High-Intensity, High-Frequency, Parallel Ultrasound Beams for Cellulite of the Buttocks and Thighs.

BACKGROUND: Ultrasound energy can successfully treat fine lines and wrinkles, as well as lift the eyebrow and submentum. Ultrasound waves of high intensity induce thermal injury in the dermis with subsequent tissue remodeling. OBJECTIVE: To examine the utility of a novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams to improve the clinical appearance of cellulite on the thighs and buttocks. MATERIALS AND METHODS: A prospective, multicenter, clinical study investigated this novel ultrasound device using 2 treatments. RESULTS: Sixty-five subjects completed both treatments. The mean age was 46 years, and 100% were women. Fitzpatrick skin types I to VI were represented. Assessments compared 3-month follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 89.2%. For Cellulite Severity Scale rating, there was significant improvement of 1.61 units (p < .001). For cellulite Global Aesthetic Improvement Scale (GAIS), 89.2% had improvement, with a mean of 0.87 units (p < .001). For Laxity Scale rating, there was significant improvement of 0.70 units (p < .001). For skin laxity GAIS, 89.2% had improvement, with a mean of 0.76 units (p < .001). No device-related adverse events occurred. CONCLUSION: A novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams can safely and effectively improve the clinical appearance of cellulite on the thighs and buttocks.

Pilot Study to Demonstrate Improvement in Skin Tone and Texture by Treatment with a 1064 nm Q-Switched Neodymium-Doped Yttrium Aluminum Garnet Laser.

BACKGROUND: The 1064 nm Q-switched neodymium-doped yttrium aluminum garnet (QS Nd:YAG) laser was developed to treat unwanted pigmentation in the skin such as lentigines caused by photoaging, and tattoos from dye/ink insertion. This laser has also been used for non-ablative epidermal rejuvenation (skin toning). OBJECTIVE: To evaluate changes in skin tone, skin texture and overall improvement after a series of treatments with the QS Nd:YAG laser. METHODS: Participants received seven full-face treatments with M22 or Stellar M22, a 1064 nm QS Nd:YAG laser, at 2-week intervals. The investigators and participants evaluated the improvement in skin tone and texture at 1, 3 and 6 months after the last treatment. Patient satisfaction, patient discomfort, downtime and adverse events were recorded. Histological changes in the treated area were also evaluated. RESULTS: Thirteen women with a median age of 45 years (range, 34-61 years) were included in the study. The majority of the participants (53.9%) had skin type VI. One month after the last treatment session, 38% of participants reported good to very good improvement. This value increased to 100% participant improvement at both the 3-month and 6-month follow-up visits. The reduction in melanin index and the histological analysis demonstrated that the laser procedure contributed to a reduction in epidermal melanin content. Treatments were not associated with high levels of pain or discomfort. The most common immediate post-treatment response was erythema and edema. Most participants were satisfied with the resulting treatment outcome. CONCLUSION: Skin treatment with the 1064 nm QS Nd:YAG laser module on the M22 and Stellar M22 devices, using a large spot size, low fluence, moderately high repetition rate, improves skin tone and texture in patients with skin types II-VI.

Developing relationships with patients, staff, and industry in dermatology.

Maintaining a thriving dermatology practice requires thoughtful and intentional investment in relationships with patients, staff, and industry. Growing the patient-physician relationship involves optimizing patient satisfaction and outcomes, which can provide improved ratings and reimbursement. Cultivating an environment of employee engagement is also essential for promotion of patient satisfaction, employee satisfaction, and practice productivity. Additionally, relationships with industry require careful navigation to maximize its great potential for medical advancement and benefit for all parties. There are inherent conflicts of interest between physician motivation for improved patient outcomes and industry goals of increased profits. Successful management of these relationships can be a difficult task, but it remains important.

Improved Patient Satisfaction With Skin After Treatment of Cheek Skin Roughness and Fine Lines With VYC-12L: Participant-Reported Outcomes From a Prospective, Randomized Study.

