Clinical evaluation of the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the flanks.

BACKGROUND: Laser hyperthermia-induced lipolysis is a non-invasive method of localized fat treatment. Non-invasive approaches could be an option for a growing number of patients who are risk-averse and are seeking out non-invasive alternatives to surgical procedures such as liposuction. This study evaluated the safety and efficacy of a 1060 nm diode laser for the non-invasive fat reduction of the flanks. METHODS: A total of 30 subjects were enrolled in this prospective, single center study. Subjects received one 25-min treatment with a 1060 nm diode laser to both flanks. Follow-up visits were conducted at 6 and 12 weeks after the last treatment. Ultrasound adipose thickness, body weight, and circumference measurements were taken at baseline and at the 6- and 12-week follow-up visits. Subject satisfaction was assessed using a self-assessment of fat reduction, pain, and tolerability scales, and a subject satisfaction questionnaire. Safety was assessed via the presence or absence of any adverse events. RESULTS: The average age of subjects was 47.3 years. A total of 27 subjects completed the treatment and returned for both follow-up visits. An adipose reduction of 7.57 ± 1.15% at 6 weeks post-treatment (p < 0.0001) was measured using ultrasound. High subject satisfaction was seen, with 74% of subjects reporting being either "satisfied" or "very satisfied" with their results on a 5-point Likert Scale. Eighty-two percent of subjects stated they would recommend the treatment to their friends. All subjects had either mild or moderate pain, with 52% of subjects rating their pain as "mild" (1-3), while 48% rated their pain as moderate (4-7) on the Wong-Baker Scale. CONCLUSIONS: A single treatment with a 1060 nm diode laser was both safe and effective in reducing unwanted fat in the flanks without any unanticipated adverse events. Subjects described their treatment pain as mild or moderate and were highly satisfied with their treatment outcomes.

Postoperative Mechanomodulation Decreases T-Junction Dehiscence After Reduction Mammaplasty: Early Scar Analysis From a Randomized Controlled Trial.

BACKGROUND: Soft tissue and cutaneous tension is an important contributor to complicated wound healing and poor scar cosmesis after surgery and its mitigation is a key consideration in aesthetic and reconstructive procedures. OBJECTIVES: The study objective was to assess the efficacy of the force modulating tissue bridge (FMTB) ("Brijjit", Brijjit Medical Inc., Atlanta, GA) in reducing mechanical tension on postoperative wounds. METHODS: A prospective, single-center, randomized, within-subject clinical trial was conducted to evaluate wound healing and nascent scar formation after 8 weeks of postoperative wound support with the FMTB. Patients received standard of care (SOC) subcuticular closure on the vertical incision of 1 breast and experimental closure with the FMTB on the contralateral incision after Wise-pattern reduction mammaplasty. Three-dimensional wound analysis and rates of T-junction dehiscence were evaluated by clinical assessment at 2, 4, 6, and 8 weeks postsurgery. RESULTS: Thirty-four patients (n = 68 breasts) completed 8 weeks of postoperative FMTB application. There was a reduced rate of T-junction wound dehiscence in FMTB breasts (n = 1) vs SOC breasts (n = 11) (P < .01). The mean vertical incision wound area during the intervention period was significantly decreased in the FMTB breast (1.5 cm2) vs the SOC breast (2.1 cm2) (P < .01) and was significantly lower at 2-, 4-, and 8-week follow-up (P < .01). Only the closure method was significantly associated with variations in Week 8 wound area (P < .01) after linear regression modeling. CONCLUSIONS: FMTBs decrease nascent scar dimensions and reduce the occurrence of wound dehiscence. This study provides evidence that the use of continuous mechanomodulation significantly reduces postoperative wound complications after skin closure.

Investigating the Efficacy of Modified Lipoaspirate Grafting to Improve the Appearance of Atrophic Acne Scars: A Pilot Study.

