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.

Update on Blindness From Filler: Review of Prognostic Factors, Management Approaches, and a Century of Published Cases.

BACKGROUND: Vision loss secondary to aesthetic filler treatment is a rare but disastrous complication. OBJECTIVES: The aim was to update the published cases of blindness after filler injection that have occurred since our group published reviews of 98 cases in 2015 and an additional 48 cases in 2019. METHODS: A literature review was performed to identify all cases of visual complications caused by filler injection published between September 2018 and March 2023. The cases were analyzed independently and in combination with previously reviewed cases. Analyses are based on the number of cases with data available. RESULTS: 365 new cases of partial or complete vision loss after filler injection were identified. The sites that were highest risk were the nose (40.6%), forehead (27.7%), and glabella (19.0%). The filler injected was hyaluronic acid in 79.6% of cases. The most common associated signs were ptosis (56.2%), ophthalmoplegia (44.1%), pain (31.2%), and skin changes (73.2%). Stroke-like features were seen in 19.2% of cases. Of the cases reporting visual outcomes (318), 6.0% experienced complete vision recovery, 25.8% had partial improvement in visual acuity, and 68.2% had no vision recovery. Partially preserved visual acuity at onset was a significant predictor of visual improvement (p < .001). The three most common treatments were subcutaneous hyaluronidase at or near the filler site (70.1%), systemic steroids (57.3%), and intra-arterial thrombolytic therapy (56.0%). No treatments were significantly associated with visual improvement (p > .05). CONCLUSIONS: Although blindness and stroke from fillers is a rare complication, practitioners who inject filler should have a thorough knowledge of prevention and management strategies.

Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study.

BACKGROUND: Simultaneous treatment of moderate-to-severe upper facial lines is reflective of real-world clinical practice. OBJECTIVE: To evaluate the efficacy and safety of daxibotulinumtoxinA-lanm for injection (DAXI) for simultaneous treatment of glabellar, forehead, and lateral canthal (LC) lines. METHODS: In this open-label, single-arm Phase 2 study, patients (48 enrolled, 94% completed, follow-up 24-36 weeks) received DAXI 40U (glabellar), 32U (forehead), and 48U (LC) lines. Key efficacy endpoints: percentages of patients achieving none/mild wrinkle severity (investigator-rated) for each upper facial line scale at Week 4. RESULTS: At Week 4, most patients achieved none/mild wrinkle severity (investigator-rated): glabellar (96%), forehead (96%), and LC (92%). Median times to loss of none/mild response (investigator- and patient-rated) among all patients were: 24.6 (glabellar), 20.9 (forehead), and 24.9 (LC) weeks; and 25.0, 24.0, and 28.1 weeks, respectively, among Week-4 responders. At Week 4, most patients reported improvements (Global Aesthetic Improvement Scale: 96%-98%) and high satisfaction rates (85%-98%). Five patients experienced treatment-related adverse events: injection-site erythema (3 patients/7 events), facial discomfort (2 patients/2 events), and headache (1 patient/1 event). No patients experienced eyebrow or eyelid ptosis. CONCLUSION: Simultaneous treatment of upper facial lines with DAXI was well tolerated and demonstrated high response rates, extended duration, and high patient satisfaction. CLINICAL TRIAL REGISTRY: https://clinicaltrials.gov/ct2/show/NCT04259086.

Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines.