BACKGROUND: VYC-12L is a hyaluronic acid filler to improve skin quality. A prospective study showed safety and effectiveness of VYC-12L for improving cheek skin smoothness and fine lines. OBJECTIVES: To report participant-reported outcomes, subgroup analyses, and physician experience from the prospective study. METHODS: Adults with moderate to severe Allergan Cheek Skin Smoothness (ACSS) scale scores were randomized 2:1 to VYC-12L or control (no treatment with optional treatment). Participant assessments included FACE-Q Satisfaction With Skin, FACE-Q Appraisal of Lines, natural look and feel, the Global Aesthetic Improvement Scale (GAIS), and safety. Subgroup analyses examined ACSS responder rate (≥1-grade improvement from baseline to 1 month). RESULTS: FACE-Q Satisfaction With Skin overall mean scores improved from baseline to 1 month posttreatment by 32.0 and 1.4 in the VYC-12L and control groups, respectively. FACE-Q Appraisal of Lines overall mean scores improved from baseline to 1 month posttreatment by 23.3 and 0.4 in VYC-12L and control, respectively. Treated participants had high median scores (≥9.0) of natural look and feel of their cheek skin. GAIS responder rate was high at Month 1 (85.5%; 95% CI, 79.3%-91.7%) and through Month 6 (83.1%; 95% CI, 76.5%-89.7%). Mean participant-rated pain scores were low (<3). The most common injection site reactions were redness, swelling, and lumps/bumps; most resolved within 3 days. Subgroup analyses showed significant differences in ACSS responder rate between VYC-12L and control groups 1 month posttreatment. Physician injectors reported that VYC-12L was easily injected at the superficial skin and integrated quickly. CONCLUSIONS: VYC-12L treatment produced significant improvements in satisfaction with skin and cheek skin smoothness, as measured by participant-reported outcome measures.

Exosomes: the latest in regenerative aesthetics.

Regenerative aesthetics is a burgeoning field for skin rejuvenation and skin health restoration. Exosomes, or extracellular vesicles, represent a new and minimally invasive addition to the regenerative aesthetic toolbox. These nano-sized vesicles contain bioactive cargo with crucial roles in intercellular communication. Exosome technology, while still in its infancy, is now leveraged in regenerative aesthetic medicine due to its multifaceted role in targeting root causes of skin aging and improving overall tissue homeostasis. The main considerations for practice utilization include variation in exosome purification, isolation, storage, scalability and reproducibility. This review aims at highlighting the current and emerging landscape of exosomes in aesthetic medicine including skin rejuvenation and hair restoration.

What is this article about? The purpose of this paper is to review available studies that look at the effects of exosomes in aesthetic medicine and cosmetic surgery. A thorough literature search of all available studies was performed. What were the results? Topical exosomes, although variable in source and method of isolation, are generally considered safe in humans on intact skin. The current published research literature does not yet provide a clear consensus on long-term use for skin rejuvenation or hair restoration, nor does it delineate which patients would benefit most from this technology. There are no currently US FDA-approved exosome products on the market for medical indications. What do the results of this literature review mean? More clinical studies with proper regulatory oversight are needed.

Real-time, in vivo skin cancer triage by laser-induced plasma spectroscopy combined with a deep learning-based diagnostic algorithm.

BACKGROUND: Although various skin cancer detection devices have been proposed, most of them are not used owing to their insufficient diagnostic accuracies. Laser-induced plasma spectroscopy (LIPS) can noninvasively extract biochemical information of skin lesions using an ultrashort pulsed laser. OBJECTIVE: To investigate the diagnostic accuracy and safety of real-time noninvasive in vivo skin cancer diagnostics utilizing nondiscrete molecular LIPS combined with a deep neural network (DNN)-based diagnostic algorithm. METHODS: In vivo LIPS spectra were acquired from 296 skin cancers (186 basal cell carcinomas, 96 squamous cell carcinomas, and 14 melanomas) and 316 benign lesions in a multisite clinical study. The diagnostic performance was validated using 10-fold cross-validations. RESULTS: The sensitivity and specificity for differentiating skin cancers from benign lesions using LIPS and the DNN-based algorithm were 94.6% (95% CI: 92.0%-97.2%) and 88.9% (95% CI: 85.5%-92.4%), respectively. No adverse events, including macroscopic or microscopic visible marks or pigmentation due to laser irradiation, were observed. LIMITATIONS: The diagnostic performance was evaluated using a limited data set. More extensive clinical studies are needed to validate these results. CONCLUSIONS: This LIPS system with a DNN-based diagnostic algorithm is a promising tool to distinguish skin cancers from benign lesions with high diagnostic accuracy in real clinical settings.

Safety, Efficacy, and Tolerability of Simultaneous Bilateral Cryolipolysis Using a Rapid Cycling Contoured Cup Applicator for Noninvasive Fat Reduction in the Enlarged Male Breast: A Pilot Study.

