.

Background And Objectives: Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.

Study Design/material And Methods: A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at -10°C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device- and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.

Results: Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0 mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported.

Conclusion: The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.
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January 2016

A prospective multicenter pilot study of the safety and efficacy of microfocused ultrasound with visualization for improving lines and wrinkles of the décolleté.

Dermatol Surg 2015 Mar;41(3):327-35

*Goldman, Butterwick, Firtzpatrick, Groff & Fabi, Cosmetic Laser Dermatology San Diego, California; †Denova Research, Chicago, Illinois; ‡Tennessee Clinical Research Center, Nashville, Tennessee; §Laser and Skin Surgery Center of Northern California, Sacramento, California; ‖Apothekon, Inc., Woodbury, Minnesota.

Background: A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements.

Objective: To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population.

Materials And Methods: Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days.

Results: Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild.

Conclusion: A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.
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March 2015

Cryolipolysis for safe and effective inner thigh fat reduction.

Lasers Surg Med 2015 Feb 13;47(2):120-7. Epub 2015 Jan 13.

Zel Skin and Laser Specialists, Edina, Minnesota; University of Minnesota Medical School, Minneapolis, Minnesota.

Background And Objectives: While cryolipolysis initially received FDA clearance for fat reduction in the abdomen and flanks, there was significant interest in non-surgical fat reduction for other sites, such as the inner and outer thighs. This article reports the results of an inner thigh study which contributed to FDA clearance of cryolipolysis for treatment of thighs.

Study Design/material And Methods: A flat cup vacuum applicator (CoolFit applicator, CoolSculpting System) was used to treat 45 subjects bilaterally in the inner thighs. Single cycle treatments were delivered at Cooling Intensity Factor (CIF) 41.6 for 60 minutes followed by 2 minutes of manual massage. Follow-up visits were conducted at 8 and 16 weeks. Efficacy was assessed by ultrasound imaging, circumference measurements, and photographs. Safety was assessed by monitoring adverse events. Patient satisfaction was evaluated by questionnaire.

Results: Data is presented for n = 42 patients that completed the 16 week study follow-up and maintained their weight within 5 lbs. of baseline. Independent photo review from three blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicate fat layer reduction of 2.8 mm. Circumferential measurements indicate mean reduction of 0.9 cm. Patient questionnaires reveal 93% were satisfied with the CoolSculpting procedure; 84% noticed visible fat reduction; 89% would recommend to a friend; and 91% were likely to have a second treatment. There were no device- or procedure-related serious adverse events.

Conclusion: The CoolFit flat cup vacuum applicator was found to deliver safe and effective cryolipolysis treatment to reduce inner thigh fat. Completed 16-week data from 42 subjects show 2.8 mm reduction in fat thickness and 0.9 cm reduction in circumference. Assessment of clinical photographs found 91% correct identification of baseline images. The results of this prospective, multi-center, interventional clinical study contributed to FDA clearance of cryolipolysis for treatment of thighs in April 2014.
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February 2015

Bacterial infections following non-ablative fractional laser treatment: a case series and discussion.

Lasers Surg Med 2015 Feb 13;47(2):128-32. Epub 2015 Jan 13.

Department of Dermatology, Johns Hopkins University, 1550 Orleans Street, Suite 207, Baltimore, Maryland, 21231.

Non-ablative fractional laser procedures have become increasingly popular since their introduction in 2004. The fractional 1,927 nm thulium laser is a non-ablative device that penetrates up to 300 μm in the skin and the 1,550 nm erbium:glass laser penetrates up to 1,400 μm. These procedures are considered minimally invasive with a high safety profile; therefore, infectious complications are exceedingly rare. However, we report five recent cases of bacterial infection with both gram-positive and gram-negative organisms following treatment with the fractional 1550/1927 nm laser approximately 1 day to 1 week post-procedure. One patient had a rapidly progressing pustular eruption with symptoms of sepsis. These patients were seen immediately, cultures were obtained and empiric antibiotic therapy was initiated. They recovered without long-term complications. Rapid-onset bacterial infections following non-ablative laser resurfacing with the 1550/1927 nm laser have not been previously reported in the literature. The infections can progress quickly and lead to serious sequelae, including systemic illness and severe scarring, if not identified and appropriately treated. We present these cases to highlight the importance of close surveillance and when appropriate, rapid intervention, following non-ablative fractional procedures, especially when patients present with atypical symptoms and signs.
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February 2015

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

JAMA Dermatol 2015 Mar;151(3):271-7

Department of Biochemistry, Florida Atlantic University, Boca Raton.

Importance: Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date.

Objective: To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers.

Design, Setting, And Participants: A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation.

Exposures: Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form.

Main Outcomes And Measures: The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination.

Results: Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors.

