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.

Comparison of Hyaluronic Acid Gel With (HARDL) and Without Lidocaine (HAJUP) in the Treatment of Moderate-To-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded Study.

BACKGROUND: Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly used to smooth age-related facial creases and wrinkles. OBJECTIVE: To compare efficacy and safety of a HA gel with lidocaine formulated by XpresHAn Technology (HARDL) with a HA gel without lidocaine produced by Hylacross technology (HAJUP) in the treatment of moderate-to-severe nasolabial folds. MATERIALS AND METHODS: Subjects (n = 162) received initial and touch-up injections with HARDL and HAJUP on either side of the face. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS: Mean (SD) Wrinkle Severity Rating Scale was improved by 1.1 (0.75) and 1.1 (0.68) with HARDL and HAJUP, respectively, at 24 weeks; improvements were sustained up to Week 48 with both treatments. Noninferiority of HARDL was demonstrated (mean difference -0.09 [95% confidence interval: -0.18 to -0.01], p = .032) at 24 weeks. Adverse events were reported in 43% subjects, 12% were treatment related, with a similar distribution for both treatments. CONCLUSION: Effectiveness and safety profiles of HARDL and HAJUP were comparable.

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.

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real-subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99-1.26] for clinically different image pairs and 0.45 [0.33-0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION: The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.

Development and Validation of a Photonumeric Scale for Assessment of Chin Retrusion.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. METHODS: The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). CONCLUSION: The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96-1.23] for clinically different image pairs and 0.53 [0.38-0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION: The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness.

Development and Validation of a Photonumeric Scale for Evaluation of Facial Fine Lines.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale. METHODS: The Allergan Fine Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live subject validation study (N = 289) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% CI] absolute score difference, 1.06 [0.92-1.21] for clinically different image pairs and 0.50 [0.38-0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point). CONCLUSION: The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94-1.26] for clinically different image pairs and 0.67 [0.51-0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION: The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.

Development and Validation of a Photonumeric Scale for Evaluation of Transverse Neck Lines.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of horizontal neck lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Transverse Neck Lines Scale. METHODS: The Allergan Transverse Neck Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject rating validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.22 [1.09-1.35] for clinically different image pairs and 0.57 [0.42-0.72] for not clinically different pairs). Intrarater agreement between the 2 live-subject rating validation sessions was substantial (mean weighted kappa = 0.78). Interrater agreement was substantial during the second rating session (0.73, primary end point). CONCLUSION: The Allergan Transverse Neck Lines Scale is a validated and reliable scale for rating of severity of neck lines.

Development and Validation of a Photonumeric Scale for Evaluation of Static Horizontal Forehead Lines.

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of static forehead lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Forehead Lines Scale. METHODS: The Allergan Forehead Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 295) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.06 [0.91-1.21] for clinically different image pairs and 0.38 [0.26-0.51] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was almost perfect (mean weighted kappa = 0.87). Interrater agreement was almost perfect during the second rating session (0.86, primary end point). CONCLUSION: The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.

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

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 0.90 [0.79-1.02] for clinically different image pairs and 0.33 [0.19-0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point). CONCLUSION: The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Repeated OnabotulinumtoxinA Treatments in Subjects With Crow's Feet Lines and Glabellar Lines.

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

Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines.

BACKGROUND: Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins. OBJECTIVE: To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration-mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120. RESULTS: Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated. CONCLUSION: A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.

A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint.

BACKGROUND: A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints. OBJECTIVE: To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown-as assessed by an investigator according to the facial wrinkle scale (FWS)-were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days. The primary efficacy variable was a composite endpoint consisting of patients who were 2-point or more responders at maximum frown on Day 30 according to the investigator's rating on the FWS, and 2-point or more responders at maximum frown on Day 30 according to the patient's assessment on a 4-point scale. Safety analyses were performed throughout the study. RESULTS: IncobotulinumtoxinA was statistically significantly more efficacious than placebo using a new rigorous composite endpoint (p < .0001). CONCLUSION: A single dose of 20 U of incobotulinumtoxinA is superior to placebo in the treatment of glabellar frown lines at Day 30 and is well-tolerated.

Real-world effectiveness and safety of collagenase clostridium histolyticum-aaes injections for the treatment of thigh cellulite in women: An open-label study interim analysis.

BACKGROUND: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved in the United States for moderate-to-severe cellulite in the buttocks of adult women. AIM: Interim analysis to evaluate efficacy/safety of CCH-aaes in the treatment of thigh cellulite. METHODS: Data were analyzed from a phase 3, open-label study (REAL). Women with mild-to-moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH-aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow-up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high-definition photography and 3D-image scanning of treatment areas. RESULTS: Twenty-two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of "improved" or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient-reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY-Q Appraisal of Cellulite Scale total score (possible range, 11-44). In PIXELS analysis, Day 90 3D-image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection-site bruising and pain (95.5% and 50.0% of patients, respectively). CONCLUSIONS: CCH-aaes treatment of mild-to-moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite-related bother.

A randomized, evaluator-blinded, controlled study of the effectiveness and safety of small gel particle hyaluronic acid for lip augmentation.

OBJECTIVES: To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation. METHODS: Adults (n = 180; aged 18-65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (≤1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study. RESULTS: Statistically significantly more MLFS responders (≥1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p < .001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p < .001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events. CONCLUSIONS: SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8 weeks, with visible results reported in the majority of participants 6 months after treatment.

Safety and tolerability of high-intensity focused ultrasonography for noninvasive body sculpting: 24-week data from a randomized, sham-controlled study.

BACKGROUND: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. OBJECTIVES: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. METHODS: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. RESULTS: Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. CONCLUSIONS: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.

A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion.

BACKGROUND: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. METHODS: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne ( n = 107) or no treatment ( n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. RESULTS: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) ( p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 ( p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. CONCLUSIONS: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.