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Background Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited. Objectives The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. Methods Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Results Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. Conclusions The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population. Level of Evidence: 1

The position of the eyebrow is known to reflect emotional status and to provide a plethora of nonverbal information. Although the eyebrow has no direct attachment to underlying bone, it is subject to the interplay between the various periorbital muscles, which when acting together, permit important nonverbal cues to be conveyed. Understanding the balance and interplay between these muscles is of crucial importance when targeting the periorbital area with neuromodulators. The authors' aims were to summarize current anatomic and clinical knowledge so as to provide a foundation that physicians can rely on to improve and increase the predictability of patient outcomes when treating the periorbital region with neuromodulators for aesthetic purposes.This narrative review is based on the anatomic and clinical experience of the authors dissecting and treating the periorbital region with specific focus on the glabella and the forehead.This narrative review covers (1) a brief description of the relevant periorbital muscle anatomy, (2) an analysis of each muscle's contribution to various facial expressions, and (3) an anatomic and physiologic simulation of the muscular effects of specific neuromodulator injection sites.By understanding functional anatomy of the periorbital muscles and combining this knowledge with individualized assessment and treatment planning, it is possible to achieve aesthetically pleasing, predictable, and reproducible treatment outcomes that positively impact perception of nonverbal cues when administering neuromodulators.

Background Injecting soft tissue fillers into the deep plane of the forehead carries the risk of injection-related visual compromise due to the specific course of the arterial vasculature. Objectives The aim of this study was to investigate the 2- and 3-dimensional location of the change of plane of the deep branch of the supratrochlear and supraorbital artery, respectively. Methods A total of 50 patients (11 males and 39 females; mean age, 49.76 [13.8] years, mean body mass index, 22.53 [2.6] kg/m2) were investigated with ultrasound imaging. The total thickness and the distance of the arteries from the skin and bone surface were measured with an 18-MHz broadband compact linear array transducer. Results The deep branch of the supraorbital artery changed plane from deep to superficial to the frontalis muscle at a mean distance of 13 mm (range, 7.0-19.0 mm) in males and at 14 mm (range, 4.0-24.0 mm) in females and for the deep branch of the supratrochlear artery at a mean distance of 14 mm in males and females (range, 10.0-19.0 in males, 4.0-27.0 in females) when measured from the superior orbital rim. Conclusions Based on the ultrasound findings in this study, it seems that the supraperiosteal plane of the upper and lower forehead could be targeted during soft tissue filler injections because the deep branches of both the supraorbital and supratrochlear arteries do not travel within this plane. The superficial plane of the lower forehead, however, should be avoided due to the unpredictability and inconsistent presence of the central and paracentral arteries. Level of Evidence: 4

Background Precise injection technique is vital for avoiding suboptimal eyebrow position when treating glabellar lines with botulinum toxin type A. Objectives The aim of this study was to evaluate the impact of glabellar injection technique on eyebrow position in patients treated with DaxibotulinumtoxinA for Injection (DAXI). Methods This retrospective post hoc analysis involved 60 adults who received a single treatment with DAXI 40 U to the glabella and had standardized facial photography. Median vertical and horizontal displacement of the brows (at rest) at baseline and 2 weeks after glabellar injection were measured. Brow position outcomes were evaluated by an oculoplastic surgeon and expert anatomist. Investigators were interviewed to ascertain individual injection techniques. Results Precise injection location and depth, and median resting brow position following treatment varied between investigators. Positive brow outcomes were achieved with deep DAXI injections into the medial corrugator, superficial lateral corrugator injections placed between the midpupil and lateral limbus, and deep midline procerus injections. Glabellar injection technique that more precisely targeted the corrugator muscles resulted in longer glabellar line treatment duration compared to a less targeted technique. Medial corrugator injections above the medial brow; lateral corrugator injections administered deeply or more medially, toward the medial third of the brow; and procerus injections superior to the inferomedial brow tended to be associated with suboptimal outcomes that were more apparent during dynamic expression. Conclusions Aesthetically pleasing brow outcomes and greater duration of efficacy can be achieved with an injection pattern that precisely treats the anatomic location of the corrugator supercilii and procerus muscles, avoiding the frontalis. Level of Evidence: 4

