Unlocking the psycho-social-dermal axis: A double blinded randomized placebo controlled study unveiling the influence of a novel topical formulation on skin quality, attractiveness, quality of life, and sexual satisfaction.

BACKGROUND: Improved skin appearance is closely linked to higher self-esteem, favorable first impressions, and enhanced quality of life, with skincare products often being formulated with biostimulatory and regenerative ingredients to both enhance skin health and provide psychological benefits. Certain components, such as phospholipids and botanicals, may not only improve skin quality, but also impact mood, romantic bonding, and sexual attraction. AIMS: To assess whether a novel topical skin care product formulated with a proprietary combination of proteins, lipids, and botanical derivatives, can potentially result in a robust psycho-social-dermatological benefit via modulation epidermal oxytocin and pheromonal pathways. PATIENTS/METHODS: In this single-center prospective, randomized, controlled, double-blinded study, 40 female subjects were randomly assigned to use of either active novel skincare products, or placebos, for 4-8 weeks. Skin assessments, standardized photography, first impression ratings, and questionnaires on confidence and sexual satisfaction were conducted. RESULTS: Thirty-nine subjects completed the study and demonstrated a statistically significant improvement in skin quality following 4 and 8 weeks of use, with improvements of greater magnitude demonstrated with a longer duration of use. Product users projected a better first impression and appeared on average 3 years younger than their actual age, with 86% of subjects reporting increased confidence. Product users found random people of the opposite sex to be more attractive 88% of the time and reported improvement in sexual satisfaction in 90% of the categories. CONCLUSIONS: The use of this novel topical product culminated in statistically significant improvements in skin quality, confidence, sexual relationship satisfaction, perceived attractiveness, and youthfulness, highlighting its potential in anti-aging and mood enhancement.

A Review of Neuromodulators and Energy-Based Devices for Optimizing Nasal Appearance.

Importance: The demand for less invasive nasal procedures has been increasing, highlighting a gap in research on alternatives beyond fillers. This review explores the potential of neuromodulators and energy-based devices for nonsurgical rhinoplasty. Observations: Both botulinum toxin and energy-based devices used independently or alongside fillers have been studied for nasal shape adjustments. Neuromodulator injection of the depressor septi nasi can reduce nasal tip droop, which can reduce the appearance of a plunged nose. Treatment of the dilator naris can minimize alar flaring, giving the appearance of a thinner nasal tip. These methods primarily reported patient-reported outcomes. Energy-based devices have been used to address nasal skin quality and shape contouring, including resurfacing devices for rhinophyma with improvement in both physician and patient-reported outcomes. The 1470 nm laser achieved nasal reshaping after two sessions. Radiofrequency microneedling was notable for volumetric reduction in the nose (excluding nasal tip), confirmed by 3D imaging, lasting about 12 months. Conclusions and Relevance: The use of neuromodulators and energy-based devices may offer promising results for nasal reshaping. However, there is a need for further comparison studies using both objective measures such as 3D photography and physician and patient-reported outcomes, prior to establishing best practices for these techniques.

Optimal Practices in the Delivery of Aesthetic Medical Care to Patients on Immunosuppressants and Immunomodulators: A Systematic Review of the Literature.

Non-surgical aesthetic procedures have been steadily growing in popularity among patients of all ages and ethnicities. At present, the literature remains devoid of guidelines on optimal practices in the delivery of aesthetic medical care to patients on immunosuppressant medications. The authors of this review seek to determine the physiologic responses of immunocompromised patients, with regards to outcomes and potential complications, following non-surgical aesthetic procedures and to suggest recommendations for optimal management of these patients. A comprehensive systematic review of the literature was performed to identify clinical studies of patients who had undergone non-surgical aesthetic procedures while immunosuppressed. 43 articles reporting on 1690 immunosuppressed patients who underwent filler injection were evaluated, of which the majority (99%; 1682/1690) were HIV patients while the remaining eight were medically immunosuppressed. The complication rate of filler in this population was of 28% (481/1690), with subcutaneous nodules consisting of the most frequently reported adverse event. A detailed synthesis of complications and a review of the inflammatory responses and impact of immunosuppressants and HIV infection on filler complications is presented. The authors concluded that patients on immunomodulatory medications may be at increased risk of filler granuloma relative to the general population, while patients on immunosuppressants may be at increased risk of infectious complications. Rudimentary guideines for optimal pre-proceural patient assessment, aseptic technique, injection technique and finally anti-bacterial and anti-viral prophylaxis are reviewed. Ongoing advancements in our understanding of the mechanisms underlying these inflammatory processes will undoubtedly optimize management in this patient population.