DaxibotulinumtoxinA-lanm for injection (DAXI), a novel botulinum toxin type A formulation, contains a purified 150-kD core neurotoxin (daxibotulinumtoxinA) and proprietary stabilizing peptide (RTP004), and is approved for glabellar line treatment. As with any biologic product, DAXI may potentially be immunogenic and elicit unwanted antibody formation, possibly resulting in partial or complete treatment failure. The immunogenicity of DAXI was assessed in 2 double-blind, placebo-controlled, single-dose studies and an open-label safety study of up to 3 repeat treatments. Of the 2737 evaluable patients, none developed neutralizing antibodies to daxibotulinumtoxinA and 0.8% developed treatment-related nonneutralizing anti-daxibotulinumtoxinA-binding antibodies. Of evaluable patients exposed to RTP004 with either DAXI or placebo, 1.3% developed treatment-related anti-RTP004-binding antibodies, which were mostly transient. No patient developed binding antibodies to both daxibotulinumtoxinA and RTP004. All patients with treatment-related binding antibodies to daxibotulinumtoxinA or RTP004 achieved a clinical response (none or mild glabellar line severity) at Week 4 following each DAXI treatment cycle. The duration of clinical response was not different between treatment cycles when antibodies were detected vs when they were absent. Although the analysis population was small compared to the number of patients likely to receive repeated treatment in clinical practice, these results suggest that DAXI administration at the approved glabellar lines dose has low immunogenic potential and that nonneutralizing antibodies to daxibotulinumtoxinA or RTP004 occur infrequently and often transiently, and have no impact on clinical efficacy, safety, or duration of action. Real-world data encompassing larger numbers of patients is needed to substantiate these results.

Defining Skin Quality: Clinical Relevance, Terminology, and Assessment.

BACKGROUND: Flawless skin is one of the most universally desired features, and demand for improvements in skin quality is growing rapidly. Skin quality has been shown to substantially impact emotional health, quality of life, self-perception, and interactions with others. Although skin quality improvements are a common end point in studies of cosmeceuticals, they are rarely assessed in clinical studies of other aesthetic treatments and products. Descriptive terminology for skin quality parameters also varies considerably within the aesthetic field, relying on a range of redundant and occasionally contradictory descriptors. In short, skin quality has not been clearly defined. OBJECTIVE: The goal of this review is to highlight the importance of skin quality to patients and physicians, explore known and unknown factors comprising skin quality, and provide clarity regarding terminology, descriptors, and evaluation tools for assessing skin quality. MATERIALS AND METHODS: A review of the literature on skin quality was performed without limitation on publication date. Relevant articles are presented. RESULTS AND CONCLUSION: We propose a framework of attributes contributing to skin quality rooted in 3 fundamental categories-visible, mechanical, and topographical-with the aim to provide information to help guide clinicians and inform future clinical studies.

Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.

BACKGROUND: ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2). OBJECTIVES: The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101. METHODS: REFINE study patients who maintained ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after their last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). The primary endpoint was CR-1 response at Years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored. RESULTS: In total, 224 patients (ATX-101, n = 113; placebo, n = 111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group than in the placebo group at Year 1 (86.4% vs 56.8%; P < 0.001), Year 2 (90.6% vs 73.8%; P = 0.014), and Year 3 (82.4% vs 65.0%; P = 0.03). Most (74%) ATX-101‒treated patients satisfied at 12 weeks remained satisfied at Year 3. Significant reductions from baseline in psychological impact scores were sustained through Year 3 (P < 0.001). No new treatment-related adverse events were reported. CONCLUSIONS: Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.

Photographic assessment of postsurgical facial scars epidermally sutured with rapidly absorbable polyglactin 910 or nylon: A randomized clinical trial.

BACKGROUND: Surgeons use absorbable and nonabsorbable sutures for epidermal wound closure. No large, randomized studies have compared the effect of these suture types on facial scar appearance. OBJECTIVE: To assess postsurgical facial scar appearance using either rapidly absorbable polyglactin 910 or nylon for epidermal closure. METHODS: Randomized, blinded, split-scar clinical trial. A total of 105 patients with facial wounds resulting from Mohs micrographic surgery excisions were randomly assigned for epidermal closure with rapidly absorbable 5-0 polyglactin 910 (Vicryl Rapide) on one half of the repair and 5-0 nylon (Ethilon) on the other half. Two physicians (1 dermatologist and 1 plastic surgeon), unaware of the original suture location, examined photographs of each healed wound at 6 months after surgery and graded the appearance of each half of the scar using the visual analog scale, wound evaluation scale, and Stony Brook Scar Evaluation Scale. RESULTS: At 6 months, there was no significant difference in the combined mean (standard deviation) visual analog scale scores (83.1 [14.2] and 83.0 [13.7]), Stony Brook Scar Evaluation Scale scores (4.3 [0.9] and 4.4 [0.9]), or wound evaluation scale scores (5.3 [1.1] and 5.2 [1.1]) for rapidly absorbable polyglactin 910 versus nylon (P = .72, .57, and .21, respectively). LIMITATIONS: Single institution. CONCLUSIONS: Both rapidly absorbable polyglactin 910 and nylon sutures placed through the epidermis resulted in an equivalent photographic appearance of facial scars at 6 months after surgery.

