BACKGROUND:Menopause is a normal feature of the female aging process that commonly occurs during the 6th decade of life. During perimenopause, many negative effects begin to occur affecting the skin that are associated with decreasing production of estrogen, progesterone, and testosterone. Estrogen supports the extracellular matrix, collagen production, and dermal blood supply, while progesterone promotes extracellular matrix formation, dermal blood supply, and dermal water retention. Decreased testosterone impacts cutaneous blood supply and sebum production, causing skin dryness. AIMS:The primary objective of the following consensus roundtable was to discuss best practices for aesthetic providers when treating patients with perimenopausal and menopause-related skin conditions. PATIENTS/METHODS:A roundtable discussion was held by several notable experts in their field during a special edition of the Thriving in Diversity webinar series on Friday, June 13, 2025. The discussion included a gynecologist, a plastic surgeon, and two dermatologists who provided their clinical experience and consensus recommendations for treating perimenopausal and menopausal patients. RESULTS:Numerous therapies are available to treat patients with perimenopausal and menopause-related skin conditions. These include hormone replacement therapy (HRT), topical estrogen therapy, topical retinoids, topical cosmeceuticals (moisturizers, signal peptides, growth factors, exosomes), dermal injectables and biostimulators, and energy-based treatments, each with varying beneficial effects. The experts in this panel find that hormone replacement therapy, topical estrogen, injectable poly-L-lactic acid, injectable hyaluronic acid, and carbon dioxide laser resurfacing are the most effective interventions for treating hormone-related skin changes. CONCLUSIONS:Although menopause ultimately affects all women and is likely to produce unwanted effects including undesirable aesthetic changes, numerous treatments are available to treat or mitigate these effects.
BACKGROUND:Glucagon-like peptide-1 (GLP-1) receptor agonists have been associated with cutaneous changes including accelerated skin aging and volume loss. The biological mechanisms underlying these effects remain poorly understood, with limited in vivo human data. OBJECTIVE:The aim of this study was to evaluate adipogenesis-associated cellular markers in subcutaneous adipose tissue of patients receiving GLP-1 receptor agonist therapy. METHODS:Abdominal adipose tissue biopsies from patients receiving GLP-1 receptor agonists and untreated controls were analyzed using multiplex immunofluorescence to quantify FSP1, CD90, CD105, CD73, and ERG and to characterize adipose-derived stem cells (ADSCs) and fibroblast populations. RESULTS:Baseline analysis of 10 adipose tissue samples demonstrated a statistically significant reduction in adipose-derived stem-cell counts in the GLP-1 group compared with controls (11.0 vs 44.8 cells/mm2, p = .039), representing an approximately four-fold decrease. CD90+ cell counts were also significantly lower in the GLP-1 group (p = .047). Fibroblast populations were not significantly different between groups, suggesting selective depletion of the stem-cell compartment. CONCLUSION:This is the first in vivo human study demonstrating a significant reduction in the ADSC population in patients on GLP-1 receptor agonist therapy. Selective depletion of ADSCs offers a potential mechanism for the accelerated skin aging changes in this population beyond weight loss alone.
Currently, available technologies and procedures enable aesthetic dermatologists to provide their patients with beneficial treatment outcomes for a wide variety of skin conditions. These treatments range from laser resurfacing and radiofrequency procedures to chemical peels and microneedling. The concept of integrated skincare is based on the application of adjunct therapies before, during, or after cosmetic medical procedures to promote healing, minimize discomfort, shorten down-time, and enhance overall aesthetic outcomes. Numerous peer-reviewed studies have demonstrated the benefit of combining a variety of adjunct treatments with cosmetic procedures. The concurrent application of integrated skincare can improve these skin-related issues and provide patients with greater global outcomes. The primary objective of the following consensus roundtable was to discuss best practices for aesthetic providers with or without dermatological training when treating patients with aging skin complaints and review considerations for evaluating patients interested in cosmetic procedures with concomitant skin issues, such as skin dyschromias, lines, and wrinkles. A roundtable discussion was held by several notable experts in their field during a special addition to the Thriving in Diversity webinar series on Saturday, July 8, 2023. The discussion included four leading dermatologists, one oculoplastic surgeon, and one facial plastic surgeon who provided their clinical experience and consensus recommendations for applying integrated skincare in the aesthetic medical practice. J Drugs Dermatol. 2025;24(1):47-53. doi:10.36849/JDD.7999.