Energy-Based Devices for the Treatment of Facial Skin Conditions in Skin of Color.

Background: The development of microfocused ultrasound and fractional radiofrequency-based devices has expanded the range of cosmetic treatment options for patients with skin of color. Fractional non-ablative laser treatments can also be safely performed in skin types III-VI with appropriate settings and adjunctive topical treatments. Objective: We sought to review the available literature on the use of energy-based devices for treatment of facial skin conditions in skin types III-VI. Methods: A PubMed search was performed on studies from 2010-2021 assessing safety and efficacy of fractional ablative and non-ablative lasers, radiofrequency, and microfocused ultrasound-based treatments for conditions such as acne scars, melasma, benign pigmented lesions, rhytids, and skin laxity in skin types III-VI. Results: Seven randomized trials, fourteen prospective cohort studies, and six retrospective reviews were included. Combination treatment with fractional radiofrequency and non-ablative laser has demonstrated efficacy in the treatment of acne scars in skin of color with minimal adverse effects. Laser-assisted drug delivery with low-density 1927-nm thulium or diode lasers has been shown to reduce the number of treatments required for significant clearance of melasma as compared with other modalities. Microfocused ultrasound has been shown to safely treat skin laxity in skin of color. Limitations: There is a paucity of studies which include patients with skin type VI, limiting our overall understanding of the safety of these treatments in skin of color. Conclusion: There are numerous available studies demonstrating safety and efficacy of energy-based devices for the treatment of facial skin conditions in skin types III-VI, but the significant variation among their designs, methods of assessment, and study populations highlights the need for larger meta-analyses to further interpret their results.

A Review of Aesthetic Considerations for Treating the Transgender Patient.

BACKGROUND: As gender diversity becomes increasingly embraced by society, and despite growing recognition of the unique needs of transgender patients, the literature remains devoid of guidelines for gender affirming facial feminization or masculinization techniques. OBJECTIVE: The authors seek to identify and discuss target feminine and masculine facial features, as well as an armamentarium of surgical and nonsurgical strategies to effectively address and achieve them in the transgender population. METHODS: A search of the National Library of Medicine database (PubMed) was undertaken to identify the existing literature on gender-affirming facial feminization and masculinization techniques. RESULTS: The importance of assessing proportional relationships between the bitemporal, bizygomatic, and bigonial distances is discussed; ideal masculine faces possess a rectangular face shape, with ratios for these 3 areas tending toward 1:1:1. Conversely, the ideal female face is heart shaped with projection at the zygoma and a tapered jawline. Strategic positioning of the cheek apex serves as an anchor in sculpting a distinctly masculine or feminine face. Other considerations include the enhancement of skin quality and implications of hormonal therapy. CONCLUSION: The aesthetic considerations provided in this study can serve as a valuable guidance for aesthetic physicians seeking to deliver optimal care for their transitioning patients.

Extension Phase of a Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial.  Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks. RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort.  Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270.     doi:10.36849/JDD.7622.

Aesthetic considerations when treating patients of African descent: Thriving in diversity international roundtable series.