Background The number of soft-tissue filler injections performed in the United States is constantly increasing and reflects the high demand for enhanced facial and body attractiveness. The objective of the present study was to measure the viscoelastic properties of soft-tissue fillers when subjected to different testing frequencies. The range of tested frequencies represents clinically different facial areas with more [lips (high frequency)] or less [zygomatic arch (low frequency)] soft-tissue movement. Methods A total of 35 randomly selected hyaluronic acid-based dermal filler products were tested in an independent laboratory for their values of G', G″, tan δ, and G* at angular frequencies between 0.1 and 100 radian/second. Results The results of the objective analyses revealed that the viscoelastic properties of all tested products changed between 0.1 and 100 radian/second angular frequency. Changes in G' ranged from 48.5 to 3116 percent, representing an increase in their initial elastic modulus, whereas changes in G″ ranged from -53.3 percent (i.e., decrease in G″) to 7741 percent (i.e., increase in G″), indicating both an increase and a decrease in their fluidity, respectively. Conclusions The increase in G' would indicate the transition from a "softer" to a "harder" filler, and the observed decrease in G″ would indicate an increase in the filler's "fluidity." Changes in the frequency of applied shear forces such as those occurring in the medial versus the lateral face will influence the aesthetic outcome of soft-tissue filler injections.

Despite the perception that treatment of glabellar lines with botulinum toxin A is straightforward, the reality is that the glabellar region contains a number of interrelated muscles. To avoid adverse outcomes, practitioners need to appreciate how treatment of 1 facial muscle group influences the relative dominance of others. In particular, practitioners need to understand the independent role of the frontalis in eyebrow outcomes and the potential for negative outcomes if the lower frontalis is unintentionally weakened by botulinum toxin A treatment. In addition, practitioners must recognize how inter-individual variation in the depth, shape, and muscle fiber orientation among the upper facial muscles can affect outcomes. For optimal results, treatment of the glabellar complex requires a systematic and individualized approach based on anatomical principles of opposing muscle actions rather than a one-size-fits-all approach. This review provides the anatomical justification for the importance of an integrated assessment of the upper facial muscles and eyebrow position prior to glabellar treatment. In addition, a systematic and broad evaluation system is provided that can be employed by practitioners to more comprehensively assess the glabellar region in order to optimize outcomes and avoid negatively impacting resting brow position and dynamic brow movement.Level of Evidence: 5

Background The injection of hyaluronic acid (HA) dermal fillers is a popular minimally invasive approach to improve lip volume and contour, and with improved techniques has gained popularity because full lips are often associated with beauty and youth. Patient satisfaction is a key driver for successful aesthetic procedures, influencing individual treatment plans and future recommendations. Objective To evaluate subject and partner satisfaction with the hyaluronic acid (HA) dermal filler HARK for lip enhancement at 8 weeks after the last treatment. Methods & materials Subjects in this open-label study all received HARK in the lips, and an additional group also received HARR and/or HARD in nasolabial folds (NLFs) and marionette lines (MLs). Satisfaction was assessed at Weeks 4 and 8 after the last treatment using questionnaires (FACE-Q™ [subjects] and KISSABILITY [subjects and partners]). Results Nineteen subjects received HARK only; 40 also received HARR and/or HARD . Subjects reported a high level of satisfaction with their lips following treatment. Increases from baseline in the mean total satisfaction score were statistically significant at Weeks 4 and 8 (P ≤ .001). Most subjects (≥89%) reported satisfaction on all FACE-Q questions at Week 8. Both subjects and partners were satisfied with the kissability, appearance, and natural look and feel of the post-treatment results. Conclusion This study demonstrated that HARK resulted in lip enhancement with high levels of subject and partner satisfaction, when used alone or in combination with HARR / HARD in NLFs and MLs.

