Improving Neck and Jawline Aesthetics With OnabotulinumtoxinA by Minimizing Platysma Muscle Contraction Effects: Efficacy and Safety Results in a Phase 3 Randomized, Placebo-Controlled Study.

BACKGROUND: Platysma prominence (PP) describes the noticeable appearance of the platysma muscle upon contraction, causing less defined jawline contour and vertical neck bands. OBJECTIVES: To assess safety and efficacy of onabotulinumtoxinA for improvement of PP in adults. METHODS: Participants with moderate-to-severe (Grade 3 to 4) PP at maximum contraction received onabotulinumtoxinA or placebo on Day 1 and were monitored for 120 days. OnabotulinumtoxinA dosage (26, 31, or 36 U) was customized based on baseline PP severity on each side of the neck. RESULTS: Efficacy analyses were conducted in the intent-to-treat (ITT) population (all randomized participants), and modified ITT population (mITT; psychosocially impacted by PP appearance). Results from ITT and mITT populations were comparable. As assessed by investigators, 76.7% of onabotulinumtoxinA mITT participants achieved ≥1-grade improvement versus 21.2% in the placebo group, and 41.0% versus 2.2% (P < 0.0001) achieved ≥2-grade improvement at Day 14. As assessed by participants, 79.9% of onabotulinumtoxinA mITT participants versus 21.8% in the placebo group and 40.8% versus 3.9% (P < 0.0001) achieved ≥1- or ≥2-grade improvement, respectively, at Day 14. OnabotulinumtoxinA responder rates remained higher than placebo through Day 120, gradually declining over time. OnabotulinumtoxinA participants reported significantly higher satisfaction with treatment effect, lower bother from jawline and vertical neck bands, and lower psychosocial impact from PP than placebo at Day 14 (P < 0.0001). OnabotulinumtoxinA effectively improved self-perceived jawline definition and was well tolerated. CONCLUSIONS: OnabotulinumtoxinA was well tolerated and effective in improving moderate-to-severe PP, including neck bands and jawline definition.

"Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study".

BACKGROUND: With aging, repetitive contraction of the platysma leads to an increase in platysma prominence (PP) characterized by the accentuation of vertical neck bands and blunting of the jawline's contour. METHODS: This multicenter, double-blind, phase 2 study evaluated onabotulinumtoxinA (onabotA) treatment in adults with Moderate to Severe PP. Participants were randomized to receive 1 treatment of onabotA low dose (LD), onabotA high dose (HD), or placebo, and were followed for 4 months. Efficacy endpoints were the achievement of a ≥ 1-grade improvement on both the left and right sides at Day 14 at maximum contraction as assessed by the investigator (primary) or by participants (secondary) using validated scales. Safety was evaluated throughout. RESULTS: Participants in the modified intent-to-treat population (N = 164) had a mean age of 50 years; 95.1% were female and 93.9% were White. The primary endpoint was met for both onabotA groups, with investigator-assessed ≥ 1-grade improvement in 77.8% (LD) and 88.2% (HD) vs 12.0% (placebo) of participants on Day 14 (P < 0.0001 vs placebo). Based on participant self-assessment, 75.9% (LD) and 88.2% (HD) vs 18.0% (placebo) achieved ≥ 1-grade improvement on Day 14 (P < 0.0001 vs placebo). Most treatment-related adverse events (AEs) were procedure-related, transient, and mild in severity. The most frequent onabotA-related AE was neck muscle weakness, reported in the HD group. CONCLUSIONS: OnabotA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated.

It Is About Trust: Trust in Sources of Tobacco Health Information, Perceptions of Harm, and Use of E-Cigarettes.

INTRODUCTION: Recent research has highlighted disparities in people who perceive as trustworthy sources of e-cigarette health information. Research has yet to examine if trusting a particular source of information is associated with use of e-cigarettes or perceptions of e-cigarette harm. We use a nationally representative survey of American adults to address these gaps in knowledge. METHODS: This study used data from the Health Information National Trends Survey (N = 3738). Logistic regression models were used to calculate odds of ever using e-cigarettes and perceived health harm of e-cigarettes. Trust in seven different sources of e-cigarette health information served as the independent variables. Models accounted for confounders. RESULTS: Trusting religious organizations "a lot" as sources of e-cigarette health information was associated with lower odds of ever using e-cigarettes and with lower odds of perceiving e-cigarettes as less harmful than conventional cigarettes. Trusting e-cigarette companies "a lot" as sources of e-cigarette health information was associated with lower odds of viewing e-cigarettes as harmful to health. CONCLUSION: Trusting health information about e-cigarettes from sources in the medical or public health field was not associated with lower use of e-cigarettes or viewing e-cigarettes as more harmful. Trusting health information from e-cigarette companies yielded perceptions of e-cigarette harm that are consistent with messaging provided by these companies. IMPLICATIONS: As use of e-cigarettes continues to climb, leveraging different modes of health communication will be critical to both discourage e-cigarette use among never-smokers and, potentially, to encourage use of e-cigarettes as an option to achieve smoking cessation or reduce the harm of tobacco products. Our findings suggest that religious organizations may be helpful in communicating anti-e-cigarette messages.

The cost of screening esophageal varices: traditional endoscopy versus computed tomography.

OBJECTIVE: Under current guidelines, patients diagnosed with cirrhosis are to undergo initial and continued screening endoscopy for esophageal varices throughout the course of disease. Recent literature suggests that computed tomography (CT) of the abdomen is adequately sensitive for detecting grade 3 varices, those in need of immediate intervention. This study presents a cost comparison of traditional endoscopy versus CT of the abdomen. METHODS: Using TreeAge Pro software, a budget impact cost model was created for a hypothetical managed care organization covering 1 million lives over a 10-year period. Incidence figures for cirrhosis and the progression of esophageal varices were applied to the patient population. National Medicare reimbursement costs were used to compare screening with traditional endoscopy versus CT. Costs utilizing screening with combined endoscopy and CT were also examined. RESULTS: The results of comparing screening paradigms under a budget impact cost model results in an outcome measure termed "per-member, per-month" (PMPM) cost of implementing a new strategy. Computed tomography was the least expensive modality with an average 10-year cost per screened patient of $1097.30 and PMPM of $0.03. Endoscopy was the most expensive modality with an average 10-year cost per screened patient of $1464.89 and PMPM of $0.04. CONCLUSION: Computed tomography has been shown to be sensitive in detecting esophageal varices and now less costly to implement in screening. The cost of esophageal rupture in endoscopy and the less costly risk of contrast reaction as well as radiation exposure in CT of the abdomen should be considered when developing a screening paradigm.