Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

Increasing precision during neuromodulator injections for frontal rhytids-Using ultrasound imaging to identify the line of convergence.

BACKGROUND: Recent research introduced the concept of the "line of convergence" as a guide for injectors to enhance precision and avoid complications when treating the frontalis muscle with toxins. However, currently, no pre-injection ultrasound scanning is employed to increase precision and reduce adverse events when searching for the line of convergence. OBJECTIVE: To explore the feasibility and practicality of implementing pre-injection ultrasound scanning into aesthetic neuromodulator treatments of the forehead. METHODS: The sample of this study consisted of n = 55 volunteers (42 females and 13 males), with a mean age of 42.24 (10.3) years and a mean BMI of 25.07 (4.0) kg/m2. High-frequency ultrasound imaging was utilized to measure the thickness, length, and contractility of the frontal soft tissue and to determine the precise location of the line of convergence during maximal frontalis muscle contraction. RESULTS: The results revealed that the line of convergence was located at 58.43% (8.7) of the total forehead height above the superior border of the eyebrow cilia without a statistically significant difference between sex, age, or BMI. With frontalis muscle contraction, the forehead shortens in males by 25.90% (6.5), whereas in females it shortens only by 21.74% (5.1), with p < 0.001 for sex differences. CONCLUSION: This study demonstrated the feasibility and practicality of pre-injection ultrasound scanning for facial aesthetic neuromodulator treatments. Knowing the location of the line of convergence, injectors can determine precisely and on an individual basis where to administer the neuromodulator deep or superficial or when the injection location is at risk to cause eyebrow ptosis.

A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

BACKGROUND: Hyaluronic acid injections are increasingly used for correction of infraorbital hollows (IOHs). OBJECTIVES: Examination of effectiveness (IOH correction) and safety of Restylane® EyelightTM hyaluronic acid (HAEYE, Galderma, Uppsala, Sweden) injections. METHODS: Subjects with moderate/severe IOHs, assessed using the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (via needle/cannula) (Day 1+optional Month-1 touch up) or no-treatment control. Primary endpoint was blinded evaluator-reported Month-3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement (GAIS), subject-reported satisfaction (FACE-Q™ satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 subjects were randomized. Month 3 GIHS responder rate was significantly higher with HA-EYE (87.4%) versus control (17.7%; p<0.001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (p=0.967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) versus 14.1-16.2 (control) through Month 12. Subjects reported looking younger (≥71%) and less tired (≥79%) with reduced under-eye shadows (≥76%) and recovered within 3-5 hours, post-treatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month-12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores: 72.5-72.8). Forty subjects (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSION: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring.

The "Central Tendency Bias" in the assessment of facial attractiveness in group-based and individual ratings-A survey-based study in 727 volunteers.

BACKGROUND: The increasing number of esthetic procedures emphasizes the need for effective evaluation methods of outcomes. Current practices include the individual practitioners' judgment in conjunction with standardized scales, often relying on the comparison of before and after photographs. This study investigates whether comparative evaluations influence the perception of beauty and aims to enhance the accuracy of esthetic assessments in clinical and research settings. OBJECTIVE: To compare the evaluation of attractiveness and gender characteristics of faces in group-based versus individual ratings. METHODS: A sample of 727 volunteers (average age of 29.5 years) assessed 40 facial photographs (20 male, 20 female) for attractiveness, masculinity, and femininity using a 5-point Likert scale. Each face was digitally edited to display varying ratios in four lip-related proportions: vertical lip position, lip width, upper lip esthetics, and lower lip esthetics. Participants rated these images both in an image series (group-based) and individually. RESULTS: Differences in the perception of the most attractive/masculine/feminine ratios for each lip proportion were found in both the group-based and individual ratings. Group ratings exhibited a significant central tendency bias, with a preference for more average outcomes compared with individual ratings, with an average difference of 0.50 versus 1.00. (p = 0.033) CONCLUSION: A central tendency bias was noted in evaluations of attractiveness, masculinity, and femininity in group-based image presentation, indicating a bias toward more "average" features. Conversely, individual assessments displayed a preference for more pronounced, "non-average" appearances, thereby possibly pointing toward a malleable "intrinsic esthetic blueprint" shaped by comparative context.

Identifying Levels of Competency in Aesthetic Medicine: A Questionnaire-Based Study.

BACKGROUND: In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amidst an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by non-academic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES: To identify levels of competency for the aesthetic practitioner and for necessary achievement milestones during the educational path from novice to expert injector. METHODS: A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS: Regardless of medical specialty and experience level, an average of 3.85 (1.8) years, 786.4 (2,628) filler injections, and 549.9 (1,543) toxin injections was estimated to progress from novice to advanced injector, while an average of 6.10 (3.7) years, 1,842.2 (4,793) filler injections, and 1,308.5 (3,363) injections was estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS: This study establishes an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1,840 filler and 1,310 neuromodulator injections for expertise. It also identifies critical facial regions for targeted treatments by different expertise levels.