BACKGROUND: Processed lipoaspirate grafting describes several techniques theorized to leverage the inflammatory and regenerative capacities of mechanically processed adipocytes to rejuvenate and correct skin pathology. Although lipoaspirate grafting is typically leveraged to fill visible defects such as depressed scars and dermal lines, additional fat processing allows grafts to stimulate mechanisms of wound healing, including the promotion of fibroblast activation, neovascularization, and neocollagenesis. OBJECTIVES: This study intends to assess the efficacy and tolerability of processed lipoaspirate grafting monotherapy to improve the clinical appearance of atrophic acne scars. METHODS: Patients underwent a single autologous processed lipoaspirate grafting procedure at the site of atrophic acne scars. Objective and subjective scar analysis was performed at 3 and 6 months posttreatment. Scars were assessed with standard photography, topographic analysis, and noninvasive skin measurements. In addition, microbiopsies were obtained before and after treatment to assess histological or genetic changes. Clinical improvement was assessed with patient and clinician Global Aesthetic Improvement Scales (GAIS) and blinded photographic evaluation. RESULTS: Ten patients between ages 18 and 60 completed the study. Clinical evaluation demonstrated that fat grafting improved the appearance of atrophic acne scars. Clinician GAIS and patient GAIS scores showed clinical improvement at both 3- and 6-month follow-up compared with baseline (P < .05). Blinded clinician GAIS scores also showed statistically significant improvement when clinicians compared clinical photographs taken at 6-month follow-up to baseline (P < .0001). The attenuation coefficient increased at 6-month follow-up, suggesting collagen remodeling and reorganization over the study period. Patients experienced anticipated posttreatment symptoms including transient erythema and edema; however, no unexpected adverse events were reported. CONCLUSIONS: Micronized lipoaspirate injection is a viable and effective option to improve the appearance of facial acne scarring. Favorable improvements in atrophic acne scarring were captured by objective analysis of skin ultrastructure as well as improvement in subjective assessments of scarring.

Investigating the efficacy of a fractionated 1927 nm laser for diffuse dyspigmentation and actinic changes.

OBJECTIVES: Facial actinic irregularities are frequent targets for noninvasive, energy-based treatment. These irregularities are multifactorial and driven by both intrinsic factors such as aging, genetics, and hormone exposure, and extrinsic factors, such as UV exposure. Clinically, this photodamage manifests as dyschromic skin disorders like melasma and actinic features such as solar lentigines. Fractionated 1927 nm (f1927 nm) nonablative lasers are suitable for targeting epidermal lesions and have been shown to be effective in resurfacing photoaged skin as well as addressing pigmented lesions without exacerbation. The purpose of this study was to quantify the magnitude and duration of actinic pigment and photodamage response in patients of Fitzpatrick Skin Phototypes (SPT) I-IV who underwent two treatments with a fractionated, nonablative 1927 nm thulium laser (MOXI™, Sciton). METHODS: The authors conducted an IRB-approved, single-center, prospective, nonrandomized study to evaluate the efficacy of f1927 nm nonablative lasers in the treatment of diffuse dyspigmentation and actinic irregularities. Patients underwent two treatments with f1927 nm nonablative laser at a 1-month interval. F1927 nm treatment and energy parameters included a pulse energy of 15 mJ, density of 15% with 15% coverage, and six total passes. The primary endpoint for this study was pigment response after treatment, measured using the VISIA Skin Imaging and Analysis System (Canfield Scientific). Pigmentary lesions measured and analyzed included spots, UV spots, and brown spots. The Physician's Global Assessment Scale was used by plastic surgeons to provide a subjective clinical assessment of melasma response. Nonparametric testing was used to assess and compare VISIA results across the study period as well as clinician evaluations. A p value ≤ 0.05 was considered statistically significant. RESULTS: Twenty-seven patients underwent two treatments with nonablative, f1927 nm laser in May and June 2022. Ninety-six percent of patients (n = 26) completed 1-month follow-up and 89% of patients (n = 24) completed 3-month follow-up. The study cohort was 100% female, with a mean ± SD age of 47.0 ± 11.5 (range: 29-74), and a mean Fitzpatrick SPT of 2.8 (range: I-IV). No serious adverse events were observed during study treatment or follow-up. Overall, analysis showed statistically significant improvements in dyspigmentation at 1 month and an increase in pigment toward baseline at 3 months. At 1 month, there was a statistically significant decrease in spots (p = 0.002), UV spots (p < 0.001), and brown spots (p < 0.001) compared to baseline. At 3 months, Brown spots remained significantly improved compared to baseline (p = 0.05). Analysis showed 9.9% improvement in pigment on the left (p < 0.0001) and 7.5% improvement in pigment on the right (p < 0.0001) face. Right dyspigmentation remained significantly improved at 3-month follow-up (p = 0.02). Subjectively, clinician evaluators' mean Physician's Global Assessment Scale score was 3.4 (p < 0.0001) at 1-month follow-up and 3.7 (p < 0.0001) at 3-month follow-up, which correspond to an approximately 50% improvement hyperpigmentation when at both time points. CONCLUSION: These results demonstrate that fractionated, nonablative 1927 nm laser treatment is an effective modality for improving clinical and subclinical photodamage. The magnitude and duration of pigment improvement are potentially influenced by the propensity for photodamage during the summer months, which may suggest the need for multiple f1927 nm treatments over time to maintain results.

