Aesthetic Office Disaster Preparedness and Response Plan.

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.

A Randomized, Blinded, Prospective Clinical Study Comparing Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers for the Treatment of Perioral Rhytids.

BACKGROUND: Perioral rhytids are a bothersome sign of aging for many patients. Although multiple treatments exist, choosing an optimal modality may be difficult considering that rhytids in this region are fine and the anatomy dynamic. OBJECTIVES: The authors sought to compare the efficacy and safety as well as patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance) in reducing superficial perioral rhytids. METHODS: The study was double-blinded, and 48 patients with moderate to severe superficial perioral rhytids were enrolled. Patients were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right or vice versa. Rhytid severity was measured by patients utilizing a linear analog scale, and by investigators utilizing a validated 5-point scale, for 180 days following treatment. RESULTS: Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL than CPM-HA and remained so at 180 days (P < .05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, and SP-HAL was associated with 1 postinflammatory nodule and 2 occurrences of Tyndall effect. CONCLUSIONS: Although both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect.

A Double-Blind, Randomized Clinical Trial to Determine Effects of Increasing Doses and Dose-Response Relationship of IncobotulinumtoxinA in the Treatment of Glabellar Rhytids.

BACKGROUND: IncobotulinumtoxinA is an effective neuromodulator for treating glabellar rhytids. The relationship between dose and reduction in rhytid severity is well established. However, the effects of escalating doses on the treatment duration response are less understood. OBJECTIVES: The aim of this study was to assess the effects of increasing doses of incobotulinumtoxinA on the treatment duration for glabellar rhytids. METHODS: A randomized, double-blind, Phase IV study was conducted at a fully accredited, outpatient surgical facility. Subjects (31 female, 7 male) with moderate to severe glabellar rhytids were randomized to 1 of 3 incobotulinumtoxinA dose groups: 20, 60, or 100 U. Effect duration was determined by calculating the time to return to baseline for dynamic glabellar lines during maximal contraction. Follow-up was completed through 1 year, and adverse events were monitored. RESULTS: The median duration of effect was 120 days (95% confidence interval [CI] [90, 180 days]), 180 days (95% CI [180, 210 days]), and 270 days (95% CI [240, 330 days]) for the 20-, 60-, and 100-U groups, respectively. A Wald chi-square test from the Cox regression on the primary efficacy variable indicated a statistically significant effect of dose group on time to baseline (chi square = 54.63; df = 2; P < 0.001). Hazard ratios were HR = 0.21 (95% CI [0.10; 0.43] for the 60-U vs the 20-U group, and HR = 0.06 (95% CI [0.10; 0.43]) for the 100-U vs the 20-U group, indicating a statistically longer return to baseline for both the 60- and 100-U cohorts. CONCLUSIONS: There is a dose-dependent relationship between incobotulinumtoxinA and duration of effect in the glabella.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

CME/CE: ABOUT FACE: Navigating Neuromodulators and Injection Techniques for Optimal Results.

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product’s unique properties and dosing, along with an understanding of the patient’s goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice.J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.

ABOUT FACE: Navigating Neuromodulators and Injection Techniques for Optimal Results

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product's unique properties and dosing, along with an understanding of the patient's goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice. J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.

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.

Nerve Blocks Prior to Microfocused Ultrasound Treatment are Safe and Reduce Patient Discomfort.

BACKGROUND: Microfocused ultrasound with visualization has become one of the more popular nonsurgical facial rejuvenation therapies available. Although the treatment has gained wide acceptance, providing adequate pain relief during the procedure can be challenging. OBJECTIVES: The aim of this study was to test our hypothesis that nerve blocks prior to treatment would be well tolerated and significantly reduce patient discomfort. METHODS: Subjects undergoing microfocused ultrasound were offered the choice of participating in a split face nerve block, bilateral block, or a control group. Nerves targeted included infraorbital, supratrochlear, supraorbital, zygomaticofrontal, mental, great auricular, and cervical plexus. Pain assessment was based on a 10-point Wong-Backer FACES Pain score. RESULTS: A total of 65 patients were included in the study: 28 in the split face group, 19 in the bilateral block group, and 18 without a block. The mean [standard deviation] pain score of the bilateral block cohort was 3.9 [1.2], and that of the control group was 5.1 [1.7] (P = 0.001). Patients in the split face cohort reported a higher pain score on the unblocked side of the face (7.5 [1.3]) than on the blocked side (2.9 [1.0]) (P < 0.001). The mean pain score for local anesthetic injection was 2.7 and 1.4 for the split face and the bilateral groups, respectively. There were no adverse events. CONCLUSIONS: Nerve blocks are well tolerated and significantly improve patient comfort during microfocused ultrasound treatment without compromising outcomes or increasing adverse events.