Supplemental Digital Content is Available in the Text., BACKGROUND HARK is an FDA-approved flexible filler designed for lips. OBJECTIVE To quantitatively evaluate subject outcomes by measuring the change in lip texture, color (redness), lip fullness, and lip and perioral surface stretch (dynamic strain) after treatment. METHODS AND MATERIALS In this 8-week open-label, Phase IV multicenter study, subjects were treated with HARK in the lips and HARR and/or HARD in perioral wrinkles and folds as add-on treatment. Assessments included 2D photographic analyses of lip texture and color, and 3D photographic assessments of lip enhancement and dynamic strain. RESULTS HARK significantly improved lip texture (p ≤ .002), lip redness (p < .001), and added fullness to the lips (lip enhancement measurements; p < .001), at Week 8 after treatment. In addition, lower lip wrinkles were significantly reduced (p = .007) and there was a reduction in upper lip wrinkles (not statistically significant). Surface stretch (dynamic strain) in the lip and perioral region was significantly increased after treatment (p < .001). CONCLUSION This analysis provides an objective measure of the beneficial effects of flexible hyaluronic acid fillers in lip augmentation and perioral enhancement and demonstrates a significantly improved lip texture, red color, and fullness. A significant increase in surface stretch (dynamic strain) is indicative of tissue expansion and improvement in lip smoothness.

Background Lips are considered a key element of facial attractiveness due to their central position in the face and their elemental role in verbal and nonverbal communication. Objectives The authors sought to provide clinically relevant information on the 3-dimensional pathway of the superior and inferior labial arteries within the lips to increase safety during labial soft tissue filler injections. Methods The study enrolled 41 healthy volunteers with a mean age of 26.17 ± 9.6 years and a mean body mass index of 23.09 ± 2.3 kg/m2. Ultrasound imaging was performed at 6 different locations. The position of the labial arteries within the lips, depth of the arteries, cranio-caudal location of each artery in relation to the vermilion border, and diameter of the superior/inferior labial arteries were recorded. Results The most frequent location of both the superior and inferior labial arteries was the submucosal plane (58.5%) followed by intramuscular (36.2%) and subcutaneous (5.3%) planes. The depth of the superior labial artery in the upper lip was 5.6 ± 0.13 mm, whereas the depth of the inferior labial artery in the lower lip was 5.2 ± 0.14 mm. Both arteries were more frequently located within the red lip: upper lip (83% vs 18.7%) and lower lip (86.2% vs 13.8%). In the midline, the artery coursed within the red lip in all investigated volunteers. Conclusions Clinically, results of this study favor a superficial injection plane for lip volumization procedures. A perpendicular approach to the lip (coming from the cutaneous lip) might increase safety because the artery is located most frequently within the red lip.

Background Glabellar soft tissue filler injections have been shown to be associated with a high risk of causing injection-related visual compromise. Objectives The aim of this study was to identify the course of the superficial branch of the supratrochlear and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line and to test whether an artery is located deep to this line. Methods Forty-one healthy volunteers with a mean age of 26.17 [9.6] years and a mean BMI of 23.09 [2.3] kg/m2 were analyzed. Ultrasound imaging was applied to measure the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines, and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning. Results The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59 [4.0] mm in males and 8.21 [4.0] mm in females, whereas it was 22.38 [5.5] mm for the supraorbital artery in males and 20.73 [5.6] mm in females. Upon frowning, a medial shift in supratrochlear arterial position of 1.63 mm in males and 1.84 mm in females and of 3.9 mm in supraorbital arterial position for both genders was observed. The mean depth of the supratrochlear artery was 3.34 [0.6] mm at rest, whereas the depth of the supraorbital artery was 3.54 [0.8] mm. Conclusions The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.

Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Background Subjects seeking facial rejuvenation want the results to appear natural. Currently, however, there is no consensus definition of, or assessment scale for, “naturalness.” Aims This open‐label pilot study explored evaluation techniques and criteria to assess naturalness of facial movement and expression following optimal bilateral correction of moderate‐to‐severe nasolabial folds and marionette lines with soft‐tissue hyaluronic acid fillers formulated with XpresHAn Technology™. Methods Primary efficacy was investigator assessed naturalness of dynamic expressions using baseline and Day 42 posttreatment 2D video. Other evaluations included investigator assessed naturalness using static images, wrinkle severity, investigator and subject Global Aesthetic Improvement Scale assessments, and subject satisfaction. Results Thirty Caucasian females (41‐65 years) received either Restylane ® Refyne, Restylane ® Defyne or both. Naturalness of dynamic expressions was at least maintained in all subjects. Naturalness of static expressions was not negatively affected in most subjects (96.7%). For dynamic expressions, 83.3% of subjects showed enhanced attractiveness, younger appearance and maintained naturalness. Conclusions Overall, nasolabial folds and marionette lines improved significantly based on severity and Global Aesthetic Improvement Scale scores, with high subject satisfaction and favorable safety profile. Based on subject satisfaction and investigator assessments, using highly flexible hyaluronic acid dermal fillers did not compromise naturalness of lower facial expressions while achieving the desired improvements in attractiveness and youthfulness. The preliminary results obtained in this pilot study suggest that dynamic and static assessments of facial animation may aid the evaluation of natural outcomes in facial rejuvenation procedures.

Background: Injectable hyaluronic acid fillers are routinely used for correction of soft-tissue volume loss and facial rejuvenation. Product differentiation has primarily been based on the rheologic parameter known as elastic modulus (G′), although other physicochemical properties are being explored to characterize potential product performance. As clinical data regarding product performance are lacking, the practical experience of injectors provides a valuable bridge in the knowledge gap between product rheologic data and product use. Methods: Rheologic and physicochemical measurements (swelling factor and cohesion) were collected for 18 products. To observe the impact of G′ and hyaluronic acid concentration on swelling factor and cohesion, proportional relationships were evaluated. Contributing authors were queried regarding their G′-based selection of products when considering skin quality, degree of correction, injection depth, and anatomical location. Results: Relationships were observable between G′ and swelling factor and G′ and cohesion only when limited to products manufactured by the same crosslinking technology and the same concentration. No relationship between isolated hyaluronic acid concentration and swelling factor or cohesion was apparent. Although rheological parameters and the assumptions of ex vivo data translating to in vivo performance are oftentimes not completely aligned, in the clinical experience of the authors, in general, higher G′ products are better suited for thicker skin and deeper injection planes, whereas lower G′ products are better for more superficial planes, although exceptions to these trends are also made based on technical experience. Conclusions: While rheologic and physicochemical characteristics can vary widely between products and the methods and measurements of these parameters are often difficult to correlate, G′ represents a useful and consistent parameter for product differentiation. Understanding how to select products based on G′ is valuable knowledge for customizing injection plans and contributes to an optimal aesthetic outcome.

Since lips have a significant role in facial aesthetic perception, lip augmentation is an increasingly popular aesthetic procedure.To evaluate aesthetic improvement and facial dynamics with hyaluronic acid (HA) fillers in the lips and perioral region at 8 weeks after the last treatment compared to pre-treatment.In this open-label study, all subjects received HARK in the lips, and an additional group also received HARR and/or HARD in nasolabial folds (NLFs) and marionette lines (MLs). Assessments included aesthetic improvement, naturalness of facial expressions, perception of age, and lip texture.Nineteen subjects received HARK only; 40 received HARK and HARR and/or HARD. The primary objective was met. All subjects experienced aesthetic improvement in lip fullness at week 8. The investigators also reported aesthetic improvement in all subjects. For the majority of subjects, aesthetic improvement was associated with maintenance of natural and youthful facial expressions, and improved lip texture. Most treatment-emergent adverse events were mild; none were serious.HARK is a well-tolerated and effective treatment for enhancing lip fullness, maintaining naturalness and youthfulness of facial expressions, and smoothing lip texture, whether used alone or in combination with HARR/ HARD in the NLFs and/or MLs. J Drugs Dermatol. 20(4): 402-408. doi:10.36849/JDD.2021.5525.

