Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial.

BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.

Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial.

INTRODUCTION AND OBJECTIVES: Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. METHODS: Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. RESULTS: Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. CONCLUSION: A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned.

Wounding Therapies for Prevention of Photocarcinogenesis.

The occurrence of non-melanoma skin cancer (NMSC) is closely linked with advanced age and ultraviolet-B (UVB) exposure. More specifically, the development of NMSC is linked to diminished insulin-like growth factor-1 (IGF-1) signaling from senescent dermal fibroblasts in geriatric skin. Consequently, keratinocyte IGF-1 receptor (IGF-1R) remains inactive, resulting in failure to induce appropriate protective responses including DNA repair and cell cycle checkpoint signaling. This allows UVB-induced DNA damage to proliferate unchecked, which increases the likelihood of malignant transformation. NMSC is estimated to occur in 3.3 million individuals annually. The rising incidence results in increased morbidity and significant healthcare costs, which necessitate identification of effective treatment modalities. In this review, we highlight the pathogenesis of NMSC and discuss the potential of novel preventative therapies. In particular, wounding therapies such as dermabrasion, microneedling, chemical peeling, and fractionated laser resurfacing have been shown to restore IGF-1/IGF-1R signaling in geriatric skin and suppress the propagation of UVB-damaged keratinocytes. This wounding response effectively rejuvenates geriatric skin and decreases the incidence of age-associated NMSC.

A 12-Week, Prospective, Non-Comparative, Non-Randomized Study of Magnetic Muscle Stimulation for Improvement of Body Satisfaction With the Abdomen and Buttocks.

BACKGROUND AND OBJECTIVE: Magnetic muscle stimulation (MMS) is a relatively new energy-based technology that provides a non-invasive option for body contouring through stimulation and toning of underlying skeletal muscles. This study was conducted to examine the safety, efficacy, and body satisfaction scores of MMS using a CoolToneTM prototype for the aesthetic improvement of abdominal and buttock contour. STUDY DESIGN/MATERIALS AND METHODS: This was a prospective, non-comparative, non-randomized, 12-week, multicenter study. Male and female participants aged 22-65 years received 4 MMS treatment sessions to the abdomen and/or buttocks. Body Satisfaction Questionnaire (BSQ) scores for abdomen and/or buttocks were assessed at baseline, immediately post final treatment, at 4 weeks (primary endpoint), and 12 weeks post final treatment. Subject-rated Global Aesthetic Improvement Scale (SGAIS) was assessed at 4 weeks post final treatment (secondary endpoint), and 12 weeks post final treatment. Additional efficacy assessment included abdominal circumference obtained by 3D imaging at baseline, immediately post final treatment, and at 4 and 12 weeks post final treatment. A Subject Experience Questionnaire (SEQ) was used to assess treatment satisfaction and perspectives at 4 weeks and 12 weeks post final treatment. Adverse events (AEs) were monitored throughout the study. RESULTS: A total of 110 participants were recruited, who were 75% female, 80% Caucasian (mostly non-Hispanic), average age of 39.5 years (range 22-59) with an average body mass index (BMI) of 23.3 kg/m2 (range 18-29.9). At the 4-week post final treatment visit, the average BSQ score for participants receiving abdominal treatment (n = 93) was significantly improved with a 5.1 average increase in total score from baseline (possible score range 10-50) and by a 5.5 average increase from baseline for participants receiving buttocks treatment (n = 32) (p < 0.05). At 4 weeks post final treatment, the proportion of participants with SGAIS scores >"Improved" was 68.1% for participants receiving treatment of the abdomen (n = 94), and 81.8% for those receiving buttocks treatment (n = 33). The mean total decrease from baseline in waist circumference was significant at all time points. At the 12-week post final treatment visit, SEQ data revealed that a majority of participants were "Satisfied" or "Very Satisfied" with overall treatment results and "Agreed" or "Strongly Agreed" that they were motivated to maintain results either by working out or by additional treatment. A total of 6 AEs related to the device and/or treatment were reported, which resolved spontaneously during the study. CONCLUSION: Treatment of the abdomen and/or buttocks with MMS was well-tolerated and demonstrated significant improvement in aesthetic appearance through the 12-week post final treatment study duration. As a stand-alone treatment, MMS expands the range of options for individualized treatment planning for patients seeking abdominal and/or gluteal muscle toning. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

Hybrid Fractional Laser: A Multi-Center Trial on the Safety and Efficacy for Photorejuvenation

