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.

Management of Patient Experience With ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat.

Background: ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was recently approved for submental fat (SMF) reduction in the United States (Kybella) and Canada (Belkyra). The pivotal trials supporting these approvals revealed that ATX-101 is associated with common injection-site treatment reactions consistent with its mechanism of action and administration procedure.

Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat. ATX-101 has been evaluated in a clinical development program that included 18 Phase 1 to 3 studies supporting the current indication.

ATX-101 for reduction of submental fat: A phase III randomized controlled trial.

Background: ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.

Objective: We sought to evaluate the efficacy and safety of ATX-101.

Methods: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo.

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

Background: ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction.

Objective: To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101.

Methods: Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo.

A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.

Objective: To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis.

Methods: This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle.

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.

Development and validation of a photographic scale for assessment of lip fullness.

Background: As lip augmentation becomes more popular, validated measures of lip fullness for quantification of outcomes are needed.

Objective: Develop a scale for rating lip fullness and establish its reliability and sensitivity for assessing clinically meaningful differences.

Methods: The initial Allergan Lip Fullness Scale (iLFS; a four-point photographic scale with verbal descriptions) was validated by eight physicians rating 55 live subjects during two rounds, conducted on one day.

Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial.

Background: This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.

Objective: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL).

Methods: This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306).

The impact of upper facial lines and psychological impact of crow's feet lines: content validation of the Facial Line Outcomes (FLO-11) Questionnaire.

Background: Treatments for upper facial lines (UFL), the most visible sign of aging, are of interest to patients and clinicians alike. Patient-reported outcomes (PROs) are valuable in evaluating the impact of such treatments; however, regulatory recommendations have stipulated that the patient perspective be central in developing these assessments.

Objectives: (1) To evaluate the content validity of the Facial Lines Outcomes Questionnaire, a PRO instrument developed to assess upper facial line impacts, according to the regulatory guidance of the United States Food and Drug Administration and (2) assess whether it adequately measures the psychological impacts associated with crow's feet lines (CFL) (lateral canthal lines) from the patient perspective.

Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial.

Background: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.

Objective: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL.

Methods: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223).

An interrater and intrarater reliability study of 3 photographic scales for the classification of perioral aesthetic features.

Background: Validated aesthetic rating scales for the perioral area provide objective evaluations for clinical trials and practice.

Objective: To confirm the reliability of 3 scales for evaluating dermal filler and neurotoxin treatments of the perioral area.

Materials And Methods: Three lip-specific photographic scales were developed from standardized 2-dimensional images to evaluate Perioral Lines at Rest (POL), Oral Commissures (OCS), and Perioral Lines at Maximum Contraction (POLM) severity scales.

Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study.

Background: Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of bimatoprost ophthalmic solution 0.

Juvederm ultra for lip enhancement: an open-label, multicenter study.

Background: Juvéderm Ultra injectable gel (Allergan, Inc, Irvine, California) is approved in the United States to treat moderate to severe wrinkles and folds, such as nasolabial folds. It is also used to enhance the appearance of the lips.

Objectives: The authors evaluated the safety and effectiveness of Juvéderm Ultra injectable gel for lip enhancement and assessed the utility of 3 new lip-specific effectiveness scales.

OnabotulinumtoxinA: a meta-analysis of duration of effect in the treatment of glabellar lines.

Background: Duration of effect of aesthetic treatments with botulinum toxin potentially influences subject satisfaction, treatment frequency, and annual costs, but quantitative outcomes for measuring duration of effect and correlations with subject satisfaction have yet to be fully elucidated.

Methods And Materials: Phase III clinical trials with similar designs were identified and their data pooled to ascertain duration of clinical effect of onabotulinumtoxinA in glabellar muscles. Duration was calculated using the Kaplan-Meier method for investigator-rated Facial Wrinkle scale (FWS) scores and subject global assessment (SGA) of glabellar lines.

Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study.

Background: Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes.

Objective: We sought to compare the safety and efficacy of once-daily bimatoprost 0.

Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials.

Background: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP) based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥12 months) were conducted; however, the aggregate safety profile of the six studies has not been reported.

Dose response with onabotulinumtoxinA for post-stroke spasticity: a pooled data analysis.

Clinical trials demonstrate that onabotulinumtoxinA reduces upper limb post-stroke spasticity, with therapeutic response influenced by injected dose. Individual studies provide limited insight regarding muscle group-specific dose-response relationships. Our objective was to characterize dose-response relationships between onabotulinumtoxinA and muscle tone in specific upper limb muscles.

Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers.

Many patients elect to have repeat treatments with hyaluronic acid dermal fillers to maintain wrinkle correction, but the clinical performance of these products after repeat treatments has not been formally assessed. The primary objective of this study was to evaluate the effectiveness of Juvéderm injectable gel (Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm 30) through 1 year after repeat treatment of nasolabial folds (NLFs) that were previously treated with Juvéderm or Zyplast 6-9 months prior to the repeat treatment. Upon completion of the pivotal IDE clinical trial for Juvéderm, five of the original 11 study sites were selected to participate in an extended follow-up evaluation, and a total of 80 subjects were enrolled.

Meta-analysis of neutralizing antibody conversion with onabotulinumtoxinA (BOTOX®) across multiple indications.

This meta-analysis evaluated the frequency of neutralizing antibody (nAb) conversion with onabotulinumtoxinA (BOTOX®; Allergan) across five studied indications. The analysis was based on large, controlled or prospective, open-label trials (durations 4 months to ≥2 years). Serum samples were analyzed for nAbs using the Mouse Protection Assay.

Effectiveness of Juvéderm Ultra Plus dermal filler in the treatment of severe nasolabial folds.

Background: With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with greater therapeutic power to correct aging changes will be in growing demand.

Methods: A multicenter, double-blind, randomized, within-subject, controlled study was conducted comparing Juvéderm Ultra Plus hyaluronic acid filler with bovine collagen.

Visual screening for malignant melanoma: a cost-effectiveness analysis.

Objective: To evaluate the cost-effectiveness of various melanoma screening strategies proposed in the United States.

Design: We developed a computer simulation Markov model to evaluate alternative melanoma screening strategies.

Participants: Hypothetical cohort of the general population and siblings of patients with melanoma.

Microdermabrasion: a review.

Microdermabrasion is used by clinicians and aestheticians worldwide to rejuvenate facial skin. The microdermabrator contains aluminum oxide or sodium chloride crystals that strike the skin and produce superficial trauma. It is theorized that the repetitive intraepidermal injury causes gradual improvement in damaged skin by stimulating fibroblast proliferation and collagen production, leading to new collagen deposition in the dermis.

The melanoma epidemic: res ipsa loquitur.

Many have debated whether or not we are in the midst of a melanoma epidemic. Some facts are clear and helpful to this debate, while others are less clear. The incidence and mortality of melanoma have increased over the last several decades, but the incidence has risen faster than the mortality.