Botulinum toxin A (BTX-A) injections have become the most popular noninvasive cosmetic procedures performed worldwide. With growing interest, investigators continue to uncover an expanding array of aesthetic indications for BTX-A. Botulinum toxin A has been used off-label in the management of masseter hypertrophy for facial slimming, platysmal bands, nasal 'bunny' lines, perioral rhytides, gummy smile and scars, to name a few. Interestingly, the injection of multiple microdroplets of dilute BTX-A into the dermis, sometimes referred to as 'microbotox', has been investigated as a tool for facial rejuvenation. A handful of prospective studies and case series have demonstrated the benefit of BTX-A in the treatment of facial erythema and improving skin texture. The aim of this review is to summarize and appraise currently available data on the role of BTX-A in treating facial erythema and skin quality, with a special focus on potential pathophysiologic mechanisms.

Background: Objective dynamic assessments are central to the evaluation of facial rejuvenation treatments. This study used three-dimensional digital stereophotogrammetry to generate a quantitative dynamic assessment of facial strain and hyaluronic acid filler efficacy. Methods: Thirty women (aged 41 to 65 years) with moderate to severe bilateral nasolabial folds and marionette lines received Restylane Refyne, Restylane Defyne, or both, and were compared to a “younger” untreated group (n = 20; aged 25 to 35 years). Three-dimensional videos were collected at baseline and at day 42. Dynamic strain was analyzed at the marionette lines and nasolabial folds as subjects went from a neutral position through a series of facial expressions. Results: Baseline nasolabial folds and marionette lines showed statistically significant (p ≤ 0.05) differences in the level of stretch between younger and older untreated subjects, with higher stretch profiles observed in the older cohort. In the older cohort, filler treatment reduced peak strain (stretch) in the nasolabial folds and marionette lines compared with baseline across all tested expressions, resembling the youthful strain profile of the younger untreated control group. Treatment was well tolerated. Conclusions: Quantitative dynamic strain analysis is an innovative method for evaluating the dynamic face following dermal fillers and provides objective evidence that such treatment results in stretch levels resembling a younger phenotype in areas prone to the effects of facial aging. The strain reduction following filler treatment objectively conveys a dermal tightening effect, likely secondary to the volumization of treated areas. Additional studies will refine the technology and associated procedures to optimize quantitative dynamic strain analysis for treatment planning and patient outcome optimization. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Background Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002). Objective To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity. Materials and methods In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks. Results Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup. Conclusion 40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.

Background DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA. Objective To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines. Methods Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed ( NCT03014622 and NCT03014635 on www.clinicaltrials.gov ). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks). Results Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated—treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%). Limitations The study population was predominantly female and white and received only a single treatment. Conclusions DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.

As the use of fillers becomes increasingly more common and the skill level of those injecting is so varied, adverse events can be expected to increase as well. Avoiding complications is always the best measure, and with appropriate training and injection techniques, many complications can be avoided. However, adverse events can occur in the best of hands, and early detection and treatment may eliminate or minimize sequelae. This article is an effort to help in that endeavor.