BACKGROUND:A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction. OBJECTIVES:To further evaluate the efficacy and safety of CBL-514 for abdominal subcutaneous fat reduction. METHODS:In this single-blind, randomized, parallel-group, placebo-controlled Phase 2 trial, 76 participants were randomized (2:1) to receive up to 4 CBL-514 treatments (2 mg/cm2, maximum 600 mg/treatment) or placebo, administered subcutaneously to the abdomen every 4 weeks. Two follow-up visits were conducted at 4 and 8 weeks following final treatment. Changes in abdominal subcutaneous fat thickness and volume were measured by ultrasound. The primary endpoint was the proportion of participants with subcutaneous fat volume loss of ≥150 mL from baseline compared with placebo. RESULTS:In the intention-to-treat population, a significantly higher proportion of CBL-514-treated participants achieved ≥150 mL subcutaneous fat volume reduction from baseline compared with placebo-treated participants at both follow-up visits. At 8 weeks post final treatment, 69.6% of CBL-514-treated participants lost ≥150 mL subcutaneous fat, compared with none in the placebo group (P < .001). Moreover, 60.9% of participants in the CBL-514 group further achieved the ≥200 mL subcutaneous fat loss threshold. Of the 28 participants in CBL-514 group (n = 50) who lost ≥150 mL subcutaneous fat, 42.9% (12/28 participants) achieved this target after a single treatment. The most common treatment-emergent adverse events were injection site reactions and were of mild-to-moderate severity. CONCLUSIONS:CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, promising alternative therapy for effective targeted subcutaneous fat reduction. LEVEL OF EVIDENCE: 2:
Evolysse Form (EVLF) and Evolysse Smooth (EVLS) (Symatese, Chaponost, France) are new hyaluronic acid fillers created using an innovative cold-crosslinking process. The authors of this study aim to collect safety and effectiveness data on new cold-crosslinked fillers to support the US approval for the correction of moderate-to-severe dynamic facial wrinkles and folds. In this randomized, controlled, split-face study, 140 patients with moderate-to-severe nasolabial folds (NLFs) received a cold-crosslinked filler in 1 NLF (EVLF = 70, EVLS = 70) and a traditionally crosslinked filler, Restylane-L (RESL), in the contralateral fold and were followed through 12 months with an optional retreatment at that time point and subsequent 3 months of safety follow-up. The primary endpoint of mean Wrinkle Severity Rating Scale change from baseline to Month 6 as rated by the photographic review panel demonstrated noninferiority and statistical superiority for the cold-crosslinked fillers. Blinded evaluator Wrinkle Severity Rating Scale assessments showed a mean change from baseline that was statistically significantly better than RESL for EVLF at all visits through 12 months and for EVLS at 6 and 9 months. Most patients were responders on the Global Aesthetic Improvement Scale throughout the study, according to ratings by blinded evaluators, treating investigators, and patients. The FACE-Q appraisal of NLFs' overall mean score showed significant improvement from baseline (P < .0001) at all time points through Month 12 for all treatment groups. All treatments were well tolerated. The new cold-crosslinked fillers were shown to be safe and effective for correction of NLFs, with results lasting for 1 year.
Background: There is limited literature assessing cosmetic lip size preferences in darker-skinned individuals. Objective: To measure preinjection lip augmentation preferences and postinjection satisfaction using the revised Lip Fullness Scale (LFS) in female participants with Fitzpatrick Skin Type V and VI. Methods: Females, aged 21 and over, with Fitzpatrick Skin Type V and VI desiring lip augmentation were recruited from a high-volume outpatient facial plastic surgery clinic. The LFS scale was administered pre- and postinjection. FACE-Q scales which measure patient reported outcomes for facial cosmetic procedures were administered postinjection. Results: Twenty-two female subjects participated in the study. The average age was 33.2 years (SD = 8.1). Fourteen participants (14) were Fitzpatrick V and eight (8) were Fitzpatrick VI. The average preinjection self-assessment LFS was 3.5. The final average postinjection self-assessment LFS score was 4.3. The increase in final postinjection LFS scores was found to be statistically significant with a p-value <0.001 when compared with preinjection LFS scores. Patients reported high satisfaction on postinjection FACE-Q. Conclusion: Patients with darker skin may prefer marked to very marked lip fullness, and physicians should be conscientious in understanding patients' individual perspectives and aesthetic goals.[Box: see text].