Retrospective review of delayed adverse events secondary to treatment with a smooth, cohesive 20-mg/mL hyaluronic acid filler in 4500 patients.

BACKGROUND: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V). OBJECTIVE: To examine the occurrence of HA-V DAEs and identify patterns and characteristics. METHODS: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. RESULTS: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident. LIMITATIONS: The retrospective nature made it difficult to capture time to resolution or remember potential triggers. CONCLUSION: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part I: Definitions, Mechanisms of Action, and Technical Specifications.

BACKGROUND: Platelet-rich plasma (PRP) is an increasingly popular treatment modality for various dermatologic conditions, but there are limitations in both the published literature and clinician knowledge. OBJECTIVE: To create a high-yield, in-depth analysis of PRP in procedural dermatology by reviewing available data on its role in hair restoration, soft-tissue remodeling, resurfacing, and rejuvenation; identifying practice gaps and controversies; and making suggestions for future research that will establish dermatologists as pioneers of regenerative medicine. MATERIALS AND METHODS: A 2-part systematic review and expert analysis of publications before October 2018. RESULTS AND CONCLUSION: Most studies on PRP report favorable outcomes with the strongest level of evidence existing for androgenetic alopecia followed by postprocedure wound healing, scar revision, striae, rejuvenation, and dermal filling. There is a dearth of large randomized controlled trials, considerable heterogeneity in the variables studied, and lack of specificity in the preparatory protocols, which may influence clinical outcomes. Future investigations should use consistent nomenclature, find ideal solution parameters for each cutaneous indication, determine significant outcome metrics, and follow double-blinded, randomized, controlled methodologies. Addressing these deficiencies will take sound scientific inquiry but ultimately has the potential to benefit the authors' specialty greatly.

The Physician's Guide to Platelet-Rich Plasma in Dermatologic Surgery Part II: Clinical Evidence.

BACKGROUND: Platelet-rich plasma (PRP) is an increasingly popular treatment modality for various dermatologic conditions, but there are limitations in both the published literature and clinician knowledge. OBJECTIVE: To create a high-yield, in-depth analysis of PRP in procedural dermatology by reviewing available data on its role in hair restoration, soft-tissue remodeling, resurfacing, and rejuvenation; identifying practice gaps and controversies; and making suggestions for future research that will establish dermatologists as pioneers of regenerative medicine. MATERIALS AND METHODS: A two-part systematic review and expert analysis of publications before October 2018. RESULTS AND CONCLUSION: Most studies on PRP report favorable outcomes with the strongest level of evidence existing for androgenetic alopecia followed by postprocedure wound healing, scar revision, striae, rejuvenation, and dermal filling. There is a dearth of large randomized controlled trials, considerable heterogeneity in the variables studied, and lack of specificity in the preparatory protocols, which may influence clinical outcomes. Future investigations should use consistent nomenclature, find ideal solution parameters for each cutaneous indication, determine significant outcome metrics, and follow double-blinded, randomized, controlled methodologies. Addressing these deficiencies will take sound scientific inquiry but ultimately has the potential to benefit the authors' specialty greatly.

Photoprotection With Mineral-Based Sunscreens.

