Publications by authors named "Beta Bowen"

Background: OnabotA is used to treat masseter muscle prominence (MMP).

Objective: To assess the safety and efficacy of OnabotA for MMP in a randomized study.

Methods: This 12-month, multicenter, double-blind, placebo-controlled, phase 2 study randomized adults (18-50 years of age) with marked/very marked bilateral MMP (≥4 on the Masseter Muscle Prominence Scale [MMPS]) to OnabotA (24, 48, 72, or 96 U) or placebo; retreatment occurred at day 180 if MMPS ≥4.

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Background: Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image.

Aims: To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF.

Methods: A prospective, open-label, interventional, single-site study enrolling 22- to 65-year-old participants rated as Grade 4 (extreme) on the Clinician-Rated SMF Rating Scale (CR-SMFRS).

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Background: ATX-101 is indicated for submental fat treatment.

Objective: Evaluate ATX-101 versus placebo for reducing submental fat.

Materials And Methods: Adults with unwanted submental fat across 6 global sites were randomized to ATX-101 (0.

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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).

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Background: ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF).

Objective: To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF.

Patients And Methods: Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo.

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Background: ATX-101 is approved for submental fat reduction.

Objective: To characterize the histological effect of ATX-101 injection into subcutaneous fat.

Methods: This Phase 1 open-label study enrolled 14 adults to receive injections of ATX-101 into abdominal fat at varying concentrations (0.

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Introduction: no previously published botulinum toxin type A cosmetic trials included both physician and subject measures of onset.

Objective: determine physician- and subject-reported onset of onabotulinumtoxinA.

Methods: Two-center open-label, 14-day study in toxin-naive female patients with moderate-to-severe glabellar lines (GL) treated with 20-U onabotulinumtoxinA.

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Background: OnabotulinumtoxinA for the treatment of facial lines is a widely used cosmetic medical procedure and, as such, the safety and tolerability profile is of interest to health care providers and patients. Based on data from individual studies that were conducted according to regulatory guidelines to provide adequate safety and efficacy data to support product licensure (registration studies), the overall benefit:risk profile of onabotulinumtoxinA for facial lines has been favorable.

Objective: Our objective was to increase statistical power through meta-analysis to detect treatment group differences in adverse event (AE) incidence that may not have been evident in individual registration studies.

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Objective: To examine the safety of botulinum toxin type A (BTX-A).

Design: Analysis of pooled data of 9 double-blind, placebo-controlled studies of patients with spasticity after stroke.

Setting: University hospitals and specialty rehabilitation centers in the United States.

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