Deliberations of the Safety Task Force: Risk factors and treatment of adverse events associated with aesthetic injectables.

Background: The growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.

Aims: The inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.

AI assistance in aesthetic medicine-A consensus on objective medical standards.

Background: Aesthetic medicine has traditionally relied on clinical scales for the objective assessment of baseline appearance and treatment outcomes. However, the scales focus on limited aesthetic areas mostly and subjective interpretation inherent in these scales can lead to variability, which undermines standardization efforts.

Objective: The consensus meeting aimed to establish guidelines for AI application in aesthetic medicine.

Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.

Background: Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition.

Objective: To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs).

Materials And Methods: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months.

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.

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.

International Consensus Recommendations on the Aesthetic Usage of Ready-to-Use AbobotulinumtoxinA (Alluzience).

Alluzience (abobotulinumtoxinA RTU; Ipsen, Paris, France and Galderma SA, Lausanne, Switzerland) is the first ready-to-use (RTU) botulinum toxin type A liquid solution approved for the treatment of glabellar lines in Europe. In this article, the authors provide consensus recommendations on the aesthetic usage of abobotulinumtoxinA RTU. Members of the International Board on Alluzience convened to develop consensus on the treatment of glabellar lines as well as other facial wrinkles based on their own extensive experience.

Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study.

Background: Hyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation.

Objectives: This postmarket investigation evaluated the long-term performance and safety of and patient satisfaction with Princess VOLUME PLUS Lidocaine (PVPL; now Saypha VOLUME PLUS Lidocaine) for the correction of midface volume deficit (MVD).

Methods: This was an open-label, prospective, interventional, multicenter, noncomparative, postapproval study of 91 patients with moderate or severe MVD (grade 2 or 3 on the 5-point Midface Volume Deficit Severity Scale, or MVDSS).

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

Background: Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited.

Objectives: The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines.

Methods: Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study.

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.

Background: To further explore clinical trial results indicating increasing doses of botulinum toxin A prolong duration of effect, a 2-stage, phase 2, randomized, double-blind study investigated the duration of effect and safety of incobotulinumtoxinA (INCO; Xeomin®, Bocouture®) doses higher than the US Food and Drug Administration-approved 20 units (U) for glabellar frown lines (GFL). The stage 1 primary efficacy and safety results were reported previously. Here, we report the results of the final analysis (stage 1 and 2), including primary and secondary efficacy and safety endpoints.

IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines.

Background: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here.

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study.

In aesthetic practice, wrinkles in the upper face are commonly treated with repeat-dose injections. The objective of this study was to investigate the safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the combined treatment of moder-ate to severe upper facial lines (UFL) [glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)]. Healthy subjects (≥18 years) with moderate to severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contrac-tion were administered 54 to 64 U of incobotulinumtoxinA (GFL, 20 U; HFL, 10 to 20 U; LPL, 24 U) in up to four, 120-day treatment cycles.

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.

Background: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.

Objectives: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.

Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles: Results of an 18-Month, Randomized Controlled Trial Versus Already Available Comparators.

Background: Three new hyaluronic acid (HA)-based fillers made of long chains crosslinked with reduced amounts of 1,4-butanediol diglycidyl ether (BDDE) were developed for the treatment of dynamic facial areas. Their resilience and increased stretching ability were optimized to ease injectors' practice and provide patients with most natural aesthetic results.

Objective: This study aimed at evaluating the efficacy, durability, and safety of these resilient HA fillers versus commercially available comparator gels.

Validation of a Photonumeric Assessment Scale for Grading the Slope of the Asian Forehead.

Background: As the number of aesthetic treatments has grown, so have the number of photonumeric assessment scales used to compare the effectiveness of these aesthetic treatments in specific anatomical areas; however, these are primarily based on Caucasian features.

Objective: To assess the validity of the first aesthetic scale for assessing the slope of the Asian forehead. A secondary objective was to correlate this scale with subject demographics and baseline characteristics.

A Validated Assessment Scale for Asian Chin Projection.

Background: As the number of different aesthetic treatments increase, numerous photonumeric assessment scales have been developed and validated to measure the effectiveness of these new treatments and techniques. Photonumeric rating scales have been developed to objectively assess improvements in anatomical areas; however, these have been based on the features of Caucasian patients.

Objective: To develop and validate a Chin Projection Scale for use in the female Asian patient population.

Validated Assessment Scales for the Female Asian Calf.

Background: Clinical photonumeric scales have been developed and validated to objectively measure the effectiveness of aesthetic treatments in specific anatomical areas; however, these are based on the typical features of Caucasian patients. No clinical scale for Asian calf appearance currently exists.

Objective: To develop and validate a calf assessment scale for use in the female Asian patient population.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA 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 efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines.

Methods: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study.

Liquid Formulation of AbobotulinumtoxinA: A 6-Month, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of a Single Treatment, Ready-to-Use Toxin for Moderate-to-Severe Glabellar Lines.

Background: Safety and efficacy of botulinum toxin A for glabellar line (GL) treatment are well established. Currently approved formulations require reconstitution before injection.

Objectives: The authors sought to assess 6-month efficacy, safety, and patient satisfaction of new ready-to-use abobotulinumtoxinA solution for injection (ASI) in patients with moderate-to-severe GL at maximum frown.

Update of the S1 guidelines on the definition and treatment of primary hyperhidrosis.

Focal hyperhidrosis can have a considerable impact on social and occupational activities and be associated with significant impairment in quality of life. Primary (idiopathic) hyperhidrosis is neither caused by systemic disorders nor by external factors. It usually occurs in areas characterized by a high density of sweat glands such as the axillae and hands.

S3 Guideline for the treatment of psoriasis vulgaris, update - Short version part 2 - Special patient populations and treatment situations.

The German guideline for the treatment of psoriasis vulgaris was updated using GRADE methodology. The guideline is based on a systematic literature review completed on December 1, 2016, and on a formal consensus and approval process. The second part of this short version of the guideline covers the following special patient populations and treatment situations: tuberculosis screening before and during psoriasis treatment, choice of psoriasis treatment for individuals wishing to have children, as well as during pregnancy and breast-feeding, and patients with joint involvement and vaccinations.

S3-Leitlinie zur Therapie der Psoriasis vulgaris Update - Kurzfassung Teil 2 - Besondere Patientengruppen und spezielle Behandlungssituationen.

Die deutsche Psoriasis-Leitlinie zur Behandlung der Psoriasis vulgaris wurde unter Verwendung der GRADE-Methodik aktualisiert. Die Leitlinie wurde aufbauend auf einer systematischen Literaturrecherche (letzte Update-Recherche am 01.12.