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.

Comparing the Safety and Effectiveness of Microfocused Ultrasound: Standard vs Targeted Tissue Protocol in Lifting and Tightening the Lower Face and Upper Neck.

BACKGROUND: Micro-focused ultrasound with visualization (MFU-V) delivers energy to specific soft tissue layers beneath the epidermis with the ability to lift and tighten the lower face and neck.  Objective: To determine the efficacy of microfocused ultrasound with visualization (MFU-V) using a standard treatment line protocol versus a customized treatment line protocol based on the patient's unique anatomy targeting the superficial muscular aponeurotic system and fibrous septae for lifting and tightening of the lower face and neck. METHODS: This was a single-center, prospective, randomized, investigator-blinded clinical trial. 51 subjects were randomized to receive a single treatment of MFU-V targeting the lower face and neck using either a standard or custom treatment protocol.   Results: Subjects in both standard and custom treatment groups noted a greater than one-point improvement in jawline laxity. Three-dimensional photography measurements also demonstrated lifting of the lower face and neck in both treatment groups. CONCLUSION: Custom and standard treatment MFU-V protocols produce a safe and effective treatment for tightening and lifting the lower face and neck. Custom treatment protocols aid in maximizing results for patients with variations in the anatomy of the lower face and neck.  J Drugs Dermatol. 2024;23(4):7647.     doi:10.36849/JDD.7647.

A Practical Algorithm Integrating Skin Care With Nonenergy and Injectable Dermatologic Procedures to Improve Patient Outcomes and Satisfaction.

BACKGROUND: The most rapidly increasing medical aesthetic procedures for facial antiaging comprise nonenergy and injectable treatments. Currently, standards for skin care before, during, and after nonenergy and injectable treatments are lacking. The algorithm on supportive skin care for facial antiaging nonenergy and injectable treatments aims to stimulate healing, reduce downtime, and improve comfort and treatment outcomes.  Methods: A panel of 7 global physicians employed a modified Delphi method and reached a consensus on an algorithm for supportive skin care for nonenergy and injectable antiaging treatments based on the best available evidence and the panel members’ clinical experiences and opinions. RESULTS: The algorithm has a pretreatment (starts 2 – 4 weeks before the procedure) and treatment or ongoing (day of treatment) section, followed by care after the procedure (0 – 7 days) and follow-up care (1 – 4 weeks after the procedure). Applying a broad-spectrum sunscreen with an SPF 30 or higher, combined with protective measures, such as wearing a wide-brimmed hat and sunglasses, is recommended to protect the face from sun exposure. Dyschromia is a significant concern for those with richly pigmented skin. Clinicians may recommend skin care using a gentle cleanser and moisturizer containing vitamins C and E, retinoid, or other ingredients, such as niacinamide, kojic acid, licorice root extract, azelaic acid, and tranexamic acid, depending on the patient's facial skin condition. CONCLUSION: Nonenergy and injectable procedures combined with skin care or topical treatments may improve outcomes and patient satisfaction. Topical antioxidants and free radical quenchers can combat photodamage and may offer a safe alternative to topical hydroquinone.    J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.7918.

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.

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.

BACKGROUND: The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control. METHODS: Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12. RESULTS: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections. CONCLUSION: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments. CLINICALTRIALS: gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305.        doi:10.36849/JDD.7729.

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.

Decoding the Implications of Glucagon-Like Peptide-1 Receptor Agonists on Accelerated Facial and Skin Aging.