BACKGROUND Measurement scales that quickly and rigorously evaluate the effectiveness of filler treatment in hands are important tools in clinical practice. The Merz Hand Grading Scale (MHGS) is used to grade the appearance of the dorsal hand. The MHGS has been validated for photographic and live assessment of the hands. OBJECTIVE To evaluate the sensitivity of the 5-point MHGS to detect clinically meaningful and aesthetically pleasing changes in hand appearance after treatment with a calcium hydroxylapatite (CaHA)-based dermal filler. METHODS The controlled 4-week study randomized 30 subjects (60 hands) 2:1 to a Treatment group (treatment at enrollment) or a Control group (treatment at end of study). Effectiveness was evaluated with live MHGS ratings and photographic assessments with the Global Aesthetic Improvement Scale (GAIS). RESULTS At Week 4, all Treatment group subjects (20/20) achieved a ≥1-point improvement on the MHGS compared with 0/10 (0%) of the Control group (p < .0001). Subjects and treating physicians rated 92.5% (37/40) and 100% (40/40), respectively, of hands as at least "improved," using the GAIS. CONCLUSION The MHGS is an appropriate and validated tool that clinicians can use to counsel patients and evaluate clinically meaningful and aesthetically pleasing changes after hand treatment with CaHA.

Background Soft-tissue augmentation with hyaluronic acid (HA) fillers has become one of the most popular cosmetic procedures performed. HA fillers represent safe and commonly used fillers. Several different HA fillers are available. The differences lie in the manufacturing process, allowing for tailored uses. A small-particle HA with lidocaine (SP-HAL; Restylane Silk; Galderma, Uppsala, Sweden) was approved by the US Food and Drug Administration in June 2014 but has been available for many years in Canada as Restylane Fine Lines and in Europe as Restylane Vital. Methods Relevant articles were reviewed relating to the composition, effectiveness, and safety of SP-HAL. We also discuss the author's extensive clinical experience in the use of this product in Canada. Results SP-HAL has demonstrated proven benefits for lip fullness, augmentation, and treatment of perioral rhytides. Although off-label in the United States, SP-HAL is also well suited for the treatment of superficial fine lines, including periorbital, forehead, marionette, and smile lines. In addition, it has also been used in the tear trough region. A novel application for SP-HAL includes use as a skinbooster with intradermal micropuncture. In this technique, small aliquots of product are injected so as to gradually rejuvenate the skin in areas such as the face and hands. Side effects of SP-HAL were generally transient and mild. The most common side effects were swelling, tenderness, bruising, pain, and redness. Conclusion SP-HAL is an effective and safe HA filler with varied clinical uses.

Patient satisfaction with treatment is an important outcome in facial aesthetic medicine.To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crow's feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ).In this randomized double-blind study, subjects with moderate/severe GL and CFL received onabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale).Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p.001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p.001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively.High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.

This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL).To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile).This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated.Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p.001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate.Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.

Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy.To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002].In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks.Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups.The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).

Calcium hydroxylapatite microspheres in a carrier gel (CaHA; Radiesse®: Merz North America, Inc., Raleigh, NC) is approved by the United States Food and Drug Administration for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds (NLFs). Lidocaine is often mixed with injectable dermal fillers to reduce injection pain. A new formulation of CaHA has been developed with the convenience of integral 0.3% lidocaine, CaHA (+).br /This multicenter, split-face, double-blind study randomized subjects to receive treatment with CaHA (+) in one NLF and CaHA without lidocaine in the contralateral NLF. The pain level for each NLF was evaluated immediately following the injection using a 10-cm visual analog scale (VAS), and every 15 minutes for 60 minutes plus follow-up visits. Additional endpoints included aesthetic outcomes and subject preference. All subjects (N=102) received treatment.br /CaHA (+) treatment resulted in a statistically and clinically significant reduction in pain ratings immediately after injection compared with CaHA. The mean difference in VAS scores for pain was -4.41 (emP/emlt;0.0001). In 90% of subjects, the VAS scores were ≥2.0 cm lower for the CaHA (+)-treated NLF. A significant reduction in pain ratings throughout the first hour after injection was observed with CaHA (+) compared with CaHA (emP/emlt;0.0001). Both treatment groups achieved significant aesthetic improvement; however, the pain differential resulted in a subject-reported preference for CaHA (+). CaHA (+) with integral lidocaine significantly reduces pain and is as effective as CaHA.br /br /emJ Drugs Dermatol/em. 2016;15(8):1005-1010.

