A Retrospective Analysis of Safety in Participants Treated with a Hybrid Hyaluronic Acid and Calcium Hydroxyapatite Filler.

Background: Limited long-term safety data are published on HA/CaHA/L, a hybrid dermal filler combining hyaluronic acid (HA), calcium hydroxyapatite (CaHA), and lidocaine (L). Methods: This retrospective multicenter study assessed treatment-emergent adverse events (TEAEs) in adults treated with HA/CaHA/L. The full analysis set (FAS) included eligible consented adults (N = 403); the long-term safety analysis (LTSA) set included FAS participants with greater than or equal to 12-months HA/CaHA/L exposure (n = 243). Results: Participants were majority female (94.0%), with Fitzpatrick skin phototypes II/III (80.1%) and a mean age of 50.1 years. Most participants (86.4%) received one HA/CaHA/L treatment. The median time between participants' first HA/CaHA/L treatment and chart review was 15.4 months. Participants received a mean of 2.2 mL (0.5-8.9 mL) filler per treatment. Treated areas were predominantly malar (71.2%) and mandible (69.7%) regions. Most participants (95.0%) had one or more aesthetic treatments other than HA/CaHA/L [eg, other dermal fillers (84.1%), botulinum toxin (63.3%)]. Nineteen (4.7%) FAS participants had 20 documented TEAEs; most (3.5%, n = 14 participants) were mild in severity. Twelve TEAEs in 11 participants (2.7%) were related to HA/CaHA/L: induration (three, 0.7%), edema (3, 0.7%), and implant site nodules (five, 1.2%), which were noninflammatory and likely related to product placement. Among the LTSA, 15 (6.2%) participants had 16 documented TEAEs (six edema, five implant site nodules, one inflammation, three skin induration, one hypersensitivity); most were mild in severity. Nine TEAEs in eight participants (3.3%) were HA/CaHA/L-related. No treatment-emergent serious AEs were reported. Conclusion: The data from this noninterventional retrospective study support the favorable longer term (>12 month) safety profile of HA/CaHA/L.

Quantifiable Changes in the Submental Area and Mandible Border After Dual-Modality Treatment With ATX-101 and VYC-20L for Overall Improvement in Jawline Contour.

BACKGROUND: A phase 4, prospective, open-label, multicenter study showed that treatment with deoxycholic acid injections (ATX-10) followed by a hyaluronic acid filler (VYC-20L) is safe and effective for reducing submental fullness and improving jawline definition. OBJECTIVE: To quantify changes in the jawline and submental area using 3-dimensional (3D) photogrammetry and conduct an immunohistochemical analysis of submental tissue.  Methods: Participants received 1 to 6 ATX-101 treatments (8 weeks apart) followed by VYC-20L (optional touch-up after 14 days). Changes from baseline in jawline and submental volumes, submental major and minor strain events, submental skin displacement, and submental angles were quantified using photogrammetry. Submental skin biopsies (N=13) were excised for histologic analysis. Treatment-emergent adverse events (TEAEs) were monitored. RESULTS: Fifty-three participants were treated. From baseline to the final study visit, the mean volume increased for the jawline and decreased for the submental area. There was a larger percentage change from baseline in the minor versus major strain event, indicating greater skin surface compression than expansion within the submental area. Mean change from baseline in submental skin position indicated superior and posterior movement from a lateral perspective, while the mean submental angle decreased between baseline and exit. Collagen I and III expression significantly increased from baseline (P<0.05). All participants reported at least 1 TEAE; the majority were mild or moderate in severity. CONCLUSIONS: Dual-modality treatment with ATX-101 and VYC-20L reduces submental fat and improves jawline definition with quantifiable changes in jawline volume, submental volume, strain, skin displacement, and angle, as well as collagen expression. J Drugs Dermatol. 2024;23(1):1325-1331.        doi:10.36849/JDD.7458.