Safety and Effectiveness of Microfocused Ultrasound With Visualization for the Correction of Moderate to Severe Atrophic Acne Scars

Objective: To assess the effectiveness of microfocused ultrasound with visualization (MFU-V) for treating moderate to severe atrophic acne scars. Design: Healthy subjects (N=20) seeking correction of moderate to severe atrophic acne scars on the cheeks and/or temples were enrolled. Scars were predominantly rolling- and boxcar-type, affecting an area ≥5.0cm2. Eighteen subjects completed the study. Intervention: The treatment area was marked with 14mm2 and 25mm2 squares and treated with four transducers: 7 MHz (3.0mm focal depth) and 10 MHz (1.5mm focal depth), each in 14mm and 25mm widths. During each session, MFU-V treatment lines were applied 2-3mm apart, within each treatment area, with a maximum length of 25mm. Each square received 30 treatment lines at two transducer depths (60 total lines). Subjects received three total treatments, with 30 days between each session. The primary outcome measure was improvement in baseline appearance of scars at 90 and 180 days after the final treatment. Secondary outcome measures included changes in severity using an Acne Scar Improvement Scale (ASIS) and Global Aesthetic Improvement Scale (GAIS) at 60-, 90-, and 180-days post-treatment, and a satisfaction questionnaire at 90-days post-treatment. Results: Among the 90-day images available for assessments (n=11), 100% were rated as improved by blinded reviewers, and 64% of pre- and post-treatment images were correctly selected. Among 180-day images (n=15), 100% were rated as improved, and 40% of pre- and post-treatment images were correctly selected. Most subjects were determined to have 25-50% improvement in investigator ASIS scores at 60-, 90-, and 180-days post-treatment. All subjects noted some improvement in severity at the 60-day assessment when measured using ASIS. Based on investigator GAIS scores, 100% of subjects were "Improved" or "Much Improved" at 60-, 90-, and 180-days post-treatment. Based on subject GAIS scores, all subjects noted improvement at the 60-day assessment, and 83% and 89% at the 90- and 180-day assessments, respectively. Overall, 17 subjects (94.4%) expressed some degree of satisfaction at 90-days post-treatment. Conclusions: The results of this study demonstrated that MFU-V therapy is beneficial and well tolerated for the treatment of rolling- and boxcar-type acne scars. J Drugs Dermatol. 2019;18(11):1109-1114.

Injectable fillers: review of material and properties.

With an increasing understanding of the aging process and the rapidly growing interest in minimally invasive treatments, injectable facial fillers have changed the perspective for the treatment and rejuvenation of the aging face. Other than autologous fat and certain preformed implants, the collagen family products were the only Food and Drug Administration approved soft tissue fillers. But the overwhelming interest in soft tissue fillers had led to the increase in research and development of other products including bioengineered nonpermanent implants and permanent alloplastic implants. As multiple injectable soft tissue fillers and biostimulators are continuously becoming available, it is important to understand the biophysical properties inherent in each, as these constitute the clinical characteristics of the product. This article will review the materials and properties of the currently available soft tissue fillers: hyaluronic acid, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, and autologous fat (and aspirated tissue including stem cells).

Efficacy and safety of and patient satisfaction with injectable hyaluronic acid with 0.3% lidocaine hydrochloride for the treatment of superficial perioral lines or superficial lateral canthal lines.

BACKGROUND: It is commonly requested that perioral and lateral canthal rhytides, which result from extrinsic and intrinsic factors, be rejuvenated. OBJECTIVE: To valuate the safety and efficacy of and patient satisfaction with injectable hyaluronic acid (HA) with 0.3% lidocaine hydrochloride in reducing superficial, vertical perioral wrinkles and superficial, horizontal, lateral canthal rhytides. MATERIALS AND METHODS: This was a two-center, evaluator-masked, 180-day study in which 40 patients with moderate to severe superficial, vertical perioral lines or superficial, horizontal, lateral canthal lines were treated at their baseline visit with up to three 0.9-mL syringes of HA (5.5 mg/mL) with 0.3% lidocaine hydrochloride. The investigator and a blinded evaluator assessed patients 7 days after treatment and then every 30 days after the initial treatment session for 180 days. RESULTS: Subjects experienced statistically significant improvement in their superficial, vertical perioral lines and superficial, horizontal, lateral canthal lines and maintained those results for 180 and 120 days, respectively. Three patients experienced delayed-onset periocular nodule formation associated with swelling and erythema at sites of injection, which were histologically consistent with a granulomatous reaction to the product. CONCLUSION: Injectable HA with a particle size of 350 µm was efficacious and resulted in high patient improvement scores in improving moderate to severe superficial, vertical perioral lines and superficial, horizontal, lateral canthal lines. Three of the 40 enrolled patients demonstrated granuloma formation.

Pins and needles: minimally invasive office techniques for facial rejuvenation.

The desire for minimally invasive facial rejuvenation has continued to increase from the perspective of both the patients and injectors. For successful rejuvenation, it is important to understand the anatomic changes of the aging face as well as the properties of available neuromodulators and soft tissue fillers. The injector should be knowledgeable of the advantages and disadvantages of each product. Patient selection, perhaps, plays the largest role in success, choosing patients that would truly benefit from and have reasonable expectations for minimally invasive techniques. Unsatisfactory outcomes can be limited by meticulous injection technique and well thought out treatment plans.

Autologous Fat Harvest and Preparation for Optimal Predictable Outcomes.

