Applicability of Patient-Reported Outcome Measures to Aesthetic Medicine Patient Archetypes.

BACKGROUND: Patient-reported outcome measures (PROMs) are valuable in understanding patient motivations, setting expectations, and ensuring satisfaction. As the aesthetic industry expands globally, factors that motivate the treatment goals of the aesthetic patient reflect evolving social, cultural, and commercial influences. OBJECTIVE: This article will assess the applicability of current PROMs used in aesthetic medicine to an increasingly diverse patient population and consider their ability to measure the underlying motives that drive different types of patients to pursue their specific goals. METHODS: PubMed database was searched for studies using PROMs to evaluate the motivations and expectations of aesthetic patients. RESULTS: Seven validated aesthetic PROM tools were reviewed against a backdrop of different patient segments as represented by the 4 patient archetypes: Positive Aging, Beautification, Correction, and Transformation. None of the tools could universally represent the individual motivations and expectations of all 4 patient archetypes. CONCLUSION: There is a need for updated PROMs in aesthetics that are applicable to patients with different motivations or expected outcomes than the traditional rejuvenation patient. PROMs that help decode patient motivations and that are developed with more diverse patient involvement will help aesthetic clinicians better understand the goals and expectations of new patient segments.

Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion.

BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.  Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.  Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145.

Integrative Assessment for Optimizing Aesthetic Outcomes When Treating Glabellar Lines With Botulinum Toxin Type A: An Appreciation of the Role of the Frontalis.

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.

Impact of Glabellar Injection Technique With DaxibotulinumtoxinA for Injection on Brow Position.

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.

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

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.

An Objective, Quantitative Assessment of Flexible Hyaluronic Acid Fillers in Lip and Perioral Enhancement.

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.

Efficacy and Safety of Flexible Hyaluronic Acid Fillers in Lip and Perioral Enhancement.

BACKGROUND: Since lips have a significant role in facial aesthetic perception, lip augmentation is an increasingly popular aesthetic procedure. OBJECTIVE: 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. METHODS AND MATERIALS: 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. RESULTS: 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. CONCLUSION: 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.

The Change of Plane of the Supratrochlear and Supraorbital Arteries in the Forehead-An Ultrasound-Based Investigation.

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.

DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).

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.

Relationship Between Vertical Glabellar Lines and the Supratrochlear and Supraorbital Arteries.

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.

Anatomy of the Superior and Inferior Labial Arteries Revised: An Ultrasound Investigation and Implication for Lip Volumization.

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 ±â€…9.6 years and a mean body mass index of 23.09 ±â€…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 ±â€…0.13 mm, whereas the depth of the inferior labial artery in the lower lip was 5.2 ±â€…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.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA 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 efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study.

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.

Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo.

BACKGROUND: 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. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: 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. RESULTS: 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. CONCLUSION: 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).

ATX-101 for reduction of submental fat: A phase III randomized controlled trial.

BACKGROUND: ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. OBJECTIVE: We sought to evaluate the efficacy and safety of ATX-101. METHODS: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. RESULTS: Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. LIMITATIONS: Follow-up was limited to 44 weeks. CONCLUSION: ATX-101 is an alternative treatment for SMF reduction.

Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds.

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 (+).
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.
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 (P<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 (P<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.

J Drugs Dermatol. 2016;15(8):1005-1010.

Adverse Reactions to Injectable Fillers.

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.

Evaluation of the Merz Hand Grading Scale After Calcium Hydroxylapatite Hand Treatment.

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.