A Prospective, Multicenter, Evaluator-Blind, Randomized, Controlled Study of Belotero Balance (+), a Hyaluronic-Acid Filler with Lidocaine, for Correction of Infraorbital Hollowing in Adults.

BACKGROUND: The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be used to correct volume deficit in the under-eye area, restoring a more youthful appearance. OBJECTIVES: To demonstrate the effectiveness and safety of a Cohesive Polydensified Matrix® (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance® (+)) for correcting volume deficit in the IOH. METHODS: Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated by the MIHAS. Adverse events were recorded over a 76-week period. RESULTS: The estimated average response rate (≥ 1 point MIHAS improvement) was 80.6% [95% confidence interval (CI): 71.4%, 87.4%] in treated patients and 1.9% [95% CI: 0.3%, 10.2%] in controls at Week 8. The difference in estimated response rates was 78.7% [95% CI: 66.3%, 85.6%], demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88/97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. CONCLUSIONS: Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.

Interventional and device treatment of the periocular area.

Growth in the research, innovation, and development of laser and energy-based technologies over the past few decades has led to dramatic increases in treatment options for dermatologic and cosmetic concerns of the periorbital area. We highlight recent treatment options using laser and energy-based devices for the clearance of periocular pigmented lesions, including solar lentigines and nevus of Ota; vascular lesions, including port-wine birthmarks, infantile hemangiomas, superficial telangiectasias, and reticular veins; laser ablation of benign tumors, such as xanthelasma; cosmetic rejuvenation; treatment of infraorbital dark circles and festoons; laser removal of eyebrow and eyeliner tattoos; and device-based treatment of chronic dry eyes.

Understanding Platysma Muscle Contraction Pattern and Its Relationship to Platysmal Banding: A Real-Time Ultrasound Study.

BACKGROUND: Addressing neck contouring with surgical and nonsurgical aesthetic procedures includes understanding the origin of platysmal banding. A theory was postulated to explain this phenomenon by isometric vs isotonic muscular contraction patterns. However, no scientific proof had been provided to date for its correctness. OBJECTIVES: The aim of this study was to confirm the correctness of the platysmal banding theory based on isometric vs isotonic muscular contractions. METHODS: Eighty platysma muscles from 40 volunteers (15 males and 25 females) were investigated (mean age 41.8; SD 15.2 years; mean BMI of 22.2; SD 2.3 kg/m2). Real-time ultrasound imaging was utilized to measure the increase in local muscle thickness inside and outside of a platysmal band as well as platysma mobility. RESULTS: Within a platysmal band, the local thickness of the muscle increases during muscular contractions by 0.33 mm (37.9%; P < .001). Outside of a platysmal band the thickness of the platysma muscle decreased by 0.13 mm (20.3%; P < .001). It was identified that within a platysmal band no gliding was detectable, whereas outside of a band an average muscle gliding of 2.76 mm was observed. CONCLUSIONS: The results confirm the correctness of the isometric vs isotonic platysma muscle contraction pattern theory: isotonic muscle contraction (gliding without increase in tension and therefore in muscle thickness) vs isometric muscle contraction (no gliding but increase in tension and therefore in muscle thickness). These 2 types of contraction patterns occur within the platysma simultaneously and are an indicator for zones of adhesion in the neck to guide surgical and nonsurgical aesthetic procedures.

Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite.

BACKGROUND: A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit. OBJECTIVE: To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz. METHODS: This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study. RESULTS: For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred. CONCLUSION: Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.

Is constant needle motion during soft tissue filler injections a safer procedure? A theoretical mathematical model for evaluating patient safety.

BACKGROUND: The safety rationale behind the constant needle motion injection technique is based on the assumption that due to the constant needle motion and simultaneous soft tissue filler material administration a smaller amount of product per area may be injected into an artery if an artery within the range of the moving needle is inadvertently entered. OBJECTIVE: To perform mathematical calculations for determining the probability for causing intra-arterial product administration when constantly moving the needle during facial aesthetic soft tissue filler injections. METHODS: This study was designed as a theoretical investigation into the probabilities for causing adverse events due to intravascular injection of soft tissue filler material when constantly moving a 27-G needle during facial soft tissue filler administration. RESULTS: It was revealed that with a higher number of conducted injection passes a greater soft tissue area can be covered by the needle. The odds of encountering an artery within the covered soft tissue volume and the odds of injecting any volume greater than zero into the arterial blood stream increases with the number of performed injection passes. This increase is greatest between 1 and 10 performed injection passes. CONCLUSION: This model demonstrates that the constant needle motion technique increases the probability of encountering an artery within the treatment area and thus increases the odds for intra-arterial product administration. The constant needle motion technique does not increase safety but rather may increase the odds of causing intra-arterial product administration with the respective adverse consequences for the patient.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.