OBJECTIVE:The authors sought to evaluate a flexible, hyaluronic acid (HA) filler, Restylane® Defyne™ (HADEF) (Galderma), for combined treatment of chin, nasolabial folds (NLFs), and marionette lines (MLs), in a predefined stepwise order, comparing Down-up (ie, chin first) versus Top-down (NLFs and MLs first) treatment approaches. This postmarketing study complements prior pivotal investigations that demonstrated the safety and effectiveness of HADEF treatments of the lower face, by providing a standardized treatment algorithm for combining several treatment areas in the lower face. METHODS:HADEF was injected at Day 1 in the first treatment area and at Week 3 in the second area (randomized to either Down-up or Top-down order), with optional touch-up (any area) at Week 6. Assessments included Global Aesthetic Improvement Scale (GAIS), skin firmness, facial harmony, patient satisfaction, and safety until Week 9. RESULTS:Both approaches achieved similar, favorable results at Week 9, with 100% of patients in both groups (Down-up, n=31; Top-down, n=29) demonstrating aesthetic improvement on the GAIS, improved skin firmness and facial harmony, and natural-looking results. Of patients seeking aesthetic improvement of the submental area, 95% in the Top-down group and 100% in the Down-up achieved improvement. Patient-reported endpoints supported these results, with high satisfaction throughout the study. HADEF was well tolerated throughout the study. LIMITATIONS:The results should be considered indicative rather than definitive given the post-marketing design of the study. CONCLUSION:Both stepwise approaches may be used for administering HADEF when treating the combined areas of chin, NLFs, and MLs.
BACKGROUND:Lip augmentation using dermal fillers is increasingly popular, but often requires large volumes and regular touch-ups, whereas poor techniques and product selection can result in unnatural-looking lips. The RHA collection was designed to have less rigidity, allowing the products to adapt to facial animation. In particular, RHA3 has been approved in Europe for lip volumization. OBJECTIVES:The authors of this study aimed to evaluate the effectiveness and safety of RHA3 vs an active comparator for lip augmentation in the US population. METHODS:This was a randomized, controlled, double-blinded, multicenter clinical study. The primary endpoint aimed to demonstrate the noninferiority of RHA3 vs the comparator using the Teoxane Lip Fullness Scale (TLFS), assessed by the blinded live evaluator, 12 weeks after treatment. Secondary objectives included improvement on the TLFS, Global Aesthetic Improvement Scale, patient satisfaction, and natural look/feel of the lips up to 52 weeks. Safety assessment covered adverse events (AEs), common treatment reactions, and injection site pain. RESULTS:A total of 202 patients were enrolled. RHA3 was considered statistically noninferior to the comparator for lip augmentation among patients with TLFS Grades 1 to 3. It provided sustained lip volume enhancement over time, with high rates of aesthetic improvement and patient satisfaction. Most RHA3-treated patients achieved a natural look and feel of the lips that was maintained throughout the study period. Most AEs were mild to moderate, with no late-onset reactions or angioedema reported. CONCLUSIONS:RHA3 was effective for lip augmentation, providing sustained aesthetic improvement, high satisfaction, and good tolerability. These findings support the use of RHA3 as a uniquely dynamic option for natural-looking lip augmentation. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):
The use of neuromodulators for cosmetic purposes has a remarkable safety record; nevertheless, unwanted effects can and do sometimes occur when neurotoxins are used for facial rejuvenation, such as neutralizing antibodies and eyelid ptosis. The primary objective of the following roundtable discussion was to review the most commonly reported complications from neurotoxins and summarize considerations for reducing the risk of complications. A roundtable discussion was held by 5 notable experts in their field during a special addition of the Thriving in Diversity webinar series on Thursday, February 15, 2024. Three presenters were provided with an opportunity to share their knowledge. Common complications associated with the use of neuromodulators include lack of response due to neutralizing antibody formation and eyelid ptosis. Common complications, such as neutralizing antibodies, can often be prevented by avoiding known risk factors. The use of topical alpha adrenergic agonists can often improve the appearance of eyelid ptosis. The cosmetic use of neuromodulators remains extremely safe, and serious adverse events rarely occur.
