ABSTRACT
BACKGROUND: Juvéderm Voluma XC (VYC-20L) is approved in the United States for correction of age-related volume loss in the midface region in adults. OBJECTIVE: To characterize the effects of VYC-20L in 3 midface subregions based on injection volumes. METHODS: In this single-blind controlled trial, subjects with midface volume deficit received VYC-20L in ≥1 of 3 facial subregions (zygomaticomalar, anteromedial cheek, and submalar), with touch-up treatment available 30 days later. Responders achieved ≥1-point improvement on the Mid-Face Volume Deficit Scale (MFVDS), analyzed by facial subregion and stratified by injection volume quartiles. Subject satisfaction and safety were assessed. RESULTS: The treatment arm comprised 235 subjects aged 35 to 65 years. Month 6 MFVDS responder rates were 75.5% for zygomaticomalar, 83.2% for anteromedial cheek, and 76.9% for submalar subregions. Higher responder rates were observed with increasing injection volume quartiles for each subregion. Similar median injection volumes (≈2.0 mL total) of VYC-20L provided correction durations of 15 to 24 months: 24 months for anteromedial cheek, 19 months for zygomaticomalar, and 15 months for submalar subregions. Subject satisfaction was high across injection volume quartiles. No unanticipated treatment-site adverse reactions occurred. CONCLUSION: VYC-20L is effective at restoring midface volume, with high subject satisfaction and an acceptable safety profile.
Subject(s)
Cosmetic Techniques , Dermatologic Agents/administration & dosage , Face , Hyaluronic Acid/administration & dosage , Skin Aging , Adult , Aged , Cosmetic Techniques/adverse effects , Dermatologic Agents/adverse effects , Female , Humans , Hyaluronic Acid/adverse effects , Male , Middle Aged , Patient Satisfaction , Single-Blind Method , Time FactorsABSTRACT
BACKGROUND: Little information exists on how facial aesthetic treatments are incorporated into aesthetic regimens. OBJECTIVE: Assess the evolution of facial aesthetic treatments in patients receiving long-term continuous onabotulinumtoxinA treatment. METHODS: This international retrospective chart review included patients with ≥5 years of continuous onabotulinumtoxinA treatments including ≥1 glabellar lines treatment/year. Charts were reviewed for facial areas treated, number of treatments, doses/treatment visit, concomitant aesthetic procedures, and onabotulinumtoxinA-related adverse events. RESULTS: Data were collected from 5,112 onabotulinumtoxinA treatment sessions for 194 patients over an average of 9.1 years. Dosing was relatively stable over time; however, interinjection intervals increased. Glabellar lines' treatment temporally preceded crow's feet lines and forehead lines' treatment. A majority of patients (85%) also received treatment with fillers. Cumulative increases in onabotulinumtoxinA treatments occurred over time and by facial area corresponding with increases in treatments with injectable fillers, energy-based devices, and prescription topical creams. The longer the patients were treated, the younger they perceived themselves to look. Rates of adverse events were low. CONCLUSION: OnabotulinumtoxinA treatment evolved over time, coinciding with growth of the facial aesthetics market. Additional treatment modalities were added as complements to onabotulinumtoxinA. Long-term continuous onabotulinumtoxinA injections are an important component of contemporary facial aesthetic treatment regimens.
Subject(s)
Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques/trends , Neuromuscular Agents/administration & dosage , Skin Aging/drug effects , Adult , Aged , Aged, 80 and over , Botulinum Toxins, Type A/adverse effects , Combined Modality Therapy/trends , Cross-Sectional Studies , Dermatologic Agents/therapeutic use , Drug Administration Schedule , Esthetics , Eye , Female , Forehead , Humans , Male , Middle Aged , Neuromuscular Agents/adverse effects , Patient Satisfaction , Retrospective Studies , Self Concept , Surveys and Questionnaires , Time FactorsABSTRACT
BACKGROUND: Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting. OBJECTIVE: To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations. MATERIALS AND METHODS: Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed. RESULTS: Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance. CONCLUSION: OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.
Subject(s)
Botulinum Toxins, Type A/therapeutic use , Neuromuscular Agents/therapeutic use , Patient Satisfaction , Self Concept , Skin Aging/drug effects , Adult , Double-Blind Method , Eye , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Treatment OutcomeABSTRACT
During mouse embryo implantation, trophoblast invasion is controlled in part by a balance of trophoblast-derived proteinases and uterine decidual proteinase inhibitors. Our work has focused on cystatin C, the secreted inhibitor of cathepsins B and L. We have previously shown that cystatin C is synthesized by the uterine decidua and localized to the cells in close contact with the trophoblast during implantation in vivo. In the work reported here we have established that decidualizing cultures show a similar upregulation of cystatin C. Using Northern and Western blotting and immunolocalization techniques both cystatin C mRNA and secreted protein increased with the morphological differentiation of stromal or decidual capsule cultures. In an effort to understand the regulation of cystatin C expression, decidual cells were analyzed under various culture conditions. Cystatin C expression was upregulated by increased cell density and by the presence of serum in the media. The growth factors TGF-beta(1) and EGF were found to induce cystatin C to levels comparable to serum stimulation. Co-culture with ectoplacental cones (EPCs) likewise induced expression and resulted in the localization of cystatin at the decidua:trophoblast interface. This work shows that decidualizing cultures are a good system to study cystatin C expression and that the expression is controlled in part by TGF-beta(1) and EGF signaling.