BACKGROUND: Laser skin resurfacing has continued to evolve over the past two decades. One of the most recent advances included a hybrid fractional laser resurfacing system that can sequentially utilize two wavelengths in its delivery, non-ablative coagulation with 1470 nm, and ablative vaporization with 2940 nm. The 1470 nm laser wavelength is absorbed by water, which is ideal for creating controlled zones of coagulation to chosen depths into the dermis up to 700 micrometers. The 2940 nm laser wavelength has a large water absorption coefficient, which results in precise ablation as desired in the epidermis up to 110 micrometers. This combination allows for fractionated non-ablative and ablative skin resurfacing simultaneously resulting in a cosmetic improvement in pigmentation, tone, texture of skin as well as other effects of photoaging. METHODS: Open-label prospective, multi-center study in which 34 female subjects were enrolled with Fitzpatrick skin types I-IV, mean age of 52 ± 14 years. Each subject underwent two treatments, spaced 4-6 weeks apart. Follow up visits at 1 week, 2 weeks, and 1, 2, and 3 months after the first treatment. Photographs, numeric pain scores during treatment, and subject satisfaction survey questionnaires were evaluated. Photographs were analyzed by six blinded evaluators. The primary endpoint was to evaluate safety and efficacy of hybrid laser treatments for photodamage and dyschromia. The secondary endpoints included evaluating the tolerability of the treatment using the Wong Baker Face scale and patient satisfaction survey results. RESULTS: Of the 29 subjects completing the study, 80% showed significant skin improvement on photographic analysis. Average numeric pain score was a 4 on a 0-10 scale. Survey results showed 100% satisfaction with treatment and achieved results. Two patients experienced post-inflammatory hyperpigmentation that resolved within 90 days. No other adverse events were reported. CONCLUSION: The non-ablative and ablative hybrid fractional laser can be used to safely and efficaciously treat photodamaged skin with high patient satisfaction and minimal adverse events. J Drugs Dermatol. 2018;17(11):1164-1168.

Self-reported Patient Motivations for Seeking Cosmetic Procedures.

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.

Noninvasive approach to treatment of submental fullness.

A recent survey done by the American Society for Dermatologic Surgery indicated that 67% of respondents were bothered by "excess fat under the chin/neck." Accumulation of fat in the preplatysmal compartment of the neck is a common cause for fullness in the submental area. In the past, surgical liposuction was the only option to remove fat in the submental area. Although effective, liposuction does have risks and downtime. Recently, noninvasive options for treatment of submental fat have been introduced. These include treatment with deoxycholic acid, known as Kybella®, and cryolipolysis using the CoolMini™ handpiece. Both of these treatments offer less downtime fewer potential risks than the surgical counterpart. This article summarizes these two procedures and describes noninvasive approaches to treatment of submental fat.

Isotretinoin and Timing of Procedural Interventions: A Systematic Review With Consensus Recommendations.

Importance: The notion that systemic isotretinoin taken within 6 to 12 months of cutaneous surgery contributes to abnormal scarring or delayed wound healing is widely taught and practiced; however, it is based on 3 small case series from the mid-1980s. Objective: To evaluate the body of literature to provide evidence-based recommendations regarding the safety of procedural interventions performed either concurrently with, or immediately following the cessation of systemic isotretinoin therapy. Evidence Review: A panel of national experts in pediatric dermatology, procedural/cosmetic dermatology, plastic surgery, scars, wound healing, acne, and isotretinoin was convened. A systematic PubMed review of English-language articles published from 1982 to 2017 was performed using the following search terms: isotretinoin, 13-cis-retinoic acid, Accutane, retinoids, acitretin, surgery, surgical, laser, ablative laser, nonablative laser, laser hair removal, chemical peel, dermabrasion, wound healing, safety, scarring, hypertrophic scar, and keloid. Evidence was graded, and expert consensus was obtained. Findings: Thirty-two relevant publications reported 1485 procedures. There was insufficient evidence to support delaying manual dermabrasion, superficial chemical peels, cutaneous surgery, laser hair removal, and fractional ablative and nonablative laser procedures for patients currently receiving or having recently completed isotretinoin therapy. Based on the available literature, mechanical dermabrasion and fully ablative laser are not recommended in the setting of systemic isotretinoin treatment. Conclusions and Relevance: Physicians and patients may have an evidence-based discussion regarding the known risk of cutaneous surgical procedures in the setting of systemic isotretinoin therapy. For some patients and some conditions, an informed decision may lead to earlier and potentially more effective interventions.