BACKGROUND: Black patients of African descent are an ethnically diverse demographic and have unique anatomical features, aging processes, and responses to aesthetic procedures that must be considered when planning treatment. AIMS: To discuss similarities and differences in the anatomy and treatment preferences of Black patients of African descent and explore how these differences may influence aesthetic practices. PATIENTS/METHODS: In support of clinicians who wish to serve a diverse patient population, a 6-part international roundtable series focused on diversity in aesthetics was conducted from August 24, 2021, to May 16, 2022. RESULTS: The results of the third roundtable in the series, the African Patient, are described here. The expertise and perspectives of African physicians, US physicians who treat African American patients, and physicians practicing within Latin America and Europe who treat patients of color (POC) of African descent are included, as well as information gleaned from injection demonstrations. CONCLUSIONS: Black African patients seek aesthetic treatment for a variety of conditions. Patients with darker skin can benefit from treatment with fillers, neurotoxins, and energy-based devices, but the application of these approaches should take into account the unique characteristics of each individual patient and the cultural and biological influences that impact treatment outcomes.

Esthetic considerations for treating the patient of European descent: Thriving in diversity international roundtable series.

BACKGROUND: The European esthetic experience is informative for understanding both innovation as well as how to care for patients of various backgrounds and ages. AIMS: To discuss best practices for treating the European population and how these approaches may be applied to patient populations across the globe. PATIENTS/METHODS: In support of clinicians who wish to serve a diverse patient population, a 6-part, international roundtable series focused on diversity in esthetics was conducted from August 24, 2021 to May 16, 2022. In each roundtable, expert clinicians were invited to contribute and share best practices. RESULTS: The results of the fifth roundtable in the series, the European Patient, are described here. Key ideas include the growing number of people over the age of 65 years in Europe and the management of this more mature patient population; the role of functional anatomy in treating patients with both fillers and botulinum toxin; and the role of ultrasound in clinical practice for mapping vasculature. CONCLUSIONS: While there is no typical European face, there is much to be learned from thoughtful consideration of how to best manage more mature patients as well as how to use minimally invasive modalities, such as injectables, efficiently to achieve natural-looking results.

Collagenase Clostridium Histolyticum-aaes Injections for Volumetric Change of Cellulite Dimples and Gluteal Contouring.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH) is approved for the treatment of moderate-to-severe cellulite. OBJECTIVE: This is a retrospective image review of subjects previously enrolled in Cohort 2 of the EN3835-305 trial to determine the effects of CCH on volumetric changes of cellulite dimples and overall gluteal contouring. METHODS: In this retrospective analysis, photographs from Day 90 and Day 180 were superimposed on baseline images and the volumetric change of each treated cellulite dimple was quantified. Side-by-side photographs of the buttocks were also evaluated for change in gluteal contour using the Physician Global Aesthetic Improvement Scale (PGAIS). RESULTS: Fifty-eight female subjects and 403 cellulite dimples were evaluated. Three-dimensional imaging analysis revealed a significant improvement in total negative dimple volume at both Day 90 and Day 180 of 27% and 26%, respectively ( p < .001 and p = .002, respectively). At Day 90, the overall gluteal contour, as signified by the mean PGAIS among the 3 blinded dermatologists, was rated as +1 (improved) in 27% ( n = 17) of the subjects. At Day 180, the mean PGAIS was +1 (improved) or +2 (very much improved) in 39% ( n = 26) of the subjects. CONCLUSION: CHH is an effective tool for treating cellulite dimples and improving gluteal contour.

A Randomized, Single-Center, Double-Blinded, Split-Body Clinical Trial of Poly- l -Lactic Acid for the Treatment of Cellulite of the Buttocks and Thighs.

BACKGROUND: More than 90% of women report concerns of cellulite on their skin. Poly- l lactic acid (PLLA-SCA) is a biocompatible, semipermanent, synthetic filler that induces neocollagenesis. OBJECTIVE: To investigate the safety and efficacy of PLLA-SCA for the treatment of cellulite of the buttock and thigh regions. METHODS: This was a prospective, single-center, double-blinded, split-body, clinical trial of 20 women with slight to moderate skin laxity of the buttocks and/or thighs contributing to mild-to-moderate cellulite. Each subject's buttocks and thighs were randomized to receive injections with up to 2 vials of PLLA-SCA or the equivalent volume of bacteriostatic water per treatment area. Subjects received at total of 3 treatments 4 weeks apart and were followed for 330 days. RESULTS: Treatment of the buttocks with PLLA-SCA resulted in significant reduction of depression depth, improvement in the morphological appearance of the skin, improvement in the grade of skin laxity, and overall improvement in cellulite appearance. Treated thighs showed reduction in the depth and number of depressions and an improvement in overall cellulite appearance. No significant procedure side effects were found. CONCLUSION: Poly- l lactic acid offers an effective and safe method for treating cellulite of the buttocks and thighs.