Evaluation and characterization of facial skin aging using optical coherence tomography.

OBJECTIVES: The skin aging exposome encompasses internal and external factors that contribute to clinical signs of facial aging. Aging skin can be characterized by distinctive features such as wrinkles, lentigines, elastosis, and roughness. Optical coherence tomography (OCT) is capable of noninvasively measuring skin characteristics. This study aimed to assess bilateral features using OCT to explore temporal skin changes among decades and potential changes in facial skin aging based on laterality. METHODS: A total of 97 subjects between 20 and 89 years old with Fitzpatrick skin types I to IV were enrolled. VivoSight, a Multi-Beam OCT system intended to gather topographical and histological images of skin, was used to scan the area inferolateral to the lateral canthus, bilaterally. Investigators compared characteristics of skin roughness, attenuation coefficient and blood flow across age groups and based on laterality to determine any differences. RESULTS: Only data from successful OCT scans were used. Seventy subjects, 10 from each specified decade, had successful bilateral scans and were thus included in the analysis. Chronological aging was characterized by significantly decreased dermal attenuation coefficient with increased age. Skin roughness measurements showed trends of increased roughness with age; however, no statistically significant changes were seen between groups. Qualitative differences amongst scans taken on right and left sides of the face showed no significance regarding roughness, density or blood flow at depths ranging from 0.05 to 0.5 mm. CONCLUSIONS: OCT is an effective method for evaluating changes in aging skin. Our results illustrate a decline in skin density with chronological age. Additionally, it was illustrated that structural change in the epidermis and dermis does occur, however on a microscopic scale, there are no significant differences based on laterality. OCT holds promise as a noninvasive technique for characterization of aging skin. Its utility and application in the clinical management and treatment of aged skin requires further research; however, the technology has potential to personalize therapies based on objective findings.

The Efficacy of Intense Pulsed Light as a Treatment for Benign Pigmented Lesions on the Dorsal Hand.

BACKGROUND: Intense pulsed light (IPL) is a noninvasive therapeutic option to treat benign pigmented lesions by targeting melanin. OBJECTIVE: The purpose of this study was to assess IPL as a treatment for benign pigmented dorsal hand lesions. MATERIALS AND METHODS: A total of fifteen subjects, 40 to 73 years old, received 3 monthly IPL treatments over the dorsal hands. Subjects followed up 1 and 3 months after treatment. At every visit, photographs were taken using the VISIA Complexion Analysis System (Canfield Scientific, Fairfield, NJ) and analyzed using the RBX Brown Spots Analysis algorithm. The Clinician Global Aesthetic Improvement Scale and Subject Global Aesthetic Improvement Scale were completed at both follow-up visits. RESULTS: A total of fifteen subjects completed all six visits. The number of brown spots decreased 9.26% ( p = .0004) and 7.52% ( p = .0132) at each follow-up visit. The mean brown intensity decreased 6.15% ( p = .0183) and 7.67% ( p = .0178), whereas the mean contrast intensity decreased 8.88% ( p < .0001) and 6.60% ( p = .0007) 1 and 3 months after treatment, respectively. The mean Clinician Global Aesthetic Improvement Scale was 2.03 and 2.23, whereas the mean Subject Global Aesthetic Improvement Scale 1 and 3 months after treatment was 1.6 and 1.8, respectively. CONCLUSION: Objective analysis, along with clinician and subject assessments, showed an improvement in the appearance of benign pigmented lesions in the treated area after 3 IPL treatments.

A Randomized, Placebo-Controlled Trial Evaluating the Single and Combined Efficacy of Radiofrequency and Hybrid Fractional Laser for Nonsurgical Aesthetic Genital Procedures in Post-Menopausal Women.

BACKGROUND: The efficacy of interventions that provide long-term relief of genitourinary symptoms of menopause has not been determined. OBJECTIVES: The authors sought to evaluate radiofrequency and hybrid fractional laser (HFL) treatments for menopausal vulvovaginal symptoms. METHODS: Thirty-one postmenopausal women completed all treatments and at least 1 follow-up. Outcomes included the Vulvovaginal Symptom Questionnaire (VSQ), Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form, Incontinence Impact Questionnaire (IIQ), Female Sexual Function Index (FSFI), laxity measurements via a vaginal biometric analyzer probe, and gene expression studies. RESULTS: Mean VSQ score decreased 2.93 (P = 0.0162), 4.07 (P = 0.0035), and 4.78 (P = 0.0089) among placebo, dual, and HFL groups 3 months posttreatment and decreased to 3.3 (P = 0.0215) for dual patients at 6 months. FSFI scores increased in the desire domain for placebo and dual groups and in arousal, lubrication, orgasm, satisfaction, and pain domains for the HFL group 3 and 6 months posttreatment. An increase of 1.14 in VLQ score (P = 0.0294) was noted 3 months and 2.2 (P = 0.002) 6 months following dual treatment. There was also a mean decrease of 15.3 (P = 0.0069) in IIQ score for HFL patients at 3 months. Dual, HFL, and RF treatments resulted in statistically significant decreases in collagen I, elastin, and lysyl oxidase expression. CONCLUSIONS: Several self-reported improvements were noted, particularly among HFL, dual, and placebo groups 3 and 6 months posttreatment. Objective biopsy analysis illustrated decreased gene expression, suggesting that treatments did not stimulate new extracellular matrix production.