Development and Validation of a Photonumeric Scale to Assess Marionette Lines.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of marionette lines before and after treatment in clinical studies. OBJECTIVE: To describe the development and validation of a 5-point photonumeric marionette lines scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, and real and morphed subject images for each scale grade. Intrarater and interrater reliability was evaluated in initial scale validation (web-based review) ( N = 51 ) and live-subject validation ( N = 75 ) studies, each completed during 2 sessions. RESULTS: In the initial scale validation study, intrarater agreement for 2 physician raters was near perfect (weighted kappa = 0.92 and 0.94). Interrater agreement was excellent during sessions 1 and 2 (intraclass correlation coefficients of 0.94 and 0.95, respectively). In the live-subject validation study, intrarater agreement for 3 physician raters showed a strong correlation (mean weighted kappa = 0.77). Interrater agreement was high during live-subject validation sessions 1 and 2 (intraclass correlation coefficients = 0.89 for both sessions). CONCLUSION: This new marionette lines scale is a validated and reliable scale for physician rating of marionette line severity.

A Prospective, Open-Label, Multicenter, Real-World Study of VYC-17.5L Hyaluronic Acid Dermal Filler in the Lips.

Background: Hyaluronic acid (HA) injectable gels are used to define, enhance, and volumize facial regions, such as the lips, a common treatment area. Objectives: To evaluate the effectiveness and safety of the HA injectable gel Juvéderm Volift (Allergan, Aesthetics, an AbbVie Company Irvine, CA) with Lidocaine (VYC-17.5L) for lip augmentation in real-world clinical practice. Methods: This prospective, open-label, multicenter study initially designed for 6 months, then extended to 12 months, enrolled adults with an overall grade of minimal to moderate on the Lip Fullness Scale 2 (LFS2). Optional touch-up and repeat treatments occurred at day 14 and month 12, respectively. The primary endpoint was a ≥1-point improvement on the LFS2 at day 30. Other endpoints included improvements on the FACE-Q Satisfaction with Lips questionnaire, Global Aesthetic Improvement Scale (GAIS), subject assessment of natural look/feel of lips, and investigator assessment of dynamic lip lines upon animation. Injection site reactions (ISRs) and adverse events (AEs) were recorded. Results: Of 60 subjects enrolled (mean age, 36.8 years; 98.3% female), 59 were evaluable for efficacy at day 30; 13 (21.4%) received touch-up treatment. Thirty-six of 40 subjects completed the extension study (month 12). LFS2 responder rates were 93.2% at day 30 (primary endpoint) and 39.0% at month 12. Mean scores on the FACE-Q questionnaire improved from baseline by 45.2 points and 23.6 points at day 30 and month 12, respectively. Most subjects showed improvements on the GAIS. The majority of ISRs were mild/moderate; no serious AEs occurred. Conclusions: VYC-17.5L was effective and well tolerated for lip augmentation through 12 months posttreatment.

Rheologic and Physicochemical Characteristics of Hyaluronic Acid Fillers: Overview and Relationship to Product Performance.

Injections with hyaluronic acid (HA) fillers for facial rejuvenation and soft-tissue augmentation are among the most popular aesthetic procedures worldwide. Many HA fillers are available with unique manufacturing processes and distinct in vitro physicochemical and rheologic properties, which result in important differences in the fillers' clinical performance. The aim of this paper is to provide an overview of the properties most widely used to characterize HA fillers and to report their rheologic and physicochemical values obtained using standardized methodology to allow scientifically based comparisons. Understanding rheologic and physicochemical properties will guide clinicians in aligning HA characteristics to the facial area being treated for optimal clinical performance.

Clinical Relevance of Elastin in the Structure and Function of Skin.