Recent advancements, including more versatile facial fillers, refined injection techniques and the adoption of a global facial approach, have contributed to improved patient outcome and increased patient satisfaction. Nine Canadian specialists (eight dermatologists, one plastic surgeon) collaborated to develop an overview on volume restoration and contouring based on published literature and their collective clinical experience. The specialists concurred that optimal results in volume restoration and contouring depend on correcting deficiencies at various layers of the facial envelope. This includes creating a foundation for deep structural support in the supraperiosteal or submuscular plane; volume repletion of subcutaneous fat compartments; and the reestablishment of dermal and subdermal support to minimize cutaneous rhytids, grooves and furrows. It was also agreed that volume restoration and contouring using a global facial approach is essential to create a natural, youthful appearance in facial aesthetics. A comprehensive non-surgical approach should therefore incorporate combining fillers such as high-viscosity, low-molecular-weight hyaluronic acid (LMWHA) for structural support and hyaluronic acid (HA) for lines, grooves and furrows with neuromodulators, lasers and energy devices.

BACKGROUND Hyperhidrosis can have profound effects on a patient's quality of life. Current treatment guidelines ignore disease severity. OBJECTIVE The objective was to establish clinical guidelines for the recognition, diagnosis, and treatment of primary focal hyperhidrosis. METHODS AND MATERIALS A working group of eight nationally recognized experts was convened to develop the consensus statement using an evidence-based approach. RECOMMENDATIONS An algorithm was designed to consider both disease severity and location. The Hyperhidrosis Disease Severity Scale (HDSS) provides a qualitative measure that allows tailoring of treatment. Mild axillary, palmar, and plantar hyperhidrosis (HDSS score of 2) should initially be treated with topical aluminum chloride (AC). If the patient fails to respond to AC therapy, botulinum toxin A (BTX-A; axillae, palms, soles) and iontophoresis (palms, soles) should be the second-line therapy. In severe cases of axillary, palmar, and plantar hyperhidrosis (HDSS score of 3 or 4), both BTX-A and topical AC are first-line therapy. Iontophoresis is also first-line therapy for palmar and plantar hyperhidrosis. Craniofacial hyperhidrosis should be treated with oral medications, BTX-A, or topical AC as first-line therapy. Local surgery (axillary) and endoscopic thoracic sympathectomy (palms and soles) should only be considered after failure of all other treatment options. CONCLUSIONS These guidelines offer a rapid method to assess disease severity and to treat primary focal hyperhidrosis according to severity.

Background: Human-associated bacterial communities on the skin, skin microbiome, likely play a central role in development of immunity and protection from pathogens. In atopic patients, the skin bacterial diversity is smaller than in healthy subjects. Objective: To review treatment strategies for atopic dermatitis in Canada, taking the skin microbiome concept into account. Methods: An expert panel of 8 Canadian dermatologists explored the role of skin microbiome in clinical dermatology, specifically looking at atopic dermatitis. Results: The panel reached consensus on the following: (1) In atopic patients, the skin microbiome of lesional atopic skin is different from nonlesional skin in adjacent areas. (2) Worsening atopic dermatitis and smaller bacterial diversity are strongly associated. (3) Application of emollients containing antioxidant and antibacterial components may increase microbiome diversity in atopic skin. Conclusion: The skin microbiome may be the next frontier in preventive health and may impact the approach to atopic dermatitis treatment.