BACKGROUND: Although chemical sunscreens have traditionally been at the forefront of sun protection, safety concerns and increasing awareness of the environmental impact of personal-care products have led to greater interest in the use of mineral blockers as photoprotective agents. OBJECTIVE: To examine the safety and efficacy of mineral-based sunscreens to allow patients to make informed choices about ultraviolet (UV) protection. MATERIALS AND METHODS: A review of the literature was performed using the PubMed database. RESULTS: This article provides an overview of physical blockers and focuses on the efficacy of mineral sunscreens in offering broad-spectrum UV protection and safety concerns, including the controversy surrounding the use of nanoparticles. Practical tips for application are also reviewed. CONCLUSION: Mineral sunscreens are an attractive, efficacious option for consumers who prefer alternative choices in sun protection.

Retention Rates Among Patients Undergoing Multimodal Facial Rejuvenation Treatment Versus a Single Monotherapy in Cosmetic Dermatology Practices.

BACKGROUND: Facial aging is a multifactorial process. Accordingly, expert opinion has largely been unanimous in that multimodal treatment targeting various aspects of the aging face provides superior results. However, there is a lack of studies exploring patient response. OBJECTIVE: To compare patient retention between triple multimodal facial rejuvenation treatment (neuromodulator, filler, and energy-based therapy) and monotherapy (neuromodulator alone). METHODS: A retrospective, multicenter (the United States, Canada, and Germany) study was performed. Cases were retrieved from July 2015 to June 2016. The study compared patients who had undergone monotherapy (neuromodulator), combined multimodal treatment (neuromodulator, filler, and energy-based therapy on the same day), and sequential multimodal treatment (neuromodulator, filler, and energy-based therapy over a 1-year period). Retention rates were calculated. RESULTS: A total of 509 patients were included: monotherapy (300), sequential multimodal treatment (93), and combined multimodal treatment (116). Patient retention was significantly higher in the combined multimodal treatment group compared with the monotherapy and sequential multimodal treatment groups (p < .001). Subgroup analysis revealed similar trends at all sites. CONCLUSION: Based on retention rates, patients are more likely to return to the clinic when multiple treatment modalities are used during 1 encounter. These data further solidify the importance of multimodal therapy for both the provider and the patient.

Attitudes Toward Submental Fat Among Adults in the United States.

BACKGROUND: Excess submental fat (SMF) can cause submental fullness resulting in negative perceptions of individuals. However, the impact of SMF on perceptions of social traits has not been well studied. OBJECTIVE: To characterize the impact of SMF on external value judgments in adults in the United States. METHODS: Respondents completed an online survey in which they reacted to statements about individuals with varying grades of SMF. Attributes were rated on a scale from 0 to 100 with higher scores for more positive attributes. RESULTS: Similar proportions of respondents (N = 1996) indicated that women and men with double chins were less attractive than those without (91% and 90%, respectively). A double chin was more likely to be noticed on a woman than on a man (78% of respondents). With increasing SMF, individuals were perceived as significantly less likeable, intelligent, happy, active, and easygoing. Those with greater amounts of SMF were rated as significantly less attractive than those with less SMF. For all attributes, male respondents rated all individuals lower than female respondents did. CONCLUSION: Results from this study provide further evidence of negative perceptions of individuals with SMF. Aesthetics of the submental area, especially SMF, likely impact the overall assessment of attractiveness and social attributes.

Dermatologic Training and Practice in Canada: An In-Depth Review [Formula: see text].

As part of an in-depth review of the specialty for the Royal College of Physicians and Surgeons of Canada (RCPSC), the Dermatology Working Group (DWG) was tasked with leading a comprehensive and objective analysis of the current state of Dermatology practice and training patterns in Canada. Preliminary research for the report was conducted in 3 areas: a jurisdictional analysis, a literature review, and a landscape overview. The results of this research were published in the spring 2019 edition of the Journal of Cutaneous Medicine and Surgery. Various factors impacting the discipline were explored, including trends in the workforce, population needs, accessibility, and wait times, as well as issues in undergraduate and postgraduate medical education. The DWG, supported by the RCPSC's Office of Specialty Education, used information gained from the reviews, a national survey, and stakeholder perspectives to develop recommendations that address the current challenges and build upon opportunities for advancement in the specialty.