Is There a Gender-Specific Full Body Sagittal Profile for Different Spinopelvic Relationships? A Study on Propensity-Matched Cohorts.

DESIGN: Retrospective review. OBJECTIVE: To evaluate gender-related differences in compensatory recruitment to progressive sagittal malalignment. SUMMARY OF BACKGROUND DATA: Recent research has elucidated compensatory mechanisms recruited in response to sagittal malalignment, but gender-specific differences in compensatory recruitment patterns is unknown. METHODS: Single-center study of patients with full body x-rays. A female group was propensity matched by age, body mass index (BMI), and pelvic incidence (PI) to a male group. Patients were then stratified into five groups of progressive PI-lumbar lordosis (LL) mismatch (<0°, 0°-10°, 10°-20°, 20°-30°, >30°). Differences between PI-LL groups were assessed with analysis of variance, and between genders by unpaired t test. Knee flexion to pelvic tilt (PT) ratio was computed and compared between genders. Multivariate regression to develop predictive models for PT was performed for each gender, first with spinopelvic parameters and subsequently with inclusion of lower limb parameters. RESULTS: A total of 942 patient visits were included: 471 females (mean age 54 years, BMI 27, PI 51°) and 471 males (mean age 52 years, BMI 27, PI 51°). At the lowest level of malalignment, females had greater PT and less knee flexion. With progressive malalignment, females continued to exhibit a pattern of greater pelvic retroversion and less knee flexion compared to males. Hip extension was higher in females with progressive PI-LL mismatch groups. Both genders progressively recruited knee flexion and pelvic retroversion with increased PI-LL mismatch, except that at the higher PI-LL mismatch groups, only males continued to recruit knee flexion (all p < .05). Inclusion of lower limbs in the regression for PT markedly improved correlation coefficients for females but not for males. CONCLUSIONS: With progressive sagittal malalignment, men recruit more knee flexion and women recruit more pelvic tilt and hip extension. Knee flexion is a possible mechanism to gain pelvic tilt for females whereas for males, knee flexion is an independent compensatory mechanism.

Predicting Cervical Alignment Required to Maintain Horizontal Gaze Based on Global Spinal Alignment.

STUDY DESIGN: A retrospective cohort. OBJECTIVE: The aim of this study was to investigate the cervical alignment necessary for the maintenance of horizontal gaze that depends on underlying thoracolumbar alignment. SUMMARY OF BACKGROUND DATA: Cervical Sagittal Curve (CC) is affected by thoracic and global alignment. Recent studies suggest large variability in normative CC ranging from lordotic to kyphotic alignment. No previous studies have assessed the effect of global spinal alignment on CC in maintenance of horizontal gaze. METHODS: Patients without previous history of spinal surgery and able to maintain their horizontal gaze while undergoing full body imaging were included. Patients were stratified on the basis of thoracic kyphosis (TK) into (<30, 30-40, 40-50, and >50) and then by SRS-Schwab sagittal vertical axis (SVA) modifier into (posterior alignment SVA <0, aligned 0-50, and malaligned >50 mm). Cervical alignment was assessed among SVA grade in TK groups. Stepwise linear regression analysis was applied on random selection of 60% of the population. A simplified formula was developed and validated on the remaining 40%. RESULTS: In each TK group (n = 118, 137, 125, 197), lower CC (C2-C7) was significantly more lordotic by increased Schwab SVA grade. T1 slope and cervical SVA significantly increased with increased thoracolumbar (C7-S1) SVA. Upper CC (C0-C2) and mismatch between T1 slope and CC (T1-CL) were similar. Regression analysis revealed LL minus TK (LL-TK) as an independent predictor (r = 0.640, r = 0.410) with formula: CC = 10- (LL-TK)/2. Validation revealed that the absolute difference between the predicted CC and the actual CC was 8.5°. Moreover, 64.2% of patients had their predicted C2-C7 values within 10° of the actual CC. CONCLUSION: Cervical kyphosis may represent normal alignment in a significant number of patients. However, in patients with SVA >50 and greater thoracic kyphosis, cervical lordosis is needed to maintain the gaze. Cervical alignment can be predicted from underlying TK and lumbar lordosis, which may be clinically relevant when considering correction for thoracolumbar or cervical deformityLevel of Evidence: 3.

