Susan H. Weinkle

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.

Introduction  Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm® injectable gel with lidocaine (denoted as JUV + L) to commercially‐available Juvéderm® injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction.

The third dimension in facial rejuvenation: a review

Background  Facial rejuvenation has long been dominated by surgical techniques that act on only two dimensions of the face, ignoring the third dimension (facial volume); therefore, a truly youthful look remains elusive.

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: Lasers, energy devices, and injectable neurotoxins and fillers

IMPORTANCE Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. OBJECTIVE To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. DESIGN, SETTING, AND PARTICIPANTS A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. EXPOSURES Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. MAIN OUTCOMES AND MEASURES The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. RESULTS Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. CONCLUSIONS AND RELEVANCE Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Anatomical Basis for Safe and Effective Volumization of the Temple.

BACKGROUND One of the earliest but often unaddressed signs of facial aging is volume loss in the temple. Treatment of the area can produce satisfying results for both patient and practitioner. OBJECTIVE Safe injection requires explicit knowledge of the anatomy to avoid complications related to the multitude of vessels that course throughout the region at various depths. The authors aim to detail the anatomy of the area and provide a safe and easy-to-follow method for injection. MATERIALS AND METHODS The authors review the relevant anatomy of the temporal region and its application to cosmetic filler injections. RESULTS The authors describe an easy-to-follow approach for a safe and effective injection window based on numerous anatomical studies. Injection in this area is not without risk, including potential blindness. The authors review the potential complications and their treatments. CONCLUSION Hollowing of the temple is an early sign of aging that, when corrected, can lead to significant patient and practitioner satisfaction. Proper anatomically knowledge is required to avoid potentially severe complications. In this study, the authors present a reliable technique to safely and effectively augment this often undertreated area of the aging face.

Retraction of the Plunger on a Syringe of Hyaluronic Acid Before Injection: Are We Safe?

BACKGROUND Controversy exists concerning the need for aspiration before injection with hyaluronic acid (HA) fillers. OBJECTIVE The authors undertook a study of HA products to determine if blood could be aspirated back into a syringe of HA when the needle has been primed or filled with HA. METHODS AND MATERIALS Two studies were set up to determine if or when blood could be withdrawn from a heparinized fresh tube of blood into the HA syringe. Two different techniques were tested; one using a slow-pull retraction of the plunger and up to a 5-second waiting time before release versus a rapid pullback and quick release. RESULTS Review of these data demonstrates that the usual clinical method, which involves quick withdrawal and instant release of the syringe plunger does not allow for sufficient removal of the filler found intraluminal in the needle and may give rise to false negative results in vitro and likely in vivo with the exception being the Galderma/Medicis products. CONCLUSION In summary, withdrawal of the syringe plunger with no visible blood in the syringe does not eliminate the possibility of intravascular placement of the syringe needle.

Efficacy and Tolerability of Admixing 0.3% Lidocaine with Dermicol‐P35 27G for the Treatment of Nasolabial Folds

BACKGROUND Dermicol‐P35 27G, an advanced collagen dermal filler, is effective for nasolabial fold (NLF) correction. OBJECTIVES To compare the efficacy and tolerance of Dermicol‐P35 27G premixed with lidocaine with that of Dermicol‐P35 27G injected after topical anesthesia for NLF correction. MATERIALS AND METHODS In a split‐face protocol, 10 patients were injected with Dermicol‐P35 27G/topical anesthesia or Dermicol‐P35 27G/0.3% lidocaine. Patients were monitored for adverse events and for pain using the Thermometer Pain Scale (TPS) and a visual analog scale (VAS). Efficacy was measured using the Modified Fitzpatrick Wrinkle Scale and the Global Aesthetic Improvement Scale. RESULTS Patients experienced significantly less pain with Dermicol‐P35 27G/0.3% lidocaine than with Dermicol‐P35 27G/topical anesthesia (mean clinician‐assessed TPS scores ± standard deviation: 2.0 ± 0.8 and 5.2 ± 2.1, respectively, p<.001). Patients reported less discomfort with Dermicol‐P35 27G/0.3% lidocaine than with Dermicol‐P35 27G/topical anesthesia (mean VAS scores: 2.0 ± 1.0 and 6.3 ± 2.0, respectively, p<.001; TPS scores: 2.3 ± 0.6 and 5.4 ± 1.2, respectively, p<.001). Both treatments yielded similar efficacy scores and were well tolerated. Adverse events were mild. CONCLUSION Dermicol‐P35 27G/0.3% lidocaine resulted in less pain than Dermicol‐P35 27G/topical anesthesia, with no observed reduction in efficacy. Funding for this study was provided by ColBar Life Science. Preparation of this manuscript was funded by OrthoDermatologics, Inc.

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.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones

BACKGROUND The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of “milestones,” standard levels of achievement keyed to particular time points, to assess trainee performance during residency. OBJECTIVE To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. METHODS An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. RESULTS Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. CONCLUSION Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.