Personal (Self) Perceptions of Submental Fat Among Adults in the United States.

BACKGROUND: Satisfaction with discrete facial areas influences self-perceptions of attractiveness, self-esteem, and quality of life. Currently, there is a lack of understanding of how the submental area impacts feelings and behaviors. OBJECTIVE: To characterize the effects of submental fat (SMF) on feelings/emotions and actions/behavior among adults in the United States. METHODS: Online health-based surveys recruited approximately 400 adults (18-65 years) in each of 5 categories based on the respondent's assessment of their SMF. Respondents either agreed or disagreed with 17 statements regarding their feelings/emotions and actions/behaviors related to the area underneath their chin. RESULTS: Overall, 1996 respondents were included (equal distribution of males/females; mean age, 41.9 years). Even a slight amount of chin fat was associated with negative feelings and behaviors. As SMF increased, so did the number of respondents reporting negative self-perceptions such as being embarrassed by the area under their chin. In general, a greater percentage of female compared with male respondents reported negative feelings and behavioral changes due to their submental area. CONCLUSION: Excess SMF can have a substantial negative effect on a person's feelings of attractiveness and behaviors. Reduction of SMF may not only improve one's appearance, but also may enhance one's self-esteem.

Ten-Year and Beyond Follow-up After Treatment With Highly Purified Liquid-Injectable Silicone for HIV-Associated Facial Lipoatrophy: A Report of 164 Patients.

BACKGROUND: Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. OBJECTIVE: To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. METHODS: Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. RESULTS: One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. CONCLUSION: Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.

Dermatologic Training and Practice in Canada: A Historical Overview.

The specialty of dermatology is constantly changing to meet the medical needs of our society. The discipline is in flux because of a variety of factors such as growing population needs, technological advancements, fiscal restraint, and demographic changes. As part of an in-depth review of the specialty, the Dermatology Working Group (DWG) for the Royal College of Physicians and Surgeons of Canada sought to determine whether the current training configuration is suitably preparing graduates to meet the societal health needs of dermatology patients. In this first of a 2-part series, the authors conducted comprehensive literature and historical reviews and a jurisdictional analysis to understand the current state of dermatology practice in Canada. Herein, they explore trends in the dermatology workforce, population needs, accessibility, and wait times, as well as issues in undergraduate and postgraduate medical education. In a subsequent publication, the DWG will utilize information gained from this historical analysis and jurisdictional review, stakeholder perspectives, and a national survey to shape the future of dermatology training in Canada.

Update on Avoiding and Treating Blindness From Fillers: A Recent Review of the World Literature.

BACKGROUND: Sudden loss of vision secondary to filler treatments is a rare but catastrophic complication. OBJECTIVES: The aim of this study was to update the published cases of blindness after filler injection that have occurred since we published our review of 98 cases in 2015, and to discuss prevention and management strategies. METHODS: A literature review was performed to identify all cases of visual complications caused by filler injection identified between January 2015 and September 2018. RESULTS: Forty-eight new published cases of partial or complete vision loss after filler injection were identified. The sites that were highest risk were the nasal region (56.3%), glabella (27.1%), forehead (18.8%), and nasolabial fold (14.6%). Hyaluronic acid filler was the cause of this complication in 81.3% of cases. Vision loss, pain, ophthalmoplegia, and ptosis were the most common reported symptoms. Skin changes were seen in 43.8% of cases and central nervous system complications were seen in 18.8% of cases. Ten cases (20.8%) experienced complete recovery of vision, whereas 8 cases (16.7%) reported only partial recovery. Management strategies varied greatly and there were no treatments that were shown to be consistently successful. CONCLUSIONS: Although the risk of blindness from fillers is rare, practitioners who inject filler should have a thorough knowledge of this complication including prevention and management strategies.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials.

BACKGROUND: ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. OBJECTIVES: To evaluate the efficacy and safety of ATX-101 by treatment session. METHODS: This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. RESULTS: In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101-treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. CONCLUSIONS: Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3.