Best practices in fat transfer to the face focus on tissue harvest and processing techniques. This article discusses the role of adipose-derived mesenchymal stem cells (MSCs) in mitigating tissue loss in grafting. Discrepancies among common practice and recent study results have propagated uncertainty with long-term results. Fortunately, recent increases in the understanding of these MSCs are leading providers to identify statistically more favorable tissue donor sites, harvest technique, and preparation methods to increase their concentration in transferred tissue. Future studies are needed to support or confound the long-term effects of MSC transfer on facial fat grafting.

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

BACKGROUND: The porcine collagen-derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.). METHODS & MATERIALS: Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR. RESULTS: Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced. CONCLUSION: The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non-touch-up subjects.

Determination of shear strength of periosteum attached to bone with BioGlue Surgical Adhesive.

OBJECTIVE: To determine the shear strength of BioGlue Surgical Adhesive (Cryolife Inc, Kennesaw, Georgia) for use in periosteal fixation in endoscopic browplasty. METHODS: In a controlled design, the shear strength of periosteal attachment to native bone and that of dissected periosteum affixed to bone with BioGlue surgical adhesive was physiologically determined. Twenty-one periosteum and bone samples were harvested from 3 human cadavers. These samples were tested for maximum shear strength using an Instron Model 5500 universal materials testing machine. Native samples consisted of periosteum still attached to the bone surface, while BioGlue samples consisted of dissected periosteum reattached to the bone surface using BioGlue surgical adhesive. The maximum shear strength attained for each sample was recorded and used to determine if native samples differed from those using BioGlue surgical adhesive. RESULTS: The mean (SD) maximum shear strength values obtained during testing were 57.8 (31.7) kPa and 45.9 (27.4) kPa (589.4 [323.3] gram force [gf]/cm(2) and 468.0 [279.4] gf/cm(2)) for native (n=8) and BioGlue (n=9) samples, respectively. There was no statistical difference between the native and BioGlue samples (P> .05) using analysis of variance. CONCLUSION: This study demonstrates that the adhesive properties of BioGlue are similar to the strength of attachment of native periosteum to bone and supports the use of BioGlue as an alternative method of fixation for use in endoscopic brow-lifting.

A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds.

BACKGROUND: Non-animal-stabilized hyaluronic acid (NASHA) offers longer-lasting cosmetic improvement and reduced risk of hypersensitivity and requires less injection volume than bovine collagen-derived dermal fillers. Porcine collagen-derived Dermicol-P35 has low immunogenicity and has the potential to provide durability at least equivalent to that of NASHA. OBJECTIVE: The objective was to evaluate the efficacy and safety of Dermicol-P35 and NASHA for correction of nasolabial folds (NLFs). METHODS AND MATERIALS: A total of 149 subjects with moderate NLFs were randomized to receive Dermicol-P35 and NASHA on contralateral sides of the face. If needed, subjects could receive a repeat injection 2 weeks later to obtain an optimal cosmetic result (OCR). RESULTS: Significant (p<.001) improvement in the Modified Fitzpatrick Wrinkle Scale scores relative to screening was observed after treatment with Dermicol-P35 and NASHA. Relative to the OCR visit, mean scores increased (p<.001) over time, but there were no significant differences between treatments (+0.39 and +0.37 at 6 months; p=.626). Greater proportions of subjects experienced swelling, bruising, and pain at the NASHA site. Several subjects had more induration at the Dermicol-P35 site. There was no evidence of any adverse immunologic effect. CONCLUSION: The effectiveness of Dermicol-P35 is maintained for at least 6 months and is equivalent to NASHA for the correction of NLFs.

Botulinum neurotoxins and injectable fillers: minimally invasive management of the aging upper face.

Attitudes on the use of injectable agents for rejuvenation of the face have changed dramatically over the last decade. This is particularly true for the upper third of the face, where the impact of the use of Botox had its first application. In the author's opinion, no technique, device, or pharmaceutical has had a greater impact on the aesthetic surgery than the now widely used botulinum toxin as an injectable agent.

Botulinum toxins for facial wrinkles: beyond glabellar lines.

Botulinum toxin type A (BTX-A) has been used for years with excellent results for upper facial cosmetic applications. Because of this success, the use of BOX-A for facial aesthetics has expanded to the lower facial and neck regions. BTX-A, especially when used in combination with fillers, has generally proven to be safe and efficacious in these areas. For optimal results, however, several issues must be taken into considerations, including dosing differences versus upper facial applications, the specific type of botulinum toxin used and the importance of precise placement and injection technique. In this article, the authors present their experience with BTX-A in the lower face and neck, and compare and contrast their current practices with those reported by others.

Anatomic considerations for treatment with botulinum toxin.

Botulinum toxin A treatment continues to increase in popularity and number. Many more patients are undergoing cosmetic Botox procedures and many, diverse practitioners are providing them. The best results are obtained from a careful history and physical examination of the patient combined with a detailed understanding of facial and neck anatomy. Understanding the dynamic anatomic relationships, such as agonist-antagonist muscles and contraction force vectors, is key to providing the patient with an excellent outcome.