Midface volume loss and contour deficiency are often treated using soft-tissue fillers capable of elevating and supporting facial features.To evaluate the effectiveness and safety of large gel particle hyaluronic acid with 0.3% lidocaine (LGP-HA-L) for the treatment of midface volume loss or contour deficiency.This 24-week, open-label study recruited adults aged 18 to 65 with bilateral moderate to substantial midface volume loss or contour deficiency (Medicis Midface Volume Scale (MMVS) score 3-4). The primary effectiveness measure was MMVS response (≥1-grade improvement) 8 weeks after treatment according to evaluators blinded to injection volume.All enrolled patients (n = 40; 85.0% female; mean ± SD age 53.1 ± 7.0 years) completed the study. Mean ± SD injected volume for both sides of the midface was 5.3 ± 2.5 mL. Week 8 MMVS response rates were 97.5% according to blinded evaluators and treating investigators and 90.0% according to patients; week 24 rates were 90.0%, 92.5%, and 82.5%, respectively. Global Aesthetic Improvement Scale response rates were 95.0% to 100.0% throughout the study. Adverse events were reported in 60.0% of patients and were mild or moderate; all resolved by study end and most within 1 week.Midface volume loss or contour deficiency may be safely and effectively corrected using LGP-HA-L.

Three hundred twenty-eight patients were examined and classified according to age (65–69, 70–74, 75–79, and ≥80 years) and degree of male pattern baldness Hamilton/Norwood Class I-VII. In addition, the inferior to superior height of potential temporal, parietal, and occipital donor sites containing at least eight hairs per 4-mm round circle was measured. A schematic drawing of the borders of this “safe” donor area containing permanently hair-bearing scalp with adequate hair density for transplanting is presented.

The development of topical cosmetic anti-aging products is becoming increasingly sophisticated. This is demonstrated by the benefit agents selected and the scientific approaches used to identify them, treatment protocols that increasingly incorporate multi-product regimens, and the level of rigor in the clinical testing used to demonstrate efficacy. Consistent with these principles, a new cosmetic anti-aging regimen was recently developed. The key product ingredients were identified based on an understanding of the key mechanistic themes associated with aging at the genomic level coupled with appropriate in vitro testing. The products were designed to provide optimum benefits when used in combination in a regimen format. This cosmetic regimen was then tested for efficacy against the appearance of facial wrinkles in a 24-week clinical trial compared with 0.02% tretinoin, a recognized benchmark prescription treatment for facial wrinkling. The cosmetic regimen significantly improved wrinkle appearance after 8 weeks relative to tretinoin and was better tolerated. Wrinkle appearance benefits from the two treatments in cohorts of subjects who continued treatment through 24 weeks were also comparable.

Background: Since the first published description in 1959, hair transplantation has progressed tremendously. Objective: This article provides an overview of hair transplantation and a discussion of selected controversies in hair transplantation. Methods: A review of the literature was undertaken to identify current controversies. Results: Hair transplantation has been refined considerably since it was first performed. As new methods are described, controversies arise. In hair transplantation, these include use of various forms of anaesthesia, the planning of the recipient site, method of harvesting the donor area, megatransplant sessions, isolated frontal forelock transplantation, and use of lasers in hair transplantation. Conclusion: Hair transplantation is a time-tested, highly effective, permanent and natural method of improving male-pattern baldness and female alopecia. Improvements in technique continue to be developed, requiring one to keep abreast of changes in the field in order to provide patients with the best hair coverage possible while maintaining a natural appearance.

A 58-year-old man with pleuritic chest pain and an indeterminate lung scan had normal results of Duplex ultrasound studies of the lower limbs and a normal pulmonary angiogram. Recurrent symptoms led to repeated pulmonary angiography and a diagnosis of pulmonary embolism. This case emphasizes the possibility of missing an initial, or developing a subsequent, pulmonary embolism despite a normal angiogram and reinforces the need for serial studies if a noninvasive strategy for the diagnosis of pulmonary embolism is to be employed.