A Single-Center Pilot Study to Classify Signs of Dorsal Hand Aging Using 3 Grading Scales.

BACKGROUND: While validated scales must be created in order to systemically evaluate patients and quantify outcomes of aesthetic hand treatments, scales currently available are limited to the analysis of volume loss alone. OBJECTIVES: The purpose of this study was to develop 3 validated scales for the assessment of dorsal hand aging that also take into consideration wrinkling and pigmentation. METHODS: Fifty (50) healthy volunteers (40 females and 10 males) with Fitzpatrick skin types I-IV were recruited, and standard photographs of their left and right dorsal hands were taken with a Nikon D7100 (Nikon; Minato, Tokyo, Japan) camera. Using 25 randomized photographs, 11 plastic surgery physicians (3 chief residents, 6 senior residents, and 2 aesthetic surgery fellows) were trained on the 3 scales under investigation as well as the already-validated Merz Hand Grading Scale (MHGS). The evaluators then viewed the remaining 75 photographs independently and assigned a grade for each of the 4 scales to each photograph. Inter-rater variability was calculated for each scale. RESULTS: The Kappa score for the MHGS was 0.25, indicating fair agreement; 0.40 for wrinkle scale, indicating fair agreement; and 0.48 and 0.46 for the pigmentation density and intensity scales, respectively, indicating moderate agreement (P < 0.001). CONCLUSIONS: The results show that after receiving training, the inter-rater agreement for the 3 scales under investigation was similar or slightly higher than that for the MHGS. These 3 photographic classification systems can be used consistently and reliably to characterize multiple signs of dorsal hand aging.

A Single-Center Trial to Evaluate the Efficacy and Tolerability of Four Microneedling Treatments on Fine Lines and Wrinkles of Facial and Neck Skin in Subjects With Fitzpatrick Skin Types I-IV: An Objective Assessment Using Noninvasive Devices and 0.33-mm Microbiopsies.

BACKGROUND: Although ablative techniques are the standard of care for the treatment of fine lines and wrinkles, microneedling offers a minimally invasive alternative. OBJECTIVES: The purpose of this study was to assess the efficacy of microneedling on facial and neck fine lines and wrinkles. METHODS: Thirty-five subjects between 44 and 65 years old with Fitzpatrick skin types I to IV received 4 monthly microneedling treatments over the face and neck. Subjects returned 1 and 3 months posttreatment. At every visit, high-resolution ultrasonography and optical coherence tomography were performed, and transepidermal water loss and skin elasticity were measured. Microbiopsies (0.33 mm) were collected pretreatment, before the fourth treatment and 3 months posttreatment. RESULTS: Thirty-two subjects (30 females, 2 males) completed all 7 visits. Facial dermal and epidermal density increased 101.86% and 19.28%, respectively, from baseline at 3 months posttreatment. Facial elasticity increased 28.2% from baseline at 3 months posttreatment. Facial attenuation coefficient increased 15.65% and 17.33% at 1 and 3 months posttreatment, respectively. At study completion, blood flow at a depth of 300 µm decreased 25.8% in the face and 42.3% in the neck. Relative collagen type III and elastin gene expression was statistically higher 3 months posttreatment. However, total elastin protein levels were unchanged from baseline values. Dermal muscle formation was observed in 58% of biopsies extracted 3 months posttreatment compared with 15.3% at baseline. CONCLUSIONS: The results illustrate the effects of microneedling treatments. Noninvasive measurements and biopsy data showed changes in skin architecture and collagen/elastin gene expression, suggesting skin rejuvenation, with new extracellular matrix production and muscle formation.

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

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.

Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research.

