Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects.

PURPOSE: Hyaluronic acid injectable gels are commonly used to treat nasolabial folds (NLFs). We evaluated the safety and effectiveness of VYC-17.5L for correcting NLFs in Chinese subjects. PATIENTS AND METHODS: This prospective, multicenter, double-blind, within-subject‒controlled study randomized adults with moderate-to-severe NLFs to VYC-17.5L treatment (initial and touch-up) in 1 NLF and control (without lidocaine) in the contralateral NLF. Effectiveness endpoints at 6 months included noninferiority of VYC-17.5L to control in NLF Severity Scale response rate (primary endpoint), subject-reported procedural pain (11-point scale), and investigator and subject assessments using the Global Aesthetic Improvement Scale (GAIS). RESULTS: A total of 175 subjects were included. The primary endpoint was met, with response rates of 84.2% for VYC-17.5L and 82.5% for control. Mean pain scores after initial and touch-up treatments were 2.4 for VYC-17.5L versus 5.2 for control (P < 0.001) and 2.0 versus 3.3 (P < 0.001), respectively. Investigator-rated GAIS scores were 86.5% for VYC-17.5L versus 86.0% for control. There were no between-group differences in subject-rated GAIS scores. Safety profiles were comparable for VYC-17.5L and control. CONCLUSION: VYC-17.5L was noninferior to control without lidocaine for correcting moderate-to-severe NLFs in Chinese subjects and was superior to control in reducing procedural pain.

Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds.

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. OBJECTIVES: The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment. METHODS: In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale). RESULTS: Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate. CONCLUSIONS: Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.

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.

Intraspinal microstimulation using cylindrical multielectrodes.

A cylindrical multielectrode system specifically designed for intraspinal microstimulation was mechanically and electrically evaluated in the ventral horn of the feline lumbo-sacral spinal cord. Electrode insertions proved to be straight as evaluated from radiographs. Impedances were measured in situ and force recruitment curves from quadriceps muscles were collected over a wide range of stimulus parameters. For a given charge, higher current amplitudes produced greater forces than proportionally longer pulse durations, indicating that charge is not the sole indicator of evoked force in applications utilizing electrical stimulation. Overlap measurements for calculating current-distance constants were collected at a variety of current amplitudes, electrode pair separations, and pair orientations in the spinal grey matter. Forces obtained in the majority of these trials demonstrated an order effect, presumably due to asymmetric neuronal connectivity within the spinal cord. In the cases showing no order effect, the dorso-ventral electrode pair orientation yielded a higher average current-distance constant (278 microA/mm2) than either the medio-lateral or rostro-caudal electrode pair orientations (197 microA/mm2). Specifications of an array of cylindrical multielectrodes for use in future intraspinal microstimulation prostheses were updated.

Microfabricated cylindrical multielectrodes for neural stimulation.

The effects of spinal cord injuries are likely to be ameliorated with the help of functional electrical stimulation of the spinal cord, a technique that may benefit from a new style of electrode: the cylindrical multielectrode. This paper describes the specifications for, fabrication techniques for, and in vitro evaluation of cylindrical multielectrodes. Four tip shapes were tested to determine which shape required the lowest peak force and would, therefore, be expected to minimize dimpling during implantation. The impedance of the electrode interface was monitored for changes due to insertion as well as repetitive delivery of current pulses. The charge delivery capacity was determined by testing with safe (< or = 0.6 mC/cm2) and damaging levels (> or = 0.8 mC/cm2) of charge density. The results of these tests suggest that this electrode design could be used to stimulate neurons in the ventral horn of the spinal cord.