Comparison of 532 nm Potassium Titanyl Phosphate Laser and 595 nm Pulsed Dye Laser in the Treatment of Erythematous Surgical Scars: A Randomized, Controlled, Open-Label Study.

BACKGROUND: The pulsed dye laser (PDL) has long been used for treatment of erythematous and hypertrophic scars. Its effectiveness has been attributed in large part to its vascular-specificity. The vascular-specific potassium titanyl phosphate (KTP) laser has also been reported to be clinically effective for scars, but has not been compared to the PDL. OBJECTIVE: To compare the safety and clinical efficacy of a 532-nm KTP laser versus a 595-nm PDL in improving the appearance of erythematous surgical scars. METHODS: Twenty patients with matched bilateral erythematous surgical scars or a single linear erythematous scar measuring longer than 5 cm were enrolled in the study. Single scars were divided into equal halves with each half randomized to receive 3 successive treatments at 6-week intervals with either a 532-nm KTP laser (Excel V; Brisbane, CA) or a 595-nm PDL (Cynergy; Cynosure Inc., Chelmsford, MA) at equivalent laser parameters. Bilateral matched scars were similarly randomized to receive three 532-nm KTP or 595-nm PDL treatments. Clinical efficacy was evaluated 12 weeks after the third (final) laser treatment by independent, blinded photographic scar assessments. Secondary evaluations included final investigator and subject treatment/satisfaction assessments, Vancouver scar scale (VSS) scores, subject scar symptoms, intraoperative pain scores, and incidence of side effects. RESULTS: Clinical improvement of erythematous surgical scars was observed with both 532-nm KTP and 595-nm PDL systems. No statistically significant differences between the 2 treatment arms were noted in the independent, blinded photographic scar assessments, investigator and subject treatment/satisfaction assessments, subject scar symptoms, and intraoperative pain scores. The KTP arm produced statistically significant improvement for the vascularity component of the VSS only. Side effects were limited to mild treatment discomfort and minimal transient post-treatment erythema and purpura. No vesiculation, infection, scarring or other adverse events were experienced. Subject satisfaction surveys mirrored the observed clinical effects. CONCLUSION: The-532 nm KTP laser is comparable in efficacy and safety to the 595-nm PDL laser in the treatment of erythematous surgical scars.

Developing the Total Disability Index Based on an Analysis of the Interrelationships and Limitations of Oswestry and Neck Disability Index.

STUDY DESIGN: Retrospective. OBJECTIVE: This study assessed the feasibility of combining Oswestry and Neck Disability Index (ODI and NDI) into 1 shorter "Total Disability Index" (TDI) from which reconstructed scores could be computed. SUMMARY OF BACKGROUND DATA: ODI and NDI are not pure assessments of disability related to back and neck, respectively. Because of similarities/redundancies of questions, ODI scores may be elevated in neck-pain patients and the converse is true for NDI in back-pain patients. METHODS: Spine patients completed ODI and NDI, and complaints were recorded as back pain (BP), neck pain (NP), or both (BNP). Questionnaire scores were compared across cohorts via descriptives and Spearman (ρ) correlations. In exploring the feasibility of merging ODI/NDI, TDI was constructed from 9 ODI and 5 NDI items. Extracting questions from TDI, reconstructed 9-item rODI and 10-item rNDI indices were formed and compared with true ODI/NDI. RESULTS: There were a total of 1207 patients: 741 BP, 134 NP, and 268 BNP. Mean ODI was 37 ±â€Š21 and mean NDI was 32 ±â€Š21. Patients with concurrent BP and NP had significantly more disability. Seventy-eight patients of 134 (58%) patients with NP only had at least "moderate disability" by ODI and 297 of 741 (40%) patients with back pain only, had at least "moderate disability" by NDI. ODI versus NDI correlation was ρ = 0.755; ODI versus reconstructed rODI correlated at ρ = 0.985, and NDI versus reconstructed rNDI correlated at ρ = 0.967 (P < 0.01). CONCLUSION: Elevated ODI/NDI scores in patients with isolated complaints show that disability in 1 region affects scores on both surveys. This study constructed a 14-item TDI that represents every domain of ODI/NDI with exception of ODI "Sex Life." From this TDI, reconstructed scores correlated near perfectly with true scores. TDI provides a more global assessment of spinal disability and is a questionnaire that reduces the time burden to patients. The TDI allows for simultaneous assessment of back, neck, and global spinal disability.

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

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.

Microfocused ultrasound for skin tightening.

