Conor J. Gallagher

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. Responders were determined according to FWS score at maximum contraction and at repose 30 days after injection. RESULTS Data from four trials with 621 onabotulinumtoxinA‐treated (20 U) subjects were analyzed, 523 of these (84.2%) were identified as day‐30 responders on the FWS at maximum contraction. Pooled median duration of effect for day‐30 responders was 120 days for FWS at maximum contraction and 131 days for FWS at repose. Higher day 30 SGA scores were correlated with a greater duration of effect on dynamic, but not static lines. CONCLUSION Treatment of glabellar lines with 20 U of onabotulinumtoxinA resulted in sustained clinical benefit for 4 months in more than 50% of responders; subject satisfaction increased with duration of effect.

Heterogeneity of crow's feet line patterns in clinical trial subjects.

BACKGROUND Patterns of crows feet lines (CFLs) vary among individuals. OBJECTIVE To characterize distribution and predictors of CFL patterns. METHODS Patterns of CFLs (full fan, lower fan, central fan, and upper fan) were evaluated at maximum smile and at rest from photographs of subjects with moderate-to-severe CFLs. Relationships between CFL pattern and severity, age, gender, and subject-reported outcomes were explored. RESULTS Evaluations of 2,699 photographs from 1,392 subjects were conducted; 1,389 and 1,310 had evaluable CFL patterns at maximum smile and at rest, respectively. Lower-fan, central-fan, and full-fan patterns were identified in 28.4% to 34.7% at maximum smile and 27.7% to 33.9% at rest; upper fan was found in ∼5%. The pattern distribution of CFLs demonstrated a relationship to baseline CFL severity, age, and gender; full-fan and lower-fan patterns were more common in severe versus moderate CFL at maximum smile; full fan increased with age. Lower fan was more common in males. Subjects with full fan at maximum smile were most dissatisfied with their appearance and perceived themselves to look older versus other patterns. CONCLUSION Baseline CFL severity, age, and gender may predict fan pattern. Patterns may progress with age from central to lower fan or full fan. Pattern heterogeneity of CFLs suggests that tailored treatment may be warranted.

Facial Treatment Preferences Among Aesthetically Oriented Men.

BACKGROUND There is a paucity of data describing male attitudes toward age-related changes to their facial features and associated preferences for prioritizing treatment. METHODS Injectable-naive but aesthetically oriented men aged 30 to 65 participated in an online study (N = 600). Respondents indicated how concerned they were by the appearance of 15 age-related facial features, and the Maximum Difference scaling system was used to explore which features were most likely to be prioritized for treatment. The correlation between the features of most concern and the areas of treatment priority was assessed. Other aspects regarding the male perspective on aesthetic procedures, such as awareness, motivating factors, and barriers, also were explored. RESULTS Crows feet and tear troughs were rated as the most likely to be treated first (80% of first preferences) followed by forehead lines (74%), double chin (70%), and glabellar lines (60%). The areas of most concern in order were tear troughs, double chin, crows feet, and forehead lines. There was a strong correlation between the features of most concern and the areas of treatment priority (r2 = 0.81). CONCLUSION The periorbital areas, in particular crows feet and tear troughs, are of most concern and likely to be prioritized for treatment among aesthetically oriented men.

Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure.

BACKGROUND Patient satisfaction with treatment is an important outcome in facial aesthetic medicine. OBJECTIVE To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crows feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ). METHODS In this randomized double-blind study, subjects with moderate/severe GL and CFL received onabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale). RESULTS Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p < .001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p < .001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively. CONCLUSION High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.

Multicentre, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines

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Duration of Clinical Efficacy of OnabotulinumtoxinA in Crow's Feet Lines: Results from Two Multicenter, Randomized, Controlled Trials.

