A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers.

Purpose: Age-related changes in skin structure and function can negatively impact skin quality. VYC-12L is a crosslinked hyaluronic acid filler for treating fine lines and improving hydration and elasticity. The goal of this study was to understand skin quality, histologic, and genomic changes underlying long-term clinical benefits of VYC-12L treatment. Patients and Methods: In this prospective, nonrandomized, open-label study, 11 healthy men (n = 2) and women (n = 9) received intradermal VYC-12L treatment on the volar forearm. Clinical probes assessed skin quality at baseline and months 1 and 3 post-treatment. Punch biopsies were collected 1 and 3 months post-treatment to evaluate histologic and genomic changes. Safety was evaluated throughout. Results: Participants had a mean age of 41 years and Fitzpatrick skin phototypes II (54.5%) and III (45.5%). At months 1 and 3, VYC-12L-treated skin had higher hydration in the stratum corneum than untreated skin. Cutometer measurements indicated treated skin that was firmer and more resistant to deformation. Histology showed increased epidermal AQP3 and Ki67 expression 1 and 3 months post-treatment and a qualitative increase in papillary dermal collagen I at month 3. Genomic analyses demonstrated treatment-related upregulation of genes involved in adipocyte differentiation, lipid metabolism, keratinocyte renewal, and dermal extracellular matrix (ECM) maintenance. Injection site reactions were mild-to-moderate in severity and resolved by month 1. Five participants reported 19 adverse events; most (68.4%) were related to the biopsy and none to VYC-12L. Conclusion: VYC-12L produced changes in hydration, firmness, and ECM density and composition consistent with improved skin properties, demonstrating that VYC-12L can act as a substrate for tissue repair.

Efficacy, Patient-Reported Outcomes, and Safety for Millennial Subjects Treated With OnabotulinumtoxinA for Moderate to Severe Horizontal Forehead Lines.

BACKGROUND: Millennials (aged 18-34 years) represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes (PROs), and safety for millennials versus subjects aged at least 35 years after onabotulinumtoxinA treatment of forehead lines (FHL) across 2 phase 3 studies. METHODS: Eligible subjects with moderate to severe FHL received onabotulinumtoxinA (FHL: 20 U; glabellar lines: 20 U, with/without 24 U in crow's feet line regions) or placebo. All findings were pooled by the age group. RESULTS: Millennials composed 15% of subjects (176/1,178). Day 30 responder rates of at least 1-grade Facial Wrinkle Scale improvement in FHL severity for millennials versus subjects aged 35 years and older were 100% versus 97.8% at maximum eyebrow elevation and 78.4% versus 83.5% at rest, respectively. Responder rates were significantly greater with onabotulinumtoxinA than placebo (p ≤ .015) for both groups through Day 180. Similar trends were observed for achieving none/mild severity. Both age groups reported high satisfaction rates and improved psychological impacts with onabotulinumtoxinA treatment. No new safety signals were detected. CONCLUSION: OnabotulinumtoxinA treatment was well tolerated, and both age groups experienced significant improvements in FHL severity, high satisfaction, and improved psychological impacts after treatment. Millennials reported numerically greater improvements.

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.

Creation and Validation of a Photonumeric Scale to Assess Volume Deficiency in the Infraorbital Region.

BACKGROUND: The eyes are particularly important aesthetic features of the face and revitalization of the infraorbital region has become a focus of aesthetic treatments. Published infraorbital scales to date have limitations in that they have been descriptive, subjective, or have used computer-generated images. Thus, there is an unmet need for a validated scale based on actual images. OBJECTIVE: To develop a practical photonumeric scale that respects the complex anatomy and age-related changes occurring in the orbital area. METHODS AND MATERIALS: The Allergan Infra-oRbital Scale (AIRS) was developed through a multistep process in collaboration with 16 physicians (plastic surgeons, dermatologists, and aesthetic physicians). Scale development involved both online photographs and live assessments of subjects. Interrater and intrarater reliability was assessed using intraclass correlation coefficients (ICCs). RESULTS: The final AIRS showed intrarater and interrater ICCs of 0.78 to 0.86 and 0.91 to 0.98 for live validation and 0.76 to 0.82 and 0.86 to 0.91 for online validation, respectively, demonstrating robust validity. CONCLUSION: The AIRS can be considered a photonumeric scale that accurately describes volume loss in the infraorbital region. It has been validated and is appropriate for use in research or for everyday clinical use for both live and photographic assessment.

Ultrasound and Histologic Examination after Subcutaneous Injection of Two Volumizing Hyaluronic Acid Fillers: A Preliminary Study.

BACKGROUND: This study examined the influence of hyaluronic acid (HA) crosslinking technology on the ultrasound and histologic behavior of HA fillers designed for subcutaneous injection. METHODS: One subject received subcutaneous injections of 0.25 ml Cohesive Polydensified Matrix (CPM) and Vycross volumizing HA in tissue scheduled for abdominoplasty by bolus and retrograde fanning techniques. Ultrasound analyses were performed on days 0 and 8 and histologic analyses on days 0 and 21 after injection. A series of simple rheologic tests was also performed. RESULTS: Day 0 ultrasound images after bolus injection showed CPM and Vycross as hypoechogenic papules in the hypodermis. CPM appeared little changed after gentle massage, whereas Vycross appeared more hyperechogenic and diminished in size. Ultrasound images at day 8 were similar. On day 0, both gels appeared less hypoechogenic after retrograde fanning than after bolus injection. Vycross was interspersed with hyperechogenic areas (fibrous septa from the fat network structure) and unlike CPM became almost completely invisible after gentle massage. On day 8, CPM appeared as a hypoechogenic pool and Vycross as a long, thin rod. Day 0 histologic findings confirmed ultrasound results. Day 21 CPM histologic findings showed a discrete inflammatory reaction along the injection row after retrograde fanning. Vycross had a more pronounced inflammatory reaction, particularly after retrograde fanning, with macrophages and giant cells surrounding the implant. Rheologic tests showed CPM to have greater cohesivity and resistance to traction forces than Vycross. CONCLUSIONS: CPM HA volumizer appears to maintain greater tissue integrity than Vycross after subcutaneous injection with less inflammatory activity.