Following the advent of glucagon-like peptide-1 receptor agonists (GLP1RA), subsequent unintended effects such as accelerated facial aging and altered skin health have been noted. This review delves deeper into the causative underlying mechanisms and provides insights into the intricate relationship between GLP-1RA, adipose tissue, and premature facial aging, thereby highlighting the need for a nuanced understanding of their effects on facial alterations and skin health. Studies exploring the potential effects of GLP-1RA on facial alterations and offering insights into the possible underlying mechanisms, causes and clinical implications were included. The accelerated facial aging and altered skin health observed in GLP-1RA patients appears to be multifactorial, involving loss of dermal and subcutaneous white adipose tissue, altered proliferation and differentiation of adipose-derived stem cells (ADSCs), and impacts on the production and secretion of hormonal and metabolic factors. These changes compromise the structural integrity and barrier function of the skin and may lead to diminished facial muscle mass, further exacerbating the appearance of aging. The insights presented call for a paradigm shift in the clinical management of facial changes induced by GLP-1RA, with a focus on treatment strategies aimed at targeting ADSC stimulation. These include autologous fat transfers to reintroduce cells rich in ADSCs for rejuvenation, composite fat grafting combining autologous fat with/without stromal vascular fraction, and the strategic use of soft tissue fillers for volume restoration and biostimulation. This review highlights the potential role of GLP-1RA in modulating adipose tissue dynamics, contributing to accelerated aging through metabolic, structural, and hormonal pathways.

The role of topical capsaicin gel in pain management during microfocused ultrasound treatment for neck laxity.

BACKGROUND: The transient receptor potential vanilloid 1 (TRPV1) provides a heat and pain sensation (nociception). Capsaicin, a TRPV1 agonist, has been shown to induce a refractory period in the nerve terminal expressing TRPV1 and create long-term nerve terminal defunctionalization. OBJECTIVE: To evaluate the efficacy of capsaicin for pain reduction during microfocused ultrasound with visualization (MFU-V) treatment. METHODS AND MATERIALS: A randomized, split-side study including 24 subjects was conducted. A combined 0.025% capsaicin gel and topical anesthetic were randomly applied on one side of the neck, and a topical anesthetic monotherapy was applied on the contralateral side for 30 min before MFU-V treatment. Pain score (visual analog scale, 0-10) was evaluated at T1 (before MFU-V), T2a (after the 4.5-mm transducer treatment), T2b (after the 3.0-mm transducer treatment), and T3 (after the entire treatment). Side effects were recorded. RESULTS: Mean pain scores at T2a for combined and single regimens were 5.19 (±2.26) and 6.91 (±1.72), respectively (p < 0.001). The capsaicin-treated side had a lower pain score at T2b and T3 (p < 0.001). Redness was longer on the capsaicin-treated side (112.67 vs. 10.68 min, p < 0.001). No other adverse events including contact dermatitis were reported. CONCLUSION: A single application of a combined 0.025% capsaicin gel with topical anesthesia produces a significantly lesser pain score during the MFU-V treatment. Defunctionalization of TRPV1 may explain the alleviation of painful sensations caused by heat from MFU-V.

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.

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.

Clinical Trial of Alpha and Beta Defensin Skin Care Regimen for Improvement of Periocular Wrinkles.

BACKGROUND: Defensins recruit leucine-rich repeat-containing G protein-coupled receptor 6 positive (Lgr6+) stem cells which ultimately regenerate new basal stem cells, healthy keratinocytes, and nascent hair follicles. Thus, defensins are an exciting, novel therapy for the reversal of skin aging. METHODS: This is a multicenter, prospective, open-label clinical trial. Twenty healthy subjects, aged 45-80, with Fitzpatrick skin types II-IV were enrolled in the study. A skin care regimen containing alpha-defensin 5 and beta-defensin 3 were applied to the face twice daily for 12 weeks. This skin care regimen contains a greater percentage of defensins than that already studied.7 All participants underwent imaging at baseline, day 30, day 60, and day 90. Primary endpoints included investigator scoring on the Fitzpatrick-Goldman wrinkle scale and percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance. Secondary endpoints were investigator Global Aesthetic Improvement Score (GAIS), subject GAIS, and investigator assessment of tolerability. A final subject questionnaire was completed on day 90.  Results: Based on the Fitzpatrick-Goldman wrinkle scale, a statistically significant improvement was noted in both wrinkling and elastosis from baseline to day 90. 30% of subjects were rated as much improved and 50% of subjects were rated as improved on the physician GAIS at the 90 day follow up. Improvements were noted in all aspects of skin quality including wrinkles, laxity, dyschromia, erythema, texture, and radiance.  Conclusion: The enhanced formula containing increased concentrations of alpha-defensin 5 and beta-defensin 3 is a safe and efficacious topical therapy for the treatment of periorbital rhytids. CITATION: Hartman N, Loyal J, Taub A, et al. Clinical trial of alpha and beta defensin skin care regimen for improvement of periocular wrinkles. J Drugs Dermatol. 2023;22(9):874-880. doi:10.36849/JDD.7184.

