Alexander Rivkin

12‐Month Controlled Study in the United States of the Safety and Efficacy of a Permanent 2.5% Polyacrylamide Hydrogel Soft‐Tissue Filler

OBJECTIVE To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds. METHODS AND MATERIALS The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double‐blind, randomized, multicenter, noninferiority trial with a 12‐month follow‐up. The primary efficacy end point was mean change in Wrinkle Assessment Scale (WAS) scores at 6 months. The primary safety end point was rate of serious adverse events (AEs) through 12 months after treatment. RESULTS Polyacrylamide hydrogel was as effective as NASHA, and effectiveness persisted throughout the 12‐month follow‐up. Treatment‐related AEs occurred with equal incidence; most were mild to moderate, transient, and related to injection procedure. One serious AE (infection) was thought to be related to treatment with polyacrylamide hydrogel; it resolved within 5 days after appropriate treatment. CONCLUSION This 2.5% polyacrylamide hydrogel offers promise as a long‐lasting soft tissue filler. It is well tolerated, as effective as NASHA in correction of nasolabial folds, and persistent. Longer evaluation is required to evaluate longer‐term safety and demonstrate duration of effect beyond 12 months. This study was supported by Contura, Soeborg, Denmark. Joan C. Spivak was paid by the sponsor for her editorial assistance.

A Prospective Study of Non-Surgical Primary Rhinoplasty Using a Polymethylmethacrylate Injectable Implant

BACKGROUND Nonsurgical rhinoplasty involves the use of injectable fillers to improve the contours of the nose. It has become a widely practiced procedure since this author first popularized it in 2003. The use of permanent fillers in nonsurgical rhinoplasty has not been well documented, especially in this country. OBJECTIVES To demonstrate the safety and effectiveness of a polymethylmethacrylate (PMMA)‐based filler for nonsurgical rhinoplasty. METHODS and MATERIALS Eligible subjects underwent up to three injection sessions with a commercially available PMMA product and were followed for 1 year. Efficacy was assessed according to evaluator grading of subjects and digital image analysis of standardized photographs. RESULTS Nineteen subjects were enrolled and followed to conclusion. Average improvement in global score was more than one point observed on day 90 and lasting through 1 year. Eight of 10 subjects showed improvement according to digital image analysis at 1 year. Subject satisfaction was high throughout the study. Adverse events were minimal and well tolerated. CONCLUSION Filler rhinoplasty using a PMMA‐based injectable filler is safe and effective. This is the first study documenting the use of PMMA for this indication. Longer‐term follow‐up is needed to demonstrate persistence of improvement.

Long-term effects of onabotulinumtoxinA on facial lines: a 19-year experience of identical twins.

Hyperfunctional lines in the skin are produced by repeated contraction of the underlying muscles. By inhibiting the release of acetylcholine from the presynaptic terminal of the neuromuscular junction, BoNTA inhibits the contraction of muscles, and as such, may serve to prevent or limit the formation of new wrinkles. To date, however, there have been no prospective studies conducted on wrinkle prevention with repeated use of BoNTA. Binder published a unique case report of twins, one regularly treated with onabotulinumtoxinA, whereas the other twin had only had 2 treatments over the course of 13 years. In Binder’s report, photographic documentation showed that the treated twin did not exhibit forehead or glabellar lines at rest, whereas mild resting lines were evident in the sporadically treated twin. This article is a 6-year follow-up of the same twins, as in Dr. Binder’s case study. This case report describes the effects of long-term repeated treatment with onabotulinumtoxinA over a 19-year period. The authors provide a photographic evaluation to assess whether repeated treatments of onabotulinumtoxinA may prevent the formation of hyperfunctional wrinkles or delay the onset of atrophic rhytides that may become permanent.

Volume correction in the aging hand: role of dermal fillers

The hands, just like the face, are highly visible parts of the body. They age at a similar rate and demonstrate comparable changes with time, sun damage, and smoking. Loss of volume in the hands exposes underlying tendons, veins, and bony prominences. Rejuvenation of the hands with dermal fillers is a procedure with high patient satisfaction and relatively low risk for complications. This study will review relevant anatomy, injection technique, clinical safety, and efficacy of dermal filler volumization of the aging hand.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study

Background Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. Objectives Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. Methods Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crows feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. Results Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. Conclusions Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance. Level of Evidence 4

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study

Background VYC-15L (Juvéderm Volbella XC) is a non-animal crosslinked hyaluronic acid (HA) gel with lidocaine. Objective To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. Methods In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. Results LFS responder rates were 86.2%, 80.3%, and 61.8% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touchup treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. Conclusion Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.

Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study

Background The impact of facial aesthetic treatments not only enhances physical appearance, but also psychological well-being. Accordingly, patient-reported outcomes (PROs) are increasingly utilized as an important measure of treatment success. Observer-reported outcomes (OROs) are a relevant yet often-overlooked measure of treatment benefit. Objectives The current study aimed to evaluate the impact of panfacial aesthetic treatment on the perception of an individual in a variety of social contexts. Methods 2000 men and women (aged 18-65 years) participated in an online study designed to capture the blinded observers social perception of pretreatment and posttreatment subjects who received panfacial aesthetic treatment in the HARMONY study. Perceptions relevant to character traits, age, attractiveness, and social status were evaluated. Observers were divided into 2 groups. Single Image Respondents (n=1500) viewed 6 single randomized subject images (3 pretreatment, 3 posttreatment) and Paired Image Respondents (n=500) viewed 6 pretreatment and posttreatment image pairs. Results Single Image Respondents reported significantly (P <0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status. Paired Image Respondents also reported a higher level of agreement posttreatment images were more aligned with positive character traits, younger and more attractive, and of a higher social status. Conclusions The results suggest that the positive impact of minimally-invasive panfacial treatment extends beyond enhancing the physical appearance and highlights the importance of social perception and OROs in aesthetic medicine.