The demand for noninvasive skin tightening procedures is increasing as patients seek safe and effective alternatives to aesthetic surgical procedures of the face, neck, and body. Over the past decade, radiofrequency and infrared laser devices have been popularized owing to their ability to deliver controlled heat to the dermis, stimulate neocollagenesis, and effect modest tissue tightening with minimal recovery. However, these less invasive approaches are historically associated with inferior efficacy so that surgery still remains the treatment of choice to address moderate to severe tissue laxity. Microfocused ultrasound was recently introduced as a novel energy modality for transcutaneous heat delivery that reaches the deeper subdermal connective tissue in tightly focused zones at consistent programmed depths. The goal is to produce a deeper wound healing response at multiple levels with robust collagen remodeling and a more durable clinical response. The Ulthera device (Ulthera, Inc, Meza, AZ), with refined microfocused ultrasound technology, has been adapted specifically for skin tightening and lifting with little recovery or risk of complications since its introduction in 2009. As clinical parameters are studied and optimized, enhanced efficacy and consistency of clinical improvement is expected.

Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound.

BACKGROUND: Transcutaneous intense focused ultrasound is a novel Food and Drug Administration-approved technology for noninvasive skin tightening of the face and neck. No studies have reported on its safety and effectiveness on nonfacial areas. MATERIALS AND METHODS: Eighteen paired areas (6 each) on the upper arms, medial thighs, and extensor knees were randomly treated with two different transducers (4.0 MHz, 4.5-mm focal depth and 7.0 MHz, 3.0-mm focal depth). One side was randomly assigned to receive a single pass (single plane) of microthermal coagulation zones over the involved area with the 4.0 MHz, 4.5-mm-depth transducer, and the contralateral side was assigned to receive consecutive single passes (dual plane) using both transducers (4.0 MHz, 4.5-mm depth followed by 7.0 MHz, 3.0-mm depth). Two independent masked assessors determined clinical improvement scores using comparative standardized photographs obtained at baseline and 3 and 6 months after treatment. Subjective assessments of clinical improvement and side effects of treatment were obtained. RESULTS: Global assessment scores revealed significant improvement in all treated areas, with the upper arms and knees demonstrating more skin lifting and tightening than the thighs. Areas receiving dual-plane treatment had slightly better clinical scores than those receiving single-plane treatment in all three sites. Clinical scores from single-plane and dual-plane treated areas continued to improve between 3 and 6 months after treatment. Side effects were mild and transient and included erythema, warmth, and skin tenderness. Rare focal bruising was noted in two patients on the upper arms that resolved within 7 days. No other side effects were reported or observed. CONCLUSIONS: Transcutaneous intense focused ultrasound can be safely and effectively used to improve the clinical appearance (texture and contour) of the upper arms, extensor knees, and medial thighs.

Health-related quality of life of hematopoietic stem cell transplant childhood survivors: state of the science.

The notion of health-related quality of life (HRQoL) holds unique significance in the treatment of patients who have undergone hematopoietic stem cell transplantation (HSCT). Not only is transplant procedure inevitably associated with immediate and late medical effects along with high mortality and morbidity rates, but it can also significantly affect the HRQoL for the patient and family. This review of literature will assist advanced practice nurses and pediatric oncology nurses in distinguishing and targeting interventions for patients and families who are at high risk of encountering distress during and following HSCT. It provides information on the assessment of pre-HSCT variables to identify patient subgroups in need of more aggressive supportive care to improve HRQoL during transplant. Furthermore, it serves as a guideline for developing interventional strategies and the role of the advanced practice nurse and pediatric oncology nurse caring for the patient throughout and following transplant.

Combined 595-nm and 1,064-nm laser irradiation of recalcitrant and hypertrophic port-wine stains in children and adults.