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

BACKGROUND: Dyschromia can be caused by abnormalities in the increased production and/or reduced clearance of pigmentation in the skin. Causes of hyperpigmentation include excessive sun exposure, medications, hormones, post-inflammatory hyperpigmentation (PIH), and medical disorders, such as melasma. A novel topical product was recently developed, which contains actives that have been validated through in vitro studies to counteract various steps in the pigmentation pathways, including photodamage, PIH, and melasma. This study evaluates the safety and efficacy of this product for facial dyschromia. STUDY DESIGN: Subjects with mild to severe facial dyschromia were enrolled to receive either the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) or hydroquinone 4% topical to apply twice daily. Both cohorts received cleanser, sunscreen, and moisturizer. Follow-up occurred at weeks 4, 8, and 12. Blinded investigators used the modified Melasma Area Severity Index (mMASI) and modified Griffiths scales at baseline and final follow-up. Tolerability assessments and subject questionnaires were completed. RESULTS: Forty-three subjects were enrolled and randomized to either the novel topical product (n=22) or hydroquinone 4% (n=21) cohort. At week 12 follow-up, subjects using the novel topical product had significant improvements in mMASI scores for the right cheek (P=0.0097), left cheek (P=0.0123), combined cheeks (P=0.0019), and total facial area (P=0.0046). In contrast, subjects using hydroquinone 4% had no significant improvements in any of these areas. Although both cohorts demonstrated improvements in dyschromia and skin tone, the novel topical product also offered significant improvements in skin radiance (P=0.0015) and skin texture (P=0.0058), which the hydroquinone 4% cohort did not demonstrate. The hydroquinone 4% cohort experienced 5 adverse events, while there were no adverse events associated with the novel topical product. Subjects in the hydroquinone 4% cohort also more frequently experienced burning/stinging, tingling, itching, erythema, and dryness. CONCLUSION: A novel topical product with PATH-3 Technology, designed to counteract various steps in pigmentation pathways, has been demonstrated to be safe and effective in treating facial dyschromia. CITATION: Wang JV, Fabi SG, Mraz Robinson D, et al. A multi-center, randomized, blinded clinical study evaluating the efficacy and safety of a novel topical product for facial dyschromia. J Drugs Dermatol. 2023;22(4):333-338. doi:10.36849/JDD.7340.

Microtoxin for Improving Pore Size, Skin Laxity, Sebum Control, and Scars: A Roundtable on Integrating Intradermal Botulinum Toxin Type A Microdoses Into Clinical Practice.

BACKGROUND: In aesthetic clinical practice, botulinum toxin type A (BoNT-A) is best known for its use as a neuromodulator for the treatment of dynamic facial lines; however, when injected intradermally as microdroplets, BoNT-A can improve skin quality and overall skin appearance. OBJECTIVES: To discuss key aspects of microtoxin use in clinical practice and provide expert guidance on utilization. METHODS: As part of a continuing medical education lecture series and roundtable, the authors discussed key aspects of microtoxin patient selection, injection technique, and safety. RESULTS: The experiences of expert faculty are shared here. Clinical experience is consistent with reported data. Microtoxin can be used to reduce pore size, sebum production, rosacea, acne, and fine lines, and to improve jawline and neck definition. Intradermal injection can also be employed for the improvement of transverse neck lines as well as for the safe prevention and management of scars and keloids. CONCLUSIONS: Expanding the use of BoNT-A, a predictable, minimally invasive, and affordable treatment to address commonly encountered complaints is appealing. The authors have found that making patients aware of microtoxin as a treatment option results in an increased interest in and utilization of BoNT-A, and high satisfaction among appropriately selected patients.