Making Sense of Late Tissue Nodules Associated With Hyaluronic Acid Injections.

BACKGROUND: The pathogenesis of delayed-onset tissue nodules (DTNs) due to hyaluronic acid (HA) injections is uncertain. OBJECTIVES: To formulate a rational theory for DTN development and their avoidance and treatment. METHODS: A multidisciplinary and multicountry DTN consensus panel was established, with 20 questions posed and consensus sought. Consensus was set at 75% agreement. RESULTS: Consensus was reached in 16 of 20 questions regarding the pathogenesis of DTNs, forming the basis for a classification and treatment guide. CONCLUSIONS: The group believes that filler, pathogens, and inflammation are all involved in DTNs and that DTNs most likely are infection initiated with a variable immune response. Injected filler may incorporate surface bacteria, either a commensal or a true pathogen, if the skin barrier is altered. The initially high molecular weight HA filler is degraded to low molecular weight HA (LMWHA) at the edge of the filler. Commensals positioned within the filler bolus may be well tolerated until the filler is degraded and the commensal becomes visible to the immune system. LMWHA is particularly inflammatory in the presence of any local bacteria. Commensals may still be tolerated unless the immune system is generally heightened by viremia or vaccination. Systemic pathogenic bacteremia may also interact with the filler peripheral LMWHA, activating Toll-like receptors that induce DTN formation. Given this scenario, attention to practitioner and patient hygiene and early systemic infection treatment deserve attention. Classification and treatment systems were devised by considering each of the 3 factors-filler, inflammation, and infection-separately.

Efficacy and Safety of Intense Pulsed Light and Nonablative Fractional 1440-nm Diode Laser to a Combination of the 2 Modalities for Facial Rejuvenation.

BACKGROUND: The aging process involves laxity, hyperpigmentation, and telangiectasias. It is important to target those elements of aging to be successful at achieving rejuvenation. OBJECTIVE: To determine the efficacy, safety, and patient satisfaction of a combination intense pulsed light (IPL) and 1440-nm diode laser versus either treatment alone. METHODS: Forty subjects were enrolled in this randomized split-face trial: 20 were randomized to Group A (received IPL on one side of the face and IPL followed by the 1440-nm diode laser on the other side) and 20 were randomized to Group B (received 1440-nm diode laser on one side of the face and IPL followed by the 1440-nm diode laser on the other side). RESULTS: Investigators reported a percent improvement of 40% to 50% in all 3 groups at day 120; blinded investigator Global Aesthetic Improvement Scores were better in the combination group-90% compared with 84% and 83% in the IPL and 1440-nm diode laser groups, respectively. Wrinkling scores was significantly improved in the 1440-nm diode and combination groups. Hyperpigmentation and telangiectasias were significantly improved in all 3 groups. Adverse events were self-limited. CONCLUSION: Combination treatment with IPL and 1440-nm diode laser was found to be safe and effective and resulted in higher subject satisfaction.

Real-world effectiveness and safety of collagenase clostridium histolyticum-aaes injections for the treatment of thigh cellulite in women: An open-label study interim analysis.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women. AIM: Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite. METHODS: Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas. RESULTS: Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively). CONCLUSIONS: CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.

The Efficacy and Safety of Radiofrequency Microneedling Versus a Nonablative Fractional 1,550-nm Erbium:Glass Laser for the Rejuvenation of the Neck.