Purpose: Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). Patients and Methods: A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Results: Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. Conclusion: RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.

Facial aesthetic minimally invasive procedure: More than just vanity, a social-psychological approach.

BACKGROUND: Due to the great importance of the face in social interaction, minimally invasive treatments can-besides their ability to rejuvenate and enhance beauty-also change the way facial impressions of a person are perceived. In recent literature, three main character traits (attractiveness, trustworthiness, and competence) and subdomains essential for facial perception were described. OBJECTIVE: To investigate whether minimally invasive procedures truly influence different character traits when evaluated by independent, objective observers. METHODS: Photographs of n = 34 female faces before and after treatment with injectable fillers and botulinum toxin were rated by 393 individuals without aesthetic background with regards to different character traits on a 7-point Likert scale. Tests for dimensionality were performed, and composite scores of the impressions underlying each of the three dimensions were created and compared using within-subjects t tests. RESULTS: Treatments statistically significantly improved the overarching character trait domains attractiveness, trustworthiness, and competence in posttreatment photographs compared with pretreatment. Posttreatment ratings of the respective subdomains also showed a statistically significant difference compared with pretreatment photographs, with the exception of the subdomain dominance which failed to reach statistical significance. CONCLUSION: Impressions of facial attractiveness, trustworthiness, and competence can be improved by injectables while the naturalness of the face is left intact. An implication is that the improvement of traits highly relevant to social interaction will accommodate the patient's desires for beautification and rejuvenation.

Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing.

BACKGROUND: The infraorbital hollow is characterized by a sunken hollowing appearance of the junction between the lower eyelid and the cheek. Dermal fillers provide a suitable option to reduce the appearance of infraorbital hollowing. To objectively evaluate treatmentrelated improvements in clinical practice and research, a validated photonumeric scale is needed. OBJECTIVE: To present the scale development methods for the Merz Infraorbital Hollow Assessment Scale and establish its reliability and clinical relevance. METHODS: A 5-point photonumeric scale was developed to objectively assess the infraorbital hollowing among subjects of varying sex, age, and skin type. Intra- and inter-rater reliability was evaluated using live assessments conducted 2 weeks apart. The clinical relevance of a 1-point difference in scale-severity grade was evaluated through side by-side comparisons of photographs with either same grade or a one-grade difference. RESULTS: The scale demonstrated excellent reliability when used by trained physicians and other healthcare practitioners. Intra-rater agreement between the 2 live-subject rating sessions was nearly perfect. Substantial inter-rater agreement between the raters from both live sessions was also demonstrated. The mean absolute difference (95% confidence interval) in scale ratings was 1.08 (1.02, 1.14) for "clinically different" pairs and was 0.34 (0.27, 0.41) for "clinically same" pairs, suggesting a 1-point difference is clinically relevant. CONCLUSION: The Merz Infraorbital Hollow Assessment Scale is a validated, reliable, and clinically relevant photonumeric scale for rating infraorbital hollowing. The scale maintains its validity and reliability with reproducible results across a diverse group of males and females of various ages and Fitzpatrick Skin Types. J Drugs Dermatol. 2023;22(1):74-81.doi:10.36849/JDD.7191.

Two-Step Skincare Regimen Addressing Aging in Three Unique Geographic Locations: A Prospective, Multi-Center, Open-Label Study.

BACKGROUND: Extrinsic factors including solar radiation and air pollution significantly impact facial skin aging. The efficacy and tolerability of a 2-step skincare regimen consisting of a vitamin C antioxidant serum (VCAS) and a 100% mineral tinted sunscreen moisturizer (TSM) were evaluated in women with hyperpigmented and photodamaged facial skin exposed to beach, mountain, and river-traversed basin city stressors. METHODS: This was an institutional review board (IRB)-approved, multi-center, prospective, open-label study involving healthy subjects. Thirty-six females aged 35 to 60 years with Fitzpatrick Skin Types I to V and exhibiting moderate to severe hyperpigmentation and moderate photodamage were recruited. The VCAS was applied to the global face twice-daily (morning and evening), and the TSM was applied in the morning with at least 2 reapplications during daily activity for 12 weeks. Clinical grading with a validated scale, standardized photography, and a self-assessment questionnaire were performed at baseline and weeks 4, 8, and 12. RESULTS: Statistically significant improvements were shown in clinically graded efficacy parameters at weeks 4, 8, and 12. Subjects showed an average improvement of 11.7%, 14.9%, and 19.1% in overall photodamage and an average improvement of 19.5%, 23.4%, and 24.5% in clarity/brightness at weeks 4, 8, and 12, respectively. Forehead lines and cheek lines demonstrated clinically significant improvement from baseline to week 12. Both products were well-tolerated and well-perceived by subjects. CONCLUSION: The 2-step skincare regimen was well-tolerated and effective in improving extrinsic signs of facial aging induced by solar radiation and air pollution stressors after 12 weeks of use. J Drugs Dermatol. 2023;22(1):16-22. doi:10.36849/JDD.7154.