Elastin is the main component of elastic fibers, which provide stretch, recoil, and elasticity to the skin. Normal levels of elastic fiber production, organization, and integration with other cutaneous extracellular matrix proteins, proteoglycans, and glycosaminoglycans are integral to maintaining healthy skin structure, function, and youthful appearance. Although elastin has very low turnover, its production decreases after individuals reach maturity and it is susceptible to damage from many factors. With advancing age and exposure to environmental insults, elastic fibers degrade. This degradation contributes to the loss of the skin's structural integrity; combined with subcutaneous fat loss, this results in looser, sagging skin, causing undesirable changes in appearance. The most dramatic changes occur in chronically sun-exposed skin, which displays sharply altered amounts and arrangements of cutaneous elastic fibers, decreased fine elastic fibers in the superficial dermis connecting to the epidermis, and replacement of the normal collagen-rich superficial dermis with abnormal clumps of solar elastosis material. Disruption of elastic fiber networks also leads to undesirable characteristics in wound healing, and the worsening structure and appearance of scars and stretch marks. Identifying ways to replenish elastin and elastic fibers should improve the skin's appearance, texture, resiliency, and wound-healing capabilities. However, few therapies are capable of repairing elastic fibers or substantially reorganizing the elastin/microfibril network. This review describes the clinical relevance of elastin in the context of the structure and function of healthy and aging skin, wound healing, and scars and introduces new approaches being developed to target elastin production and elastic fiber formation.

Considerations for the Use of Minimally Invasive Aesthetic Procedures for Facial Remodeling in Transgender Individuals.

There is increasing demand among transgender individuals for minimally invasive aesthetic procedures, such as injectable facial fillers and neurotoxins, for facial remodeling and transformation. These procedures may increase transgender individuals' satisfaction with their appearance and allow them to more effectively harmonize their physical appearance with their perception of self. There is currently a lack of information in the medical literature regarding guidelines for the use of these products in transgender patients. In this report, the authors provide experience-based treatment considerations and recommendations for use of minimally invasive facial aesthetic procedures in transgender patients, including case studies illustrating the use of these procedures for both male-to-female and female-to-male transitioning patients. This report highlights the success of minimally invasive methods for assisting transgender patients in achieving their facial remodeling goals. Clinicians play an integral role in the transitioning process for transgender patients, and facial transformation is a key element of this process. When conducted with sensitivity and attention to individual patient goals at varying stages of transition, facial procedures can be of great benefit in enhancing patients' self-perception and overall quality of life.

The Facial Aging Process From the "Inside Out".

The normal course of aging alters the harmonious, symmetrical, and balanced facial features found in youth, not only impacting physical attractiveness but also influencing self-esteem and causing miscommunication of affect based on facial miscues. With this evidence-based paper, the authors aim to provide a comprehensive overview of the latest research on the etiology and progression of facial aging by explaining the aging process from the "inside out," that is, from the bony platform to the skin envelope. A general overview of the changes occurring within each of the main layers of the facial anatomy is presented, including facial skeleton remodeling, fat pad atrophy or repositioning, changes in muscle tone and thickness, and weakening and thinning of the skin. This is followed by an in-depth analysis of specific aging regions by facial thirds (upper, middle, and lower thirds). This review may help aesthetic physicians in the interpretation of the aging process and in prioritizing and rationalizing treatment decisions to establish harmonious facial balance in younger patients or to restore balance lost with age in older patients.

OnabotulinumtoxinA Treatment for Moderate to Severe Forehead Lines: A Review.

With onabotulinumtoxinA approved for the treatment of glabellar and crow's feet lines and, most recently, for forehead lines (FHL), it is possible to simultaneously treat multiple areas of the upper face that are of high concern and treatment priority for aesthetically oriented individuals. This review aims to present key insights on the use of onabotulinumtoxinA for the treatment of moderate to severe FHL. METHODS: Double-blind, placebo-controlled registration trials of onabotulinumtoxinA for the treatment of FHL were included. Using findings from 3 such published studies, we discuss key concepts and clinical experience for the treatment of moderate to severe FHL with onabotulinumtoxinA (20 U in the frontalis and 20 U in the glabellar complex, with/without 24 U in crow's feet lines), including injection pattern, dose selection, efficacy and safety data, and considerations for patient selection. RESULTS: Across the 2 pivotal phase 3 studies, responder rates on investigator- and subject-assessed measures of appearance of FHL severity were significantly higher with onabotulinumtoxinA versus placebo for the treatment of FHL at day 30 (P < 0.0001), and results were maintained through 3 cycles of onabotulinumtoxinA. CONCLUSIONS: OnabotulinumtoxinA treatment also resulted in high patient satisfaction rates. The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected. OnabotulinumtoxinA is safe and effective and an appropriate option for patients with moderate to severe FHL encountered in clinical practice.