BACKGROUND: A previous study using a parallel cooling plate cryolipolysis applicator demonstrated the efficacy of cryolipolysis for pseudogynecomastia. Although the procedure was safe and effective, treatment times were prolonged and anesthetic was needed to reduce treatment discomfort. OBJECTIVE: To evaluate the safety, efficacy, and tolerability of a short cycle, reduced vacuum contoured cup cryolipolysis applicator for the treatment of pseudogynecomastia. MATERIALS AND METHODS: Twelve male subjects received simultaneous bilateral treatment consisting of a 35-minute cryolipolysis cycle, followed by a short manual massage, and a second 35-minute cycle with 50% treatment area overlap in a single treatment visit. At the 6-week follow-up, a second treatment was performed with up to 2 overlapping cycles per side. Efficacy was assessed after the second treatment using transcutaneous ultrasound, standardized clinical photography, and subject surveys. RESULTS: Ultrasound analysis showed a mean fat layer reduction of 5.1 ± 2.3 mm (p < .001). Blinded, independent reviewers correctly identified 97% of baseline/treatment photography results. Surveys revealed 100% subject satisfaction with 91% reporting visible fat reduction and 100% stating they would recommend treatment. Transient side effects included mild intratreatment discomfort, paresthesia, and tenderness. CONCLUSION: A rapid cycling, reduced vacuum cryolipolysis applicator provides rapid, safe, effective, and tolerable treatment of pseudogynecomastia.

Subject satisfaction and psychological well-being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines.

BACKGROUND: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). AIMS: Evaluation of subject-reported indicators of treatment efficacy, satisfaction, and psychological well-being with ABO dose escalation. METHODS: A Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject-assessed improvement in line severity of ≥1-grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE-Q™ appraisal of lines, psychological well-being and age, and subject satisfaction. RESULTS: The study included 399 subjects (88.2% were female). Respective responder rates (≥1-grade improvement) with ABO 50-125 U doses ranged between 96.3%-100% at Week 4, 65.0%-67.9% at Week 24, and 33.8%-44.4% at Week 36. GAIS responder rate and FACE-Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well-being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. CONCLUSIONS: A single ABO treatment (dosed at 50-125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well-being.

Submental Area Treatment with ATX-101: Relationship of Mechanism of Action, Tissue Response, and Efficacy.

ATX-101 is an injectable, synthetically derived formulation of deoxycholic acid used for submental fat reduction. Methods: A narrative review of references relevant to the mechanism of action of ATX-101 and its relationship to efficacy and inflammatory adverse events was conducted. Results: When injected into subcutaneous fat, deoxycholic acid physically disrupts adipocyte cell membranes, leading to local adipocytolysis, cell death, and a mild, local inflammatory reaction consisting of macrophage infiltration and fibroblast recruitment. At Day 28 postinjection, inflammation largely resolves, and key histologic features include fibrotic septal thickening, neovascularization, and atrophy of fat lobules. Based on the mechanism of action of ATX-101 and the demonstrated inflammatory response, localized inflammation and swelling are expected following treatment. Indeed, postinjection swelling and other local injection-site events, including pain, erythema, and bruising, are common during and after treatment. Because of inflammatory sequelae following injection, reduction in submental fat is gradual and may require months before the full response is apparent. Patients may also require multiple treatment sessions to achieve their treatment goals. Repeated treatments may result in less pain and swelling over time owing to a combination of factors, including less target tissue allowing for lower doses/injection volumes, persistent numbness, and greater tissue integrity from thickened fibrous septa. Conclusions: Physicians can manage expectations by counseling patients that, based on the mechanism of action of ATX-101 and data from pivotal clinical trials, ATX-101 treatment results in localized inflammation/swelling and gradual submental fat reduction. Patient education about common local adverse events is critical.

"COVID-19/SARS-CoV-2 virus spike protein-related delayed inflammatory reaction to hyaluronic acid dermal fillers: a challenging clinical conundrum in diagnosis and treatment".

We present the first reported cases of delayed inflammatory reactions (DIR) to hyaluronic acid (HA) dermal fillers after exposure to the COVID-19 spike protein. DIR to HA is reported to occur in the different scenarios including: secondary to poor injection technique, following dental cleaning procedures, following bacterial/viral illness, and after vaccination. In this report of 4 cases with distinct clinical histories and presentations: one case occured following a community acquired COVID-19 infection, one case occured in a study subject in the mRNA-1273 clinical phase III trial, one case occurred following the first dose of publically available mRNA-1273 vaccine (Moderna, Cambridge MA), and the last case occurred after the second dose of BNT162b2 vaccine (Pfizer, New York, NY). Injectable HA dermal fillers are prevalent in aesthetic medicine for facial rejuvenation. Structural modifications in the crosslinking of HA fillers have enhanced the products' resistance to enzymatic breakdown and thus increased injected product longevity, however, have also led to a rise in DIR. Previous, DIR to HA dermal fillers can present clinically as edema with symptomatic and inflammatory erythematous papules and nodules. The mechanism of action for the delayed reaction to HA fillers is unknown and is likely to be multifactorial in nature. A potential mechanism of DIR to HA fillers in COVID-19 related cases is binding and blockade of angiotensin 2 converting enzyme receptors (ACE2), which are targeted by the SARS-CoV-2 virus spike protein to gain entry into the cell. Spike protein interaction with dermal ACE2 receptors favors a pro-inflammatory, loco-regional TH1 cascade, promoting a CD8+T cell mediated reaction to incipient granulomas, which previously formed around residual HA particles. Management to suppress the inflammatory response in the native COVID-19 case required high-dose corticosteroids (CS) to suppress inflammatory pathways, with concurrent ACE2 upregulation, along with high-dose intralesional hyaluronidase to dissolve the inciting HA filler. With regards to the two vaccine related cases; in the mRNA-1273 case, a low dose angiotensin converting enzyme inhibitor (ACE-I) was utilized for treatment, to reduce pro-inflammatory Angiotensin II. Whereas, in the BNT162b2 case the filler reaction was suppressed with oral corticosteroids. Regarding final disposition of the cases; the vaccine-related cases returned to baseline appearance within 3 days, whereas the native COVID-19 case continued to have migratory, evanescent, periorbital edema for weeks which ultimately subsided.