Impact of DaxibotulinumtoxinA for Injection on Brow Position and Frontalis Muscle Activity Following Treatment of Glabellar Lines.

BACKGROUND: Botulinum toxin type A (BoNTA) injections for the treatment of facial lines may lead to pleasant or undesirable changes in eyebrow height and position. OBJECTIVES: The aim of this study was to evaluate the impact of glabellar injection of DaxibotulinumtoxinA for Injection (DAXI), a novel BoNTA formulation, on eyebrow position and frontalis activity. METHODS: This study involved the post hoc analysis of adult patients from the Phase 2a forehead lines (FHL, N = 60) and open-label safety (OLS, N = 175) studies who received a single dose of DAXI 40 U to the glabella and for whom facial photographs were taken at rest and at maximum eyebrow elevation. Median vertical and horizontal displacement of the brows and median forehead strain (an objective quantitative assessment of frontalis activity) from baseline to 2 weeks after glabellar DAXI injection were measured. RESULTS: Two weeks after glabellar DAXI injection, vertical eyebrow movement (at rest) of the lateral brow was observed. In both studies, vertical movement was greatest in the lateral (0.6-0.9 mm) and mid (0.5-0.7 mm) brow regions; movement in the medial brow was negligible (0-0.23 mm). In both studies, a graded reduction in forehead strain was observed 2 weeks post glabellar DAXI injection, with the greatest reduction being in the lower segment (FHL, -73%; OLS, -82%). Treatment with DAXI showed improvements in FHL wrinkle severity. CONCLUSIONS: Glabellar injection of DAXI showed a positive reduction in dynamic frontalis activity that maintained or had a positive effect on eyebrow position. Vertical movement of the brow was suggestive of an improved eyebrow shape with a mild lateral arch.

Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles.

Micro-coring technology (MCT) removes cores of skin without formation of scars, thereby tightening skin and reducing skin wrinkling. The purpose of this study was to evaluate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of facial wrinkles. Methods: This prospective, multicenter clinical trial included fifty-one subjects who underwent MCT treatments of the mid to lower face. The primary study endpoint was change in the Lemperle Wrinkle Severity Scale. Secondary study endpoints were change in Global Aesthetic Improvement Scale (GAIS), participant satisfaction, and evaluation of treatment outcome by an independent review panel. All study endpoints were evaluated at 1, 7, 30, 60, and 150 or 180 days after treatment. Procedure bleeding, pain, and early healing profile were also captured. Results: The mean Lemperle Wrinkle Severity Scale change was 1.3 grades. Improvement in the GAIS was reported for 89.7% (87/97) of treated sites, and average improvement of GAIS was 1.5. Participants reported satisfaction with 85.6% of treatment sites. The independent review panel correctly identified 84.2% of the post-treatment photographs as post-treatment. Procedure bleeding and pain was mild with good healing responses and patient-reported average down time of 3 days. Conclusions: The results of this study demonstrate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of moderate to severe facial wrinkles. MCT led to significant improvement of facial wrinkles with high patient satisfaction and fast recovery time and should be considered in patients who are seeking minimally invasive treatment for wrinkles of the face.

Expert Recommendations on the Use of Hyaluronic Acid Filler for Tear Trough Rejuvenation.

Restylane® Lidocaine is one of the most widely used hyaluronic acid (HA) fillers to replace lost or displaced volume during tear trough correction. Patient goals for tear trough correction include looking less tired or removing dark circles and this may be achieved by administering HA filler into the infraorbital region to correct the lower eyelid relative to the volume deficit, thereby smoothing the transition from the lower eyelid to the cheek. To achieve patient satisfaction and consistent results with Restylane, optimal application is essential; however, clinical guidance based on experience is limited. This paper reflects the recommendations of an interdisciplinary expert panel for the use of Restylane in correcting tear trough deformity, including patient selection, dosing, injection technique, and post-treatment care. Recommendations were discussed and agreed as a consensus, according to cross-sectional expertise and clinical experience. J Drugs Dermatol. 2022;21(4):387-392. doi:10.36849/JDD.6597.