Improvement of Radial Cheek Lines With Hyaluronic Acid-Based Dermal Filler VYC-17.5L: Results of the BEAM Study.

BACKGROUND: Radial cheek lines (RCL) may convey an older, potentially less attractive appearance. OBJECTIVE: To evaluate the effectiveness of hyaluronic acid-based dermal filler VYC-17.5L for correcting RCL. MATERIALS AND METHODS: Fifty-three women (40-65 years) received injections of VYC-17.5L in both cheeks on Day 1 (optional Day 14 touch-up). Effectiveness was evaluated on Day 45 by subject-rated dynamic RCL improvement (Global Aesthetic Improvement Scale [GAIS]; primary end point) and independent, noninjecting investigator-rated GAIS; subject Self-Perception of Age (SPA); subject-assessed satisfaction with and natural look of treatment; and instrument-assessed changes in static and dynamic RCL roughness, amplitude, and texture (secondary end points). Safety assessments included injection site responses (ISRs). RESULTS: On Day 45, 98% of subjects rated RCL as improved or much improved (investigator rated: 95%). Subjects with same or older SPA before treatment (n = 38) perceived themselves as 2.0 and 5.5 average years younger after treatment, respectively. Day 45 mean satisfaction with and natural look of treated areas was 7.9/10 and 7.2/10, respectively. Treatment significantly improved RCL roughness, amplitude, and texture (all p < .001). Most common ISRs were hematoma (35.9%), bruising (30.2%), and irregularities/bumps (22.6%); most ISRs were mild. CONCLUSION: VYC-17.5L effectively corrected dynamic RCL, improved instrument-assessed indicators of skin quality, and resulted in younger age perception.

Understanding and treating different patient archetypes in aesthetic medicine.

BACKGROUND: Factors that motivate the treatment goals and expectations of the aesthetic patient reflect evolving social, cultural, and commercial influences. The aesthetic practitioner may often be faced with the challenge of first decoding the underlying motives that drive the patient to pursue their specific goals. The challenge for clinicians is further compounded by an increase in patient diversity with respect to race, ethnicity, age, and gender. AIMS: Simplify the path to patient interpretation with identification of primary patient archetypes. METHODS: The "Going Beyond Beauty" (GBB) initiative, consisting of 27 market research projects, was conducted to survey the primary goals and motives for seeking treatment aesthetic treatment. The results were stratified into predominant patient archetypes using segmentation analysis and then validated through online surveys, 1-to-1 interviews, and focus groups conducted with patients. An advisory board of internationally based aesthetic clinicians integrated the data with their own insights to further characterize each archetype. RESULTS: Data from over 54 000 participants in 17 different countries were distilled into four distinct patient archetypes based on motivating factors, aesthetic goals, initial treatment requests, and treatment opportunities and challenges. These archetypes were named Beautification, Positive Aging, Transformation, and Correction. CONCLUSION: The clinician's ability to recognize these four primary archetypes may provide a useful frame of reference to understand patient motives better, anticipate and manage their expectations, and provide the appropriate treatment guidance that best serves the long-term goals of their patients.

Earfold: A New Technique for Correction of the Shape of the Antihelix.

An absent or poorly defined antihelix often plays a central role in the perception of the prominent ear. A wide variety of otoplasty techniques have been described over the last 50 years that aim to reshape, create, or enhance the definition of the antihelix, which can, in turn, help to reduce the prominence of an ear. In addition to conventional suture and cartilage-scoring techniques, a permanent implantable clip system (Earfold® ) has recently become available that is placed using a minimally invasive approach performed under local anesthesia. In this review, we summarize conventional otoplasty techniques to correct the antihelix and compare these with the Earfold implantable clip system. Laryngoscope, 128:2282-2290, 2018.

OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study.