BACKGROUND: Critical illness research is challenging due to disease severity and because patients are frequently incapacitated. Surrogates called upon to provide consent might not accurately represent patient preferences. Though commonplace, genetic data collection adds complexity in this context. We undertook this investigation to understand whether surrogate decision makers would be receptive to permitting participation in a critical illness genetics study and whether their decision making was consistent with that of the patient represented. METHODS: We invited individuals identified as surrogates for critically ill adults, if required, as well as patients once recovered to participate in a survey designed to understand attitudes about genetic research. Associations between dependent (receptivity to participation, concordance of responses) and independent variables were tested using bivariate and multivariate logistic regression analyses. RESULTS: Most of the entire surrogate sample (n=439) reported familiarity with research, including genetic research; tended to view research as useful; and were receptive to allowing their family member participate (with 39.6% and 38.1% stating that this would be "very" and "somewhat likely," respectively) even absent direct benefit. Willingness to participate was similar comparing genetic and non-genetic studies (χ2 [1,n=439]=0.00127, p=0.972), though respondents expressed worry regarding lack of confidentiality of genetic data. Responses were concordant in 70.8% of the 192 surrogate-patient pairs analyzed. In multivariate analysis, African American race was associated with less receptivity to genetic data collection (p<0.05). No factors associated with concordance of surrogate-patient response were identified. CONCLUSIONS: Surrogates' receptivity to critical illness research was not influenced by whether the study entailed collection of genetic data. While more than two-thirds of surrogate-patient responses for participation in genetics research were concordant, concerns expressed regarding genetic data often related to breach of confidentiality. Emphasizing safeguards in place to minimize such breeches might prove an effective strategy for enhancing recruitment.

Detection of neurofilament-H in serum as a diagnostic tool to predict injury severity in patients who have suffered mild traumatic brain injury.

OBJECT: In previous studies of traumatic brain injury (TBI), neural biomarkers of injury correlate with injury severity and predict neurological outcome. The object of this paper was to characterize neurofilament-H (NFL-H) as a predictor of injury severity in patients who have suffered mild TBI (mTBI). Thus, the authors hypothesized that phosphorylated NFL-H (pNFL-H) levels are higher in mTBI patients than in healthy controls and identify which subjects experienced a more severe injury such as skull fractures, intracranial hemorrhaging, and/or contusions as detected by CT scans. METHODS: In this prospective clinical study, blood (8 ml) was collected from subjects (n = 34) suffering from mTBI (as defined by the American Congress of Rehabilitation and Glasgow Coma Scale scores between 13 and 15) at Parkland Hospital, Dallas, Texas, on Days 1 and 3 after injury). Additional clinical findings from the CT scans were also used to categorize the TBI patients into those with and those without clinical findings on the scans (CT+ and CTgroups, respectively). The serum levels of pNFL-H were measured using the enzyme-linked immunosorbent assay. RESULTS: Compared with healthy controls, the mTBI patients exhibited a significant increase in the serum levels of pNFL-H on Days 1 (p = 0.00001) and 3 (p = 0.0001) after TBI. An inverse correlation was observed between pNFL-H serum levels and Glasgow Coma Scale scores, which was significant. Additionally, using receiver operating characteristic curve analysis to compare the mTBI cases with controls to determine sensitivity and specificity, an area under the curve of 100% was achieved for both (p = 0.0001 for both). pNFL-H serum levels were only significantly higher on Day 1 in mTBI patients in the CT+ group (p < 0.008) compared with the CT- group. The area under the curve (82.5%) for the CT+ group versus the CT- group was significant (p = 0.021) with a sensitivity of 87.5% and a specificity of 70%, using a cutoff of 1071 pg/ml of pNFL-H in serum. CONCLUSIONS: This study describes the serum profile of pNFL-H in patients suffering from mTBI with and without CT findings on Days 1 and 3 after injury. These results suggest that detection of pNFL-H may be useful in determining which individuals require CT imaging to assess the severity of their injury.

Considerations in the construction of an instrument to assess attitudes regarding critical illness gene variation research.

Clinical studies conducted in intensive care units are associated with logistical and ethical challenges. Diseases investigated are precipitous and life-threatening, care is highly technological, and patients are often incapacitated and decision-making is provided by surrogates. These investigations increasingly involve collection of genetic data. The manner in which the exigencies of critical illness impact attitudes regarding genetic data collection is unstudied. Given interest in understanding stakeholder preferences as a foundation for the ethical conduct of research, filling this knowledge gap is timely. The conduct of opinion research in the critical care arena is novel. This brief report describes the development of parallel patient/surrogate decision-maker quantitative survey instruments for use in this environment. Future research employing this instrument or a variant of it with diverse populations promises to inform research practices in critical illness gene variation research.