Background: Patient-reported outcome measures (PROMs) for hair loss focus mainly on Alopecia Areata. We created a PROM (i.e., HAIR-Q) that is applicable to any hair loss condition. The HAIR-Q measures satisfaction with hair. Patients/Methods: Concept elicitation interviews were conducted and analyzed to develop a draft scale. Content validity was established through multiple rounds of patient and expert input. Psychometric properties of the scale were examined in an online sample (i.e., Prolific) using Rasch measurement theory (RMT) analysis. Test-retest reliability and tests of construct validation were examined. Results: Content validity of a 22-item draft scale was established with input from 11 patients, 12 experts and an online Prolific sample of 59 people who had a variety of hair loss treatments. In the RMT analysis (n = 390), 8 items were dropped. Data for the 14-item scale fit the Rasch model (chi(2) = 89.85, df = 70, p = 0.06). All 14 items had ordered thresholds and good item fit. Reliability was high with person separation index and Cronbach alpha values >= 0.91, and intraclass correlation coefficient of 0.94 based on a sample of 97 participants. Higher (better) scores on the scale were associated with having more hair, looking younger than ones' age, satisfaction with hair overall, being less bothered by hair loss, and for those who had a hair loss treatment in the past year, being more satisfied with their hair now than before treatment (p < 0.001). Conclusion: The HAIR-Q evidenced reliability and validity and can be used in research and to inform clinical care to measure satisfaction with hair from the patient perspective.
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.
Following the advent of glucagon-like peptide-1 receptor agonists (GLP-1RAs), 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-1RAs, 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-1RAs 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, and 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-1RAs, 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-1RAs in modulating adipose tissue dynamics, thereby contributing to accelerated aging through metabolic, structural, and hormonal pathways. LEVEL OF EVIDENCE: 5:
Background: Lip fullness has emerged as a sought-after aesthetic feature. RHA® 3 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds. Its distinct rheological attributes, marked by high strength and effective stretch, position it as an ideal, versatile candidate for dynamic lip volumization.
BACKGROUND:In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amid an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by nonacademic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES:The aim of this study was to identify levels of competency for the aesthetic practitioner and necessary achievement milestones during the educational path from novice to expert injector. METHODS:A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection, and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS:Regardless of medical specialty and experience level, averages of 3.85 (1.8) years, 786.4 (2628) filler injections and 549.9 (1543) toxin injections were estimated to progress from novice to advanced injector, while averages of 6.10 (3.7) years, 1842.2 (4793) filler injections, and 1308.5 (3363) toxin injections were estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions where it is most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS:In this study we establish an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1840 filler and 1310 neuromodulator injections for expertise. We also identify critical facial regions for targeted treatments by different expertise levels. LEVEL OF EVIDENCE: 4:
Background: OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural-looking outcomes is a frequently reported treatment barrier.Aims: Examine patient-reported outcomes (PROs) after onabotA treatment for UFL.Methods: A post hoc analysis was conducted on two 12-month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (+/- 24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin-naive adults achieving a >= 2-grade improvement in UFL severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). Data were further stratified into millennials and men.Results: At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, >= 80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, >= 50% reported positive impacts on self-perceived appearance and psychological well-being, but millennials had higher, and men had lower odds of reporting these improvements.Conclusions: Participants achieving a >= 2-grade improvement in UFL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self-perceived appearance and psychological well-being. These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.
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.