PURPOSE: Although pulsed dye laser (PDL) treatment of port-wine stain (PWS) has long been proven safe and effective, incomplete clearance of these vascular malformations can be problematic. In addition, advanced PWS with deeper coloration and tissue hypertrophy can be particularly difficult to treat because of the superficial dermal penetration of 585- to 595-nm light. The purpose of this study was to evaluate the safety and efficacy of a novel device that delivers sequential pulses of 595- and 1,064-nm wavelengths in the treatment of recalcitrant and hypertrophic PWS. METHODS: Twenty-five children and adults (skin phototypes I-III) with recalcitrant or hypertrophic PWS showing incomplete clearance after 10 prior PDL treatments were included in the study. Successive treatments using a 595-nm PDL and a 1,064-nm neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser were delivered at 6- to 8-week intervals. Two masked assessors determined clinical improvement of treatment areas using independent evaluation of comparative photographs at baseline and 3 months after treatment using a standard quartile grading scale. RESULTS: The use of dual 595-/1,064-nm wavelengths provided continued improvement of PWS that were previously recalcitrant to ongoing PDL therapy. Side effects were limited to transient erythema, edema, and mild purpura. Rare vesicle formation was observed, with no subsequent scarring or undesirable pigmentary changes. CONCLUSION: The novel dual 595-nm PDL and 1,064-nm Nd:YAG laser is an effective treatment for PWS that are recalcitrant to PDL therapy alone.

Effect of a novel low-energy pulsed-light device for home-use hair removal.

BACKGROUND: Removal of unwanted hair is the most popular skin treatment worldwide. Over the past decade, various lasers and light sources for epilation have been advocated for use in an office setting, although most people continue to treat unwanted hair with a variety of temporary physical methods (e.g., waxing, shaving) in a home setting, presumably due to cost and convenience factors. OBJECTIVES: To evaluate the safety and efficacy of a low-energy pulsed-light device intended for home-use hair removal. MATERIALS AND METHODS: Twenty women (skin phototypes I-IV) with dark terminal hair in nonfacial sites (axilla, forearms, inguinal region, legs) self-administered three treatments at 2-week intervals using a handheld intense-pulsed-light device. Matched untreated skin sites were also studied. Hair counts and clinical photographs were obtained pretreatment and at 1, 3, and 6 months after the third treatment. Side effects and patient satisfaction scores were recorded. RESULTS: All patients showed a positive clinical response to treatment, with reduction of unwanted hair. No reduction of hair was noted in untreated matched areas. Hair counts were reduced 37.8% to 53.6% 6 months after the three treatments. Skin region influenced clinical response, with lower legs exhibiting greater hair reduction than arms and inguinal and axillary areas. Mild erythema was experienced in 25% of patients, but no other side effects or complications were encountered. Patient satisfaction scores were high, with all patients stating that they would purchase the device for future home use. CONCLUSIONS Low-energy pulsed light can be applied safely and effectively for at-home hair removal in a variety of nonfacial locations and skin phototypes I-IV.

Photopneumatic therapy for the treatment of acne.

BACKGROUND: A wide variety of laser and light-based therapies have been utilized for acne vulgaris; however, current techniques have been limited by photosensitivity issues or inconsistent results. OBJECTIVE: To determine the clinical efficacy and side-effect profile of photopneumatic therapy for the treatment of facial acne vulgaris. METHODS: Twenty adults with mild to severe facial acne vulgaris received 4 successive treatments at 2-week intervals with a combined photopneumatic device (intense pulsed light [IPL]: fluences = 3.6-4.2 J/cm2; negative pressure = 3 psi). Clinical improvement was evaluated on a quartile grading scale using comparative digital photographs at baseline, and 1 month and 3 months after the final treatment. Acne lesion counts were obtained at baseline, prior to each treatment session, and at the end of the study. RESULTS: Modest reduction in acne lesion counts and global clinical improvement was seen in the majority of patients. Patients with severe acne experienced the most clinical improvement. Side effects were mild and limited to transient erythema and rare purpura. Most patients experienced acne worsening early in the treatment course. CONCLUSION: Photopneumatic therapy is a safe and effective treatment for acne vulgaris. Patients with more severe acne respond best to treatment.

Fraxel laser indications and long-term follow-up.

Fractional photothermolysis, based on creating spatially precise microscopic thermal wounds, is performed using a 1550-nm erbium fiber laser that targets water-containing tissue to effect the photocoagulation of narrow, sharply defined columns of skin known as microscopic thermal zones. According to the authors, Fraxel resurfacing has been shown to be both safe and effective for facial and nonfacial photodamage, atrophic acne scars, hypopigmented scars, and dyspigmentation. Because only a fraction of the skin is treated during a single session, a series (typically 3 to 6 treatments) of fractional resurfacing at 2- to 4-week intervals is required for the best clinical improvement. It is the authors' experience that a series of Fraxel treatments can achieve a similar clinical result for atrophic scars compared with traditional ablative laser skin resurfacing. However, the improvement seen after a series of Fraxel treatments for perioral laxity and rhytides often falls short of the impressive results that can be achieved with ablative laser skin resurfacing.