Higher Responder Rates Observed With Live Participant Assessment Versus Photographic Assessment After VYC-20L Hyaluronic Acid Treatment for Chin Augmentation.

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.

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements.

BACKGROUND: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality. OBJECTIVE: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration. METHODS: Participants (≥22 years) with moderate-to-severe investigator-assessed Allergan Cheek Smoothness Scale (ACSS) scores were randomized in 2:1 ratio to receive VYC-12L or control (no treatment with optional treatment). Effectiveness was assessed 1 month after last injection (initial or touch-up) by a responder rate (≥1-grade improvement from baseline on both cheeks) using investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), and tissue dielectric constant probe-measured skin hydration. Safety was evaluated throughout. RESULTS: Participants (VYC-12L, n = 131; control, n = 71) were 86.1% female with a median age of 58.0 years. At month 1, ACSS and AFLS responder rates were statistically significantly higher in the VYC-12L group (57.9%, 58.3%, respectively) than in the untreated controls (4.5%, 5.4%, respectively; p < .001). VYC-12L ACSS and AFLS responder rates remained consistent throughout the 6-month follow-up. Six participants reported treatment-related adverse events; none led to study discontinuation. CONCLUSION: VYC-12L is an effective, well-tolerated treatment for lasting improvement of cheek skin smoothness, fine lines, and hydration.

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.

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

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

Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults.

Background: Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area. Objective: Evaluate the safety and effectiveness of the HA filler Juvéderm® Volbella® (VYC-15L) for lip enhancement in Chinese adults. Methods & Materials: In this multicenter, evaluator-blind study, subjects seeking lip enhancement were randomized 3:1 to VYC-15L or no-treatment control group (with optional treatment delayed by 3 months). Effectiveness endpoints included 1-point improvement on the 5-point Lip Fullness Scale (LFS) assessed by evaluating investigators (EIs) and subjects, and overall volume of lips and change in lip surface area measured from 3-dimensional images. Safety assessments included procedural pain, injection site reactions (ISRs), and adverse events (AEs). Results: The modified intention-to-treat population included 163 subjects (median age, 34 years; 96.9% female). More VYC-15L-treated subjects had a 1-point reduction in EI-reported LFS score at month 3 versus untreated controls (84.7% vs 0%; p < 0.0001), and 65% of the treated subjects self-reported a 1-point LFS improvement at month 3. Procedural pain during injection was mild. The most common ISRs were swelling, tenderness to touch, and firmness. One treatment-related serious AE (injection site compression arterial ischemia) resolved in 16 days. Conclusion: VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects. Clinical Trial Registration Number: NCT03519204.

Safety and Effectiveness of Hyaluronic Acid Filler, VYC-20L, via Cannula for Cheek Augmentation: A Randomized, Single-Blind, Controlled Study.

BACKGROUND: Using cannulas to deliver facial fillers may reduce adverse events (AEs) compared with needle injection. OBJECTIVE: To evaluate the safety and effectiveness of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) via cannula for midface age-related volume deficit. MATERIALS AND METHODS: This multicenter, evaluator-blind, randomized, within-subject, controlled study enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) scores. VYC-20L was administered in one cheek via cannula (with optional needle use in the zygomaticomalar region) and in the other cheek via needle. The primary effectiveness end point was the mean (95% confidence interval [CI]) paired difference between treatments in MFVDS score change from baseline to Month 1; an upper CI limit of less than 0.5 determined noninferiority. Injection-site responses (ISRs), procedural pain, and AEs were assessed. RESULTS: Of 60 randomized and treated subjects, the mean change in MFVDS score from baseline to Month 1 was -1.8 with cannulas and -1.9 with needles, providing a mean (95% CI) paired difference of 0.1 (-0.05 to 0.25). Most ISRs were mild/moderate and resolved within 2 weeks. Procedural pain was minimal, and no serious AEs were reported. CONCLUSION: VYC-20L for cheek augmentation was safe and effective using a cannula and noninferior to needle injection.

A Prospective, Multicenter, Single-Blind, Randomized, Controlled Study of VYC-15L, a Hyaluronic Acid Filler, in Adults for Correction of Infraorbital Hollowing.