INTRODUCTION: This study evaluated safety and efficacy of onabotulinumtoxinA for moderate to severe glabellar lines (GL) following laser therapy in Chinese subjects. MATERIALS AND METHODS: Subjects (n = 173) were followed for 120 days following a single onabotulinumtoxinA (20 U) treatment for GL after recent laser therapy. Subjects completed validated patient-reported outcomes, including Facial Lines Outcome 11-item (FLO-11) Questionnaire and Facial Lines Satisfaction Questionnaire (FLSQ). Physicians and subjects assessed GL severity at maximum frown and at rest using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A). RESULTS: Mean total FLO-11 scores increased from 47.7 (baseline) to 75.9 (day 120) (p < 0.0001), with mean improvement of at least two grades for most items maintained to day 120. Most subjects were mostly or very satisfied, per the FLSQ. Percentages of subjects with at least one-grade improvement in FWS-A (responders) at maximum frown per subjects and physicians were 93.1% and 97.1%, respectively, at day 30, and 72.3% and 81.5% at day 120 (all, p < 0.0001). More than 70% were FWS-A responders at day 120. All adverse events were mild or moderate; none were related to onabotulinumtoxinA. CONCLUSIONS: A single onabotulinumtoxinA (20 U) treatment following laser therapy was safe and effective in correcting GL for up to 120 days.

A Prospective, Open-Label Study of Hyaluronic Acid-Based Filler With Lidocaine (VYC-15L) Treatment for the Correction of Infraorbital Skin Depressions.

BACKGROUND: Infraorbital skin depressions are one of the most troublesome facial areas for aesthetically aware patients. OBJECTIVE: Evaluate effectiveness and safety of Juvéderm Volbella with Lidocaine (VYC-15L; Allergan plc, Dublin, Ireland) for correction of bilateral infraorbital depressions. METHODS: In this 12-month, prospective, uncontrolled, open-label study, subjects aged ≥18 years with infraorbital depressions rated ≥1 on the Allergan Infra-oRbital Scale (AIRS) received injections of VYC-15L with optional touch-up treatment on Day 14. The primary efficacy measure was ≥1 AIRS grade improvement from baseline at month 1. RESULTS: Of 80 subjects initially treated with VYC-15L, 75 (94%) completed the study. All injections were intentionally deep, most using multiple microbolus technique. At 1 month, 99.3% of eyes achieved ≥1 AIRS grade improvement. The responder rate (subjects with ≥1 AIRS grade improvement in both eyes) was 99% at month 1, 92% at month 6, and 54% at month 12. Most injection site reactions (e.g., bruising, redness, irregularities/bumps) were mild and resolved by day 14. Late-onset mild to moderate edema was observed in 11% of eyes at month 6% and 4% of eyes at month 12. CONCLUSION: VYC-15L is effective and safe for the treatment of infraorbital depressions, with effectiveness lasting up to 12 months.

Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study.

BACKGROUND: There is increasing interest among patients and plastic surgeons for alternatives to rhinoplasty, a common surgical procedure performed in Asia. OBJECTIVES: To evaluate the safety, efficacy, and longevity of a hyaluronic acid filler in the correction of aesthetically detracting or deficient features of the Asian nose. METHODS: Twenty-nine carefully screened Asian patients had their noses corrected with the study filler (Juvéderm VOLUMA [Allergan plc, Dublin, Ireland] with lidocaine injectable gel), reflecting individualized treatment goals and utilizing a standardized injection procedure, and were followed for over 12 months. RESULTS: A clinically meaningful correction (≥1 grade improvement on the Assessment of Aesthetic Improvement Scale) was achieved in 27 (93.1%) patients at the first follow-up visit. This was maintained in 28 (96.6%) patients at the final visit, based on the independent assessments of a central non-injecting physician and the patients. At this final visit, 23 (79.3%) patients were satisfied or very satisfied with the study filler and 25 (86.2%) would recommend it to others. In this small series of patients, there were no serious adverse events (AEs), with all treatment-related AEs being mild to moderate, transient injection site reactions, unrelated to the study filler. CONCLUSIONS: Using specific eligibility criteria, individualized treatment goals, and a standardized injection procedure, the study filler corrected aesthetically detracting or deficient features of the Asian nose, with the therapeutic effects lasting for over 12 months, consistent with a high degree of patient satisfaction. This study supports the safety and efficacy of this HA filler for specific nose augmentation procedures in selected Asian patients. LEVEL OF EVIDENCE 3: Therapeutic.