Conclusions And Relevance: Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.
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March 2015

The new age of noninvasive facial rejuvenation.

Semin Cutan Med Surg 2013 Mar;32(1):53-8

Department of Dermatology, Mt. Sinai School of Medicine, New York, NY, USA.

The techniques of noninvasive facial rejuvenation are forever being redefined and improved. This article will review historical as well as present approaches to resurfacing, discussing the nonablative tools that can complement resurfacing procedures. Current thoughts on the pre- and postoperative care of resurfacing patients are also considered.
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March 2013

Mitomycin C in the treatment of keloids: a case and review.

J Drugs Dermatol 2013 Jun;12(6):701-3

Laser and Skin Surgery Center of Northern California, Sacramento, CA, USA.

Mitomycin C (MMC) is an antineoplastic antibiotic that has been used off-label in the treatment of hypertrophic scars and keloids. Herein we report our successful use of this agent in a patient with sternal keloids refractory to other means of therapy. We further review the literature regarding the use of MMC in the treatment of keloids.
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June 2013

Abbreviations for device names: a proposed methodology with specific examples.

Dermatol Surg 2013 Apr 22;39(4):548-50. Epub 2013 Feb 22.

American Society for Dermatologic Surgery, Rolling Meadows, IL 60611, USA.

Background: Many devices used in dermatology lack generic names. If investigators use commercial device names, they risk the appearance of bias. Alternatively, reliance on ad-hoc names and abbreviations may confuse readers who do not recognize these.

Objective: To develop a system for assigning abbreviations to denote devices commonly used in dermatology. Secondarily, to use this system to create abbreviations for FDA-approved neurotoxins and prepackaged injectable soft-tissue augmentation materials.

Methods: The American Society for Dermatologic Surgery convened a Lexicon Task Force in March 2012. One charge of this Task Force was to develop criteria for assigning abbreviations to medical devices. A modified consensus process was used.

Results: Abbreviations to denote devices were to be: based on a standardized approach; transparent to the casual reader; markedly brief; and in all cases, different than the commercial names. Three-letter all caps abbreviations, some with subscripts, were assigned to denote each of the approved neurotoxins and fillers.

Conclusion: A common system of abbreviations for medical devices in dermatology may avoid the appearance of bias while ensuring effective communication. The proposed system may be expanded to name other devices, and the ensuing abbreviations may be suitable for journal articles, continuing medical education lectures, or other academic or clinical purposes.
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April 2013

Prospective multicenter clinical trial of a minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid and laxity treatment.

Dermatol Surg 2013 Feb 28;39(2):263-73. Epub 2012 Dec 28.

School of Medicine, Yale University, New Haven, Connecticut, USA.

Background: A minimally invasive fractional bipolar radiofrequency (FRF) was developed.

Objective: To evaluate safety and efficacy of FRF in reducing face and neck rhytides and laxity.

Materials And Methods: This prospective, open-label, multicenter clinical trial enrolled 100 subjects with mild to severe facial and neck rhytides and laxity at seven centers in a per-protocol analysis. One single-pass FRF treatment was administered through five 32 g-needle electrode pairs at a preselected real-time fixed temperature of 62 to 78°C, energy duration for 3 to 5 seconds, and impedance restrictions of 200 to 3,000 Ohms, ensuring intradermal delivery. Five blinded dermatologists and plastic surgeons graded randomized standardized baseline and follow-up photographs of 53 and 42 subjects at 3- and 6-month follow-up intervals, respectively, using the Fitzpatrick wrinkle and Alexiades-Armenakas laxity scales. Subject assessments and adverse events were recorded in 100 subjects.

Results: Blinded evaluations revealed correct pre- and post-treatment identification in 100% of scored cases, mean improvement of 25.6% on the Fitzpatrick Wrinkle Scale and 24.1% on the Alexiades-Armenakas laxity scale at 6 months, and 100% response rate for rhytides and 95% for laxity. Subgroup analysis revealed maximal rhytid reduction in the mean target temperature of 66.7, energy duration of 4.2 seconds, and volume of denatured collagen of mm(3) denatured collagen group. Adverse events included transient erythema, edema, and ecchymoses, resolving within 1 to 5 days, and two incidents of temporary pinpoint depressions. More than 90% of subjects were satisfied or very satisfied.

Conclusion: Real-time temperature-controlled FRF is a highly reproducible, safe, effective nonsurgical treatment of face and neck rhytides and laxity and provides important insights into neocollagenesis, neoelastogenesis, and clinical outcomes.
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February 2013

Severe unilateral vasomotor rhinitis: an antecedent sign of vascular compromise?

Dermatol Surg 2012 Aug 5;38(8):1410-2. Epub 2012 Jun 5.

Laser and Skin Surgery Center of Northern California, Sacramento, California 95816, USA.

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August 2012