Background In an evaluator-blinded, randomized controlled trial, the hyaluronic acid soft-tissue filler VYC-20L injectable gel was safe and effective for correcting volume deficits and retrusion in the chin. Objectives The objective of this subanalysis was to compare responder rates obtained with photographic vs live assessments. Methods Participants were randomized 3:1 to VYC-20L treatment or a 6-month, no-treatment control period followed by optional treatment. Responder rates (≥1-point improvement from baseline on the validated Allergan Chin Retrusion Scale [ACRS]) obtained with photographic assessments and live assessments at Month 6 were compared. Prespecified subgroup analyses compared responder rates by baseline ACRS severity, filler volume, cannula usage, and investigation site. Results VYC-20L was effective for chin augmentation as evaluated with both live and photographic assessments. The ACRS responder rates at Month 6 were 91.8% with live assessments and 56.3% with photographic assessments. Consistently higher response rates were observed by live vs photographic assessment regardless of baseline ACRS severity, filler volume, cannula usage, and investigation site. Conclusions Live assessment of ACRS response after VYC-20L treatment resulted in higher responder rates than photographic assessment, supporting the use of live assessment for this indication to approximate real-world clinical practice. Level of Evidence: 1
Background:The Satisfaction with Face Overall and Psychological Function scales are the most frequently used FACE-Q Aesthetics module scales. This study aimed to extend their range of measurement by adding and testing new concepts. We aimed to create FACE-Q Aesthetics item libraries. Methods:In-depth concept elicitation interviews were conducted. Concepts were formed into items and refined through multiple rounds of patient and expert input. The items were tested with people living in the United States, Canada, and the United Kingdom who had minimally invasive facial aesthetic treatments. Participants were recruited through an online platform (ie, Prolific). Psychometric properties were examined using Rasch measurement theory analysis, test-retest reliability, and construct validity. Results:We conducted 26 interviews. New concepts were developed into items and refined with input from 12 experts, 11 clinic patients, and 184 Prolific participants. A sample of 1369 Prolific participants completed 52 appearance and 22 psychological items. After removing 10 and 2 items respectively, the psychometric tests provided evidence of reliability with the person separation index, Cronbach alpha, and test-retest reliability values without extremes of 0.88 or more. For validity, lower scores were associated with looking older than one's age, being more bothered by facial skin laxity, treatment wearing off, and having deeper lines on Merz Assessment scales. Short-form scales formed from the 42 appearance items provide examples of item library application. Conclusions:This study provides an innovative means to customize scales to measure appearance and psychological function that maximizes content validity and minimizes respondent burden in the context of minimally invasive treatments.
Background: With aging, repetitive contraction of the platysma leads to an increase in platysma prominence (PP), characterized by the accentuation of vertical neck bands and blunting of the jawline contour. Methods: This multicenter, double-blind, phase 2 study evaluated onabotulinumtoxinA treatment in adults with moderate to severe PP. Participants were randomized to receive 1 treatment of onabotulinumtoxinA low dose (LD), onabotulinumtoxinA high dose (HD), or placebo, and were followed up for 4 months. Efficacy end points were achievement of a 1 grade or greater improvement on both the left and right sides at day 14 at maximum contraction as assessed by the investigator (primary) or by participants (secondary) using validated scales. Safety was evaluated throughout. Results: Participants in the modified intent-to-treat population (n = 164) had a mean age of 50 years; 95.1% were women and 93.9% were White. The primary end point was met for both onabotulinumtoxinA groups, with investigator-assessed 1 grade or greater improvement in 77.8% (LD) and 88.2% (HD) versus 12.0% (placebo) of participants on day 14 (P < 0.0001 versus placebo). Based on participant self-assessment, 75.9% (LD) and 88.2% (HD) versus 18.0% (placebo) achieved 1 grade or greater improvement on day 14 (P < 0.0001 versus placebo). Most treatment-related adverse events were procedure-related, transient, and mild in severity. The most frequent onabotulinumtoxinA-related adverse event was neck muscle weakness, reported in the HD group. Conclusion: OnabotulinumtoxinA was effective in improving the appearance of PP based on both investigators’ and participants’ ratings. Treatment was well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
BACKGROUND:Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE:To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS:Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS:Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001). CONCLUSION:LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.