BACKGROUND: Radiofrequency microneedling (RFMN) and nonablative fractional 1,550-nm erbium:glass lasers (NAFLs) have been reported to be used with success in neck rejuvenation. There are no head-to-head trials to compare these modalities. OBJECTIVE: The purpose of the study was to compare the efficacy and safety of radiofrequency microneedling and nonablative fractional 1,550-nm erbium:glass lasers for the rejuvenation of the neck. METHODS: This was a single-center, randomized, investigator-blinded clinical trial. A total of 21 subjects were randomized into 2 groups, NAFL and RFMN; subjects received 3 treatments 4 weeks apart and were followed up 12 weeks after last treatment. RESULTS: Subjects in NAFL and RFMN groups showed 42.1% and 8.6% improvement in the Fitzpatrick-Goldman Wrinkling Score, respectively, 41.3% and 16.3% improvement in the elastosis score, respectively. Subjects in the NAFL 1,550-nm erbium:glass group showed significantly better blinded investigator Fitzpatrick-Goldman Wrinkling and Elastosis scores; subjects in the RFMN groups showed a more significant reduction in the Horizontal Neck Wrinkle Severity Score. There was a trend for higher patient satisfaction with the NAFL. CONCLUSION: This study showed that both treatments resulted in significant improvement in wrinkling and elastosis scores; the NAFL treatment was associated with significantly better blinded investigator Fitzpatrick-Goldman Wrinkling and Elastosis scores and better subject satisfaction.

Is the Technology Era Aging You? A Review of the Physiologic and Psychologic Toll of Technology Use.

BACKGROUND: Technology use is at an all-time high and its potential impact on psychological and physiologic health should be explored. OBJECTIVE: The objective of this narrative review was to identify the role of technology use on health and well-being. MATERIALS AND METHODS: Authors performed a review of PubMed and publications of the World Health Organization, Department of Defense, and Centers for Disease Control and Prevention to determine the impact of technology regarding electromagnetic radiation (EM), posture and mobility, sleep disturbance, and psychological stress and well-being. RESULTS: Studies on the impact of EM were conflicting, with about 45% reporting negative consequences and 55% reporting no effect. Radiofrequency EM (RF-EM) may more significantly affect fibroblasts and immature cells. Device use was implicated in worsening cognitive focus, imbalance, and sleep. Social media use affects self-esteem and mental health and is associated with up to 33% presence of addiction. Effects seem to be dose related and more pronounced in younger ages. CONCLUSION: Technology use significantly affects sleep, mental health, and cognitive function. Seeking psychological help, limiting social media use, and reducing use before sleep may partially mitigate these effects. The impact of EM is undetermined, but the WHO lists RF-EM as a potential carcinogen.

Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.

Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.

Cutaneous Vascular Compromise and Resolution of Skin Barrier Breakdown After Dermal Filler Occlusion-Implementation of Evidence-Based Recommendations Into Real-World Clinical Practice.

BACKGROUND: Vascular occlusions that threaten skin integrity, although not an emergency like those that threaten a patient's vision, is an urgent situation. Accurately interpreting physical examination findings is paramount. The use of high-dose, pulsed hyaluronidase is the mainstay of therapy; however, adjunctive measures that may optimize clearance of an occlusion and/or skin barrier repair such as the use of image guidance and hyperbaric oxygen should be considered. OBJECTIVE: To provide a review of the literature on the treatment of vascular occlusions threatening skin barrier integrity and develop a step-wise treatment guide. MATERIALS AND METHODS: The authors searched PubMed for peer-reviewed studies, consensus statements, case series, and case reports using a variety of keywords. RESULTS: Twenty-six articles focusing on vascular occlusions threatening the skin barrier were reviewed. The authors collectively agreed on treatments to reverse vascular occlusions and restore the skin barrier. The importance of high-dose, pulsed hyaluronidase was clear. Therapies that lacked evidence such as sodium thiosulfate were also revealed. CONCLUSION: A vascular occlusion that threatens skin integrity is an urgent matter which requires accurate interpretation of physical examination findings that will help guide intervention. High-dose, pulsed hyaluronidase along with adjunctive measures performed in a step-wise manner is key to an optimal outcome.

Validated 5 - Point photonumeric scales for the assessment of hand atrophy.