BACKGROUND: Rejuvenation of the under-eye area is a popular facial aesthetic treatment option. OBJECTIVES: This study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing. METHODS: This was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥1-grade improvement at Month 3 assessed by an evaluating investigator employing the Allergan Infraorbital Hollow Scale. Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study. RESULTS: At Month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI = 52.9 to 82.0, P < 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were ≤1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in ≤1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in ≤2 weeks. Three participants had swelling/edema starting >30 days posttreatment; 2 resolved in ≤4 days, 1 by 45 days. No treatment-related serious AEs were reported. CONCLUSIONS: VYC-15L was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year.

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

BACKGROUND: VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume. OBJECTIVE: Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion. MATERIALS AND METHODS: Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs). RESULTS: VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae. CONCLUSION: VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.

Safe, Effective Chin and Jaw Restoration With VYC-25L Hyaluronic Acid Injectable Gel.

BACKGROUND: VYC-25L, a hyaluronic acid soft-tissue filler with lidocaine, is designed to restore and create facial volume in the chin and jaw. OBJECTIVE: To evaluate the safety and effectiveness of VYC-25L in subjects with chin retrusion. METHODS: Adults with chin retrusion (145°-165° glabella-subnasale-pogonion facial angle) were randomized (3:1) to receive VYC-25L in the chin/jaw at study onset (treatment group) or 3 months later (control group). Primary effectiveness end point was mean change in facial angle from baseline at Month 3. Safety assessments included injection site responses (ISRs), recorded in a subject diary, and adverse events (AEs). RESULTS: VYC-25L was administered to 119 subjects (treatment group: n = 90; control group: n = 29). Mean change in facial angle from baseline at Month 3 was significantly greater in the treatment versus control group (difference: 2.51°; p < .0001). Effectiveness was also demonstrated by the proportion of subjects with improved/much improved Global Aesthetic Improvement Scale scores and responses on FACE-Q Satisfaction and Psychological Well-Being Scales. Treatment benefit remained evident at Month 12. Common ISRs were firmness (95.8%), tenderness (95.8%), and swelling (91.6%). No serious treatment-related AEs were reported. CONCLUSION: VYC-25L significantly improved glabella-subnasale-pogonion facial angle and was generally safe and well tolerated.

DeoxyArbutin and its derivatives inhibit tyrosinase activity and melanin synthesis without inducing reactive oxygen species or apoptosis.

Safety is a major concern in developing commercial skin-lightening agents. Here, we report the modulating effects of deoxyArbutin (dA) and its second-generation derivatives - deoxyFuran (dF), 2-fluorodeoxyArbutin (fdA), and thiodeoxyArbutin (tdA) - on tyrosinase, and consequently, on melanization. Results demonstrate that dA and its derivatives inhibit tyrosine hydroxylase and dopa oxidase activity of tyrosinase. The inhibition is dose-dependent, thereby inhibiting melanin synthesis in intact melanocytes, when used at concentrations that retain 95% viability of the treated cells in culture. Herein we demonstrate that dA, and its second-generation derivatives dF, fdA, and tdA, exhibit dose-dependent reductions in melanocyte cell number, primarily due to inhibition of proliferation rather than initiation of apoptosis as exemplified by hydroquinone (HQ), ie, cytostatic as opposed to cytotoxic. Human and murine melanocytes with functional mutations in either tyrosinase or tyrosinase-related protein 1 (Tyrp1) are less sensitive to the cytostatic effects of dA and its derivatives. Minimal amounts of reactive oxygen species (ROS) were generated upon treatment with dA and its derivatives, in contrast to a dramatic amount of ROS induced by HQ. This increase in ROS subsequently induced the expression of the endogenous antioxidant catalase in treated melanocytes. Treatment with exogenous antioxidants provided protection for melanocytes treated with HQ, but not dA and its derivatives, suggesting that HQ exerts more oxidative stress. These studies demonstrate that dA and its derivatives are relatively safe tyrosinase inhibitors for skin lightening or for ameliorating hyperpigmented lesions.