Trends in cosmetic consumer preferences during COVID-19 pandemic: Comparing 2021 to 2020.

This commentary evaluates trends in the factors influencing consumer decision-making for cosmetic dermatologic procedures during the COVID-19 pandemic in the United States. This is a follow-up national survey to one that was published 1 year ago. This study compares the data from Summer 2020 to early Summer 2021, which presents a stark contrast. Our results demonstrate that consumers are now more interested in cosmetic dermatologic procedures compared to 1 year prior. Additionally, they still value the overall safety of the clinic, so physicians should ensure that certain safety measures remain in place despite any decreasing rates of COVID-19 positivity. Our survey sheds more light on current consumer perspectives, which may in turn help physicians adjust their practices to meet current demand. It is important for physicians to be knowledgeable regarding the patterns of consumer decision-making in order to deliver appropriate patient education and provide proper patient outreach during the COVID-19 pandemic.

Optimizing skin tightening in aesthetics in men.

The field of cosmetic dermatology has recently witnessed unbridled growth in the past several years. Part of this has been due to the increasing popularity of aesthetic treatments in men, who represent a growing patient population. Men tend to have higher levels of collagen density and greater skin thickness, but these begin to decrease earlier on. They can also more frequently have severe photodamage. Their clinical presentations can affect the selection of treatments. Physicians should be familiar with the subtle differences between treating men and women. Early studies and literature are beginning to shed more light on these important distinctions. We review the notable differences in facial aging, pathophysiology, and patient selection and discuss available treatment options with these factors in mind.

AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study.

OBJECTIVE: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines. DESIGN: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. METHODS: Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving a severity score of 0 (none) or 1 (mild) at maximum frown, evaluated using concurrent investigator and subject assessments. Secondary endpoints included ≥1-grade severity improvement, duration of effect, and reporting of treatment-emergent adverse events (TEAEs). RESULTS: Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen. CONCLUSION: A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263.

A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea.

BACKGROUND AND OBJECTIVES: We evaluated if oxymetazoline therapy combined with 595-nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of erythematotelangiectatic rosacea. STUDY DESIGN/MATERIALS AND METHODS: This was a randomized, controlled, prospective clinical trial approved by an independent Institutional Review Board, which enrolled 34 patients with moderate to severe clinical erythema (CEA) into a two-arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients in Arm 1 were treated with 3 monthly laser sessions, which were started after 1 month of topical oxymetazoline cream. Thirty subjects continued with the study, and 25 subjects (Arm 1: 14, Arm 2: 11) completed the 6-month follow-up. With photographic comparison to baseline images, efficacy endpoints were based on clinical on-site grading by both the investigator and the patient, using the grading tools for CEA, Global Aesthetic Improvement (GAI) assessment, vessel size improvement, and subject self-assessment. These scales were assessed at baseline and/or at each clinical follow-up at 1, 2, 3, and 6 months. Subject satisfaction as well as post-treatment immediate response and treatment-associated pain scores were also evaluated. RESULTS: Statistically significant improvement in CEA was seen in both arms at the 1-, 2-, and 3-month post-baseline visits (P < 0.01). Only Arm 1 presented statistically significant improvement in CEA (P < 0.001) at 6 months post baseline with a mean score of 1.6 (almost clear-mild) compared with 3.2 at baseline. Arm 1 showed significantly greater mean vessel size improvement at 3 months (P < 0.01) and 6 months (P < 0.05) post baseline compared to Arm 2. Significantly greater improvement (P < 0.05) in the investigator GAI score was reported at the 2- and 6-month follow-ups compared with Arm 2. Subject GAI scores showed statistically significant greater improvement in Arm 1 compared with Arm 2 at both the 3- and 6-month follow-ups (P < 0.01). There were no complications or long-term effects associated with PDL or topical oxymetazoline treatments. CONCLUSION: The prospective trial verifies a safe, enhanced clinical outcome with the combination of PDL therapy and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea patients. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.