OBJECTIVE: Quantifying the degree of dorsal hand atrophy is a challenging endeavor, but often necessary, in both the clinical and the research setting. The aim of this investigation was to create and consecutively validate a 5-point photonumeric scale for assessment of dorsal hand atrophy. MATERIAL AND METHODS: A medical team created a novel 5-point photonumeric scale. Twelve international raters were involved in the digital validation, while five raters performed a live validation. RESULTS: For the digital validation of the Croma Hand Atrophy Assessment Scale, a total of 72 subjects (58 females, 14 males) with a mean age of 43.0 ± 14.4 years [18-73 years] were assessed. For the live validation, 88 subjects (73 females, 15 males) with a mean age of 45.0 ± 14.1 years [20-73 years] were rated. The results revealed almost perfect intra-rater (ICC: 0.90 [95% CI: 0.88-0.92]) and inter-rater agreements (ICC: 0.85 [95% CI: 0.81-0.89] and 0.86 [95% CI:0.82-0.89]) in the digital validation and substantial intra-rater (ICC: 0.79 [95% CI: 0.75-0.82]) and inter-rater agreements (ICC: 0.75 [95% CI: 0.68-0.81] and ICC: 0.67 [95% CI: 0.54-0.77]) in the live validation. CONCLUSION: The created scale to assess dorsal hand atrophy has been shown to provide substantial-to-almost perfect agreement in the digital and live validation cycles and reached comparable intra-rater and inter-rater agreement to already published and validated scales. It is expected that the created scale will help physicians and researchers in the assessment of hand atrophy in the clinical and research setting in the future.

Study of a New Controlled Focal Septa Release Cellulite Reduction Method.

BACKGROUND: Cellulite is the dimpled appearance of skin that commonly occurs on the buttocks and thighs of postpubertal women. Cellulite can be emotionally distressing, causing many individuals to seek medical attention. A previous first-in-human study established the safety and feasibility of a novel minimally invasive method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner. OBJECTIVES: The objective of this open-label, multicenter study was to evaluate the safety, efficacy, and feasibility of this method for reducing the appearance of moderate and severe cellulite in adult women. METHODS: Female patients (n = 20) 21 to 55 years old with a BMI ≤ 35 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were enrolled at 4 clinics. Patients were evaluated on posttreatment Days 7, 30, 120, and 180. The primary endpoint was a mean ≥1-point reduction in the Cellulite Severity Scale at 180 days. RESULTS: Most patients (n = 18, 95%) achieved the primary endpoint. All patients (n = 19, 100%) were rated as much improved or very much improved in Cellulite Severity Scale scores. Adverse events and investigator findings were mild and transient, and none were unexpected. CONCLUSIONS: A novel method for selectively identifying and manually releasing the specific septa responsible for causing cellulite depressions in a precise manner is a safe and effective means for improving the appearance of moderate and severe cellulite in adult women with a wide variety of skin types.

Validated 5-point photonumeric scales for the assessment of the periorbital region.

OBJECTIVE: The objective of this investigation was to create and validate 5-point photonumeric scales for the assessment of dynamic crow's feet, static crow's feet, and infraorbital hollows. MATERIAL AND METHODS: Three novel 5-point photonumeric scales were created by a medical team. A total of 12 raters from all over the world performed a digital validation, and a total of 5 raters a live validation of the created scale. RESULTS: The statistical analysis revealed almost perfect intra-rater and inter-rater reliability in the digital validation of the scales for the assessment of static and dynamic crow's feet as well as infraorbital hollows. In the live validation, both crow's feet scales showed almost perfect intra-rater reliability, while the Croma Infraorbital Hollow Assessment Scale showed substantial intra-rater reliability. Inter-rater reliability was substantial for all three scales in the live validation. All three scales, the Croma Dynamic Crow's Feet Assessment Scale, Croma Static Crow's Feet Assessment Scale, and Croma Infraorbital Hollow Assessment Scale, were validated digitally and in a live setting. CONCLUSION: The created scales to assess infraorbital hollowing, dynamic and static crow's feet have been shown to provide substantial to almost perfect agreement in the digital and live validation and can thus be considered as helpful tools in the clinical and research setting. While technical methods and appliances to assess the degrees of severity of age-dependent features are advancing, validated scales are of great importance due to their ease of use and, as shown by the validations, reliability, and reproducibility.