Patient Preferences and Perceptions Concerning Aesthetic Providers and Social Media.

BACKGROUND: With the rise of social media, aesthetic providers have established a presence on social media. However, there has been little research to evaluate how patients perceive these aesthetic providers and what they desire to see on their professional accounts. OBJECTIVES: This study aimed to evaluate the social media preferences and perceptions of patients who undergo aesthetic procedures. METHODS: A survey was sent to a random sample of US individuals; 651 (32%) identified that they underwent aesthetic procedures. Descriptive statistics were utilized to analyze participants and groups were compared with chi-square analyses. RESULTS: Our sample had a majority of females (57% female, 43% male). An aesthetic medical provider's social media presence had a positive impact on 41% of respondents; a minority of respondents (9%) preferred no social media presence. Fifty-five percent of respondents indicated they would prefer to see a provider with a blue checkmark. With regard to content published, 70% of respondents found it important that a provider show before and after photographs. One-third of respondents indicated they would prefer not to see personal content (n = 236, 36%). CONCLUSIONS: A social media presence is not a strict requirement for success, but 41% of respondents reported a social media presence positively impacted their desire to see the provider as a patient. Patients preferred certain characteristics, such as verification and before and after photographs. Aesthetic providers should take care when determining what content to publish to their social accounts and should consider focusing on educational, promotional, and family/interpersonal content.

Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.

BACKGROUND: Infraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows. OBJECTIVE: The objective of the current analysis was to examine patient-reported outcomes from the clinical study. METHODS: Participants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend. RESULTS: The modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend. CONCLUSIONS: The current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year.

Update: Cellulite Therapies and Optimizing Treatment Combinations.

Cellulite in the proximal lower extremities is a reported concern among many adult females. The unsightly appearance of cellulite leads many affected individuals to seek treatment by trained specialists. The objective of this review is to provide the reader with an update on new and innovative therapies for cellulite including various treatment combinations to maximize therapeutic outcomes, and strategies for minimizing adverse events. The availability of new technologies and the results from recent clinical trials provide additional tools and data to consider when creating treatment plans for cellulite patients. This update to previous treatment recommendations is based on the most recent developments in cellulite management including the personal experiences of the authors with an emphasis on injectable enzymes, acoustic subcision, targeted verifiable subcision, and biostimulators. Formal clinical studies are warranted to compare various treatment modalities and further investigate combination regimens.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: 3-Month Results.

BACKGROUND: Cellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS). OBJECTIVES: The objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women. METHODS: Adult women aged 21 to 55 years and a BMI < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days. RESULTS: Seventy-four female participants with a mean BMI of 24.8 ±â€…2.7 and age of 41.4 ±â€…7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ±â€…0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days. CONCLUSIONS: TVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women.

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months.

BACKGROUND: Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing targeted verifiable subcision (TVS) for the treatment of cellulite were met at 3 months postprocedure and have been published. Final, 12-month data describing durability of treatment effect and safety are presented here for the first time. OBJECTIVES: The authors sought to evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed employing the Avéli device (Revelle Aesthetics, Inc.; Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. METHODS: Effectiveness was determined by 3 independent physicians employing the Cellulite Severity Scale and Global Aesthetic Improvement Scale to assess improvement of baseline photographs when compared with 3-, 6- and 12-month posttreatment photographs. Blinded participant-reported outcomes and safety evaluations were also performed at all postprocedure time points. RESULTS: Clinically significant improvement in primary endpoint Cellulite Severity Scale scores were sustained out to 1 year, improving by 1.50 (P < .0001) at 3 months, 1.54 points at 6 months, and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12-month visit. CONCLUSIONS: A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.