Publications by authors named "Sue Cox"
Background: RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A.
Objective: Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL).
Methods: Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]).
Background: AbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009.
Objective: Pivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience.
Background: A well-defined jawline improves overall facial aesthetics, motivating patients to seek jawline augmentation.
Objectives: In this study we evaluated the safety and effectiveness of the hyaluronic acid injectable gel VYC-25L for restoring jawline definition.
Methods: In a US multicenter, evaluator-blinded study adults with grade 2 (moderate) or 3 (severe) Allergan Loss of Jawline Definition Scale (ALJDS) scores were randomized.
Background: Extending the duration of effect of botulinum toxins-by administering doses beyond those of the approved labels-has been an area of increasing interest in the field of aesthetics.
Objectives: The aim of this study was to investigate the safety and duration of effect of 40-unit (U) prabotulinumtoxinA-xvfs (twice the approved dose and concentration) for the treatment of moderate-to-severe glabellar lines.
Methods: A total of 154 adult patients were randomized 1:1:1 to a single treatment of either 40 U prabotulinumtoxinA-xvfs (PRA 40, 5 injections of 8 U/0.
Background: Botulinum toxin type A (BoNT-A) injections continue to be widely used as a common treatment for both males and females. According to a recent survey conducted by the International Society of Plastic Aesthetic Surgeons, the majority of patients receiving these injections are females between the ages 35 and 50.
Objectives: A post hoc analysis was conducted to examine whether there were variances in the effectiveness and safety of letibotulinumtoxinA for treating vertical glabellar lines between the broader female study population and a particularly defined group of female participants aged 35 to 50.
Background: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem.
Objective: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials.
Materials And Methods: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale.
Background: Despite the absence of Phase III clinical trial data to support their use, 3.4% of all neurotoxin treatments performed internationally for esthetic purposes in 2020 were performed in patients 65 years of age and older.
Objectives: To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in the subset of Phase III clinical trial participants who were 65 years of age and older.
Purpose: This article is prepared by the Association of Professors of Gynecology and Obstetrics Undergraduate Medical Education Committee and provides educators recommendations for optimizing inclusive education for our students with disabilities. Medical educators are increasingly encountering students with disabilities and have the responsibility of ensuring requirements are met.
Method: Medical education committee members from the US and Canada reviewed the literature on disabilities in medical student education to identify best practices and key discussion points.
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.
Infraorbital hollows are one of the most common target areas for facial aesthetic treatment; however, they are often perceived to be challenging to treat due to the complex anatomy of the periorbital area, concurrent deformities, and risk of complications. Treatment options include surgical (eg, lower eyelid blepharoplasty with fat transposition or injections) and nonsurgical approaches (eg, fillers). Among these approaches, filler injections have become common practice because they are minimally invasive and provide long-term patient satisfaction.
View Article and Find Full Text PDFBackground: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL).
Objective: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL.
Materials And Methods: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders).
Background: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs.
Objectives: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs.
Background: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U).
Aims: Evaluation of subject-reported indicators of treatment efficacy, satisfaction, and psychological well-being with ABO dose escalation.
Methods: A Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines.
Article Synopsis
- Letibotulinumtoxin A, a new neurotoxin derived from Clostridium botulinum, aims to treat glabellar lines (frown lines between the eyebrows) with its safety and efficacy evaluated through a Phase III clinical trial involving 355 participants.
- In the trial, 78.6% of subjects treated with letibotulinumtoxin A showed improvement in glabellar line severity at 4 weeks, compared to 0% in the placebo group, indicating its effectiveness.
- Overall, the study concluded that letibotulinumtoxin A is both effective and well-tolerated for reducing glabellar line severity.
Background: Using cannulas to deliver facial fillers may reduce adverse events (AEs) compared with needle injection.
Objective: To evaluate the safety and effectiveness of VYC-20L (20 mg/mL hyaluronic acid gel with lidocaine) via cannula for midface age-related volume deficit.
Materials And Methods: This multicenter, evaluator-blind, randomized, within-subject, controlled study enrolled adults with moderate to severe Mid-Face Volume Deficit Scale (MFVDS) scores.
High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice.
Aesthet Surg J Open Forum
December 2021
Background: For aesthetic treatment with botulinum neurotoxin type A (BoNTA), interest in maximizing treatment duration and efficacy has prompted study of doses higher than those used in registration studies. As data emerge, it is important that physicians understand how to apply study findings to their own practice so that patient demand is satisfied.
Objectives: To bring together leading experts in neuromodulators for a roundtable discussion on the implications of high-dose BoNTA studies for patient care.
Objective: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines.
Design: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study.
Methods: Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo.
Botulinum toxin serotype-A (BoNT-A) preparations are widely used to improve the appearance of wrinkles. While effective and well tolerated, patients require retreatment over time to re-establish the effects. There is growing interest from patients as to whether higher doses can prolong response without significantly increasing side effects.
View Article and Find Full Text PDFBackground: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.
Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.
Methods: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study.
Background: HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids.
Objective: To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids.
Background: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer.
Objective: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen.
Methods: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination.