Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials.

Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI 40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3).

Objectives: The aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups.

Injection techniques for midface volumization using soft tissue hyaluronic acid fillers designed for dynamic facial movement.

Volume loss of the face occurs over time; thus, volume enhancement of the midface can counteract the effects of aging. Hyaluronic acid (HA) fillers are often used for facial revolumization for a more youthful appearance due to their favorable outcomes and safety profiles. A patient-centric approach, in which dynamic facial expressions are considered, is needed for optimal aesthetic results.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

Background: 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.

Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.

Background: A global approach to facial rejuvenation involves multiple treatment modalities.

Objectives: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes.

Methods: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost.

Absorbable Suspension Sutures: Recommendations for Use in a Multimodal Nonsurgical Approach to Facial Rejuvenation.

Background: Absorbable suspension sutures are an effective nonsurgical modality for correction of ptosis and tissue repositioning in the face and neck. The PLLA/PLGA suture is entirely absorbable and has a dual effect in that it both lifts tissues and induces collagenesis, thereby restoring contour. In clinical practice, nonsurgical modalities are rarely used in isolation, and combination treatments with fillers, neuromodulators, lipolysis, and energy-based devices are common.

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.

Background: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines.

Objective: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines.

Methods: Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks.

ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study.

BACKGROUND: ATX-101 (deoxycholic acid) causes adipocytolysis when injected into subcutaneous fat. OBJECTIVE: Evaluate the long-term safety and efficacy of ATX-101 for submental fat (SMF) reduction. METHODS: Adults (N=165) with moderate-to-extreme SMF received ≤6 treatments of open-label ATX-101 (2 mg/cm2) and were evaluated up to 12 months after last treatment.

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study.

Background: Injectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics.

Aims: The efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic wrinkles.

Novel Tretinoin 0.05% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in a Hispanic Population.

Background: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns.

Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study.

Background: The impact of facial aesthetic treatments not only enhances physical appearance but also psychological well-being. Accordingly, patient-reported outcomes are increasingly utilized as an important measure of treatment success. Observer-reported outcomes are a relevant yet often overlooked measure of treatment benefit.

Expert Consensus on Achieving Optimal Outcomes With Absorbable Suspension Suture Technology for Tissue Repositioning and Facial Recontouring.

A complete approach to facial rejuvenation includes restoration of the skin's surface, relaxation of muscles that contribute to hyperkinetic movement, revolumization, and repositioning/recontouring of descended tissues and fat pads. After receiving 510(k) clearance from the US Food and Drug Administration (FDA) in 2015, the Silhouette InstaLift™ absorbable suspension suture became the only available non-surgical technique for repositioning of facial tissue. In January 2017, a consensus paper presented a review of the literature on the efficacy and safety of absorbable suspension sutures and provided information on treatment procedures.

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

Background: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine.

Objectives: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement.

Methods: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.

Background: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas.

Objectives: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments.

Methods: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

Background: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency.

Objective: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program.

Methods: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs.

A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: Injection Techniques and Treatment Characteristics From the HARMONY Study.

Background: The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures.

Objective: Provide details of this treatment approach and describe investigators' experiences and recommendations based on this study.

Methods: This multicenter, 4-month study evaluated subject satisfaction with and psychological impact of combined treatment with VYC-20L (Juvéderm Voluma XC), HYC-24L (Juvéderm Ultra XC), HYC-24L+ (Juvéderm Ultra Plus XC), onabotulinumtoxinA (Botox), and bimatoprost 0.

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

Importance: Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date.

Objective: To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers.

Design, Setting, And Participants: A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists.

Effects of a facial cream containing the minor alkaloid anatabine on improving the appearance of the skin in mild to moderate rosacea: an open-label case series study.

Background: Current medical and scientific research indicates that rosacea, a chronic and often debilitating skin condition that primarily affects the central face, may be caused by an overactive or excessive inflammatory immune response. Regardless of etiology, the accompanying redness and inflammation is unsightly and difficult for the patient. Anatabine is an alkaloid from the plant family Solanaceae that has been shown in several preclinical studies to modulate proinflammatory signaling pathways.

A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvéderm injectable gel with and without lidocaine.

Introduction: Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm((R)) injectable gel with lidocaine (denoted as JUV + L) to commercially-available Juvéderm((R)) injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction.

Methods: Subjects received randomized treatment with the lidocaine filler in one NLF and the filler without lidocaine in the other NLF.

Fluorouracil 5% and 0.5% creams for the treatment of actinic keratosis: equivalent efficacy with a lower concentration and more convenient dosing schedule.

Several formulations and concentrations of topical fluorouracil have received US Food and Drug Administration (FDA) approval for the treatment of actinic keratosis (AK). The most commonly used are the fluorouracil 5% and 0.5% creams.

Treatment options in the management of actinic keratosis.

Successful treatment of actinic keratosis (AK) requires an understanding of available treatments and matching those treatments with each patient's disease severity, lifestyle, insurance coverage, and primary reason for the physician visit. Cryotherapy and other destructive strategies are optimal for hypertrophic and clearly delineated lesions, but they may not address subclinical lesions and are associated with risk of scarring, infection, and pigmentary changes. Topical therapies such as the fluorouracil creams are appropriate for treating large regions of affected skin but are associated with application-site irritation.

Matching patients with therapy.

Multiple options are available for the treatment of actinic keratosis (AK). Each therapy has its own idiosyncrasies and risks, and not every modality is appropriate for every patient. Physician experience and clinical factors such as patient demographics, concerns, reason for the office visit, and lifestyle, as well as the pros and cons of each treatment modality, must be considered when developing customized rational treatment programs.