BACKGROUND Duration of esthetic treatments may contribute to subject satisfaction. OBJECTIVE Describe response duration with onabotulinumtoxinA in crows feet lines (CFL) and the association of duration with perception of improvement. METHODS Subjects from 2 double-blind, placebo-controlled trials received onabotulinumtoxinA 24 U in CFL; Study 2 subjects could also receive 20 U in glabella. At Day 30, responders achieved ≥1-grade improvement in Facial Wrinkle Scale (FWS) scores. Median duration of effect for responders and for responders stratified by Subjects Global Assessment of Change in CFL (SGA-CFL) was determined. RESULTS Of 1,362 subjects, 833 received onabotulinumtoxinA. In Study 2, 305 subjects also received 20 U in glabella. In Study 1 (150-day follow-up), per investigator and subject assessments, respectively, median response duration was 125 and 144 days for dynamic lines and 137 and 148 days for static lines. Median response duration for dynamic and static lines in Study 2 (120-day follow-up) was 119 to 121 days per investigator and subject assessments. Subjects reporting greater improvement on the SGA-CFL tended to have a longer duration of response on investigator FWS scores at maximum smile. CONCLUSION Response duration with onabotulinumtoxinA in CFL was ≥4 months. Subject perception of CFL improvement may be associated with response duration.

The South American Glabellar Experience Study (SAGE)A Multicenter Retrospective Analysis of Real-World Treatment Patterns Following the Introduction of IncobotulinumtoxinA in Argentina

BACKGROUND IncobotulinumtoxinA was approved in Argentina in 2007 for the treatment of moderate to severe glabellar lines. OBJECTIVE The authors evaluate real-world changes in facial aesthetic treatment patterns and patient satisfaction following the introduction of incobotulinumtoxinA in Argentina. METHODS This multicenter, retrospective chart review conducted in Argentina included women who had received at least 2 treatment cycles of onabotulinumtoxinA (Allergan, Irvine, California) for glabellar lines (period 1) prior to switching to incobotulinumtoxinA (Merz Pharma, GmbH, Frankfurt, Germany (period 2). Subjects were given the option to continue with incobotulinumtoxinA treatments (captured in period 2) or switch back to onabotulinumtoxinA (documented as period 3). Medical records were reviewed for demographics, dosing, reason for switching between products, treatment satisfaction, and interval between injection cycles. RESULTS One hundred ten women were enrolled and collectively received 662 treatment cycles with botulinum toxin. Subjects were switched to incobotulinumtoxinA at unit doses that were numerically and statistically similar to the onabotulinumtoxinA doses they received in period 1. Most subjects (92%) initially switched to incobotulinumtoxinA because of lower cost. Ninety-two subjects (84%) switched back to onabotulinumtoxinA in period 3, most commonly due to insufficient duration of effect with incobotulinumtoxinA (61/92; 66%). Subjects reported satisfaction with treatment in >90% of their onabotulinumtoxinA visits and in 34% of their incobotulinumtoxinA visits. Median interinjection intervals with onabotulinumtoxinA were 180.3 days (period 1) and 176.9 days (period 3) and 144.3 days with incobotulinumtoxinA in period 2. CONCLUSIONS In this real-world setting, subjects did not appear to perceive the same facial aesthetic benefits from incobotulinumtoxinA as onabotulinumtoxinA when the products were administered at comparable doses.

Signs of Facial Aging in Men in a Diverse, Multinational Study: Timing and Preventive Behaviors

BACKGROUND Men are a growing patient population in aesthetic medicine and are increasingly seeking minimally invasive cosmetic procedures. OBJECTIVE To examine differences in the timing of facial aging and in the prevalence of preventive facial aging behaviors in men by race/ethnicity. METHODS Men aged 18 to 75 years in the United States, Canada, United Kingdom, and Australia rated their features using photonumeric rating scales for 10 facial aging characteristics. Impact of race/ethnicity (Caucasian, black, Asian, Hispanic) on severity of each feature was assessed. Subjects also reported the frequency of dermatologic facial product use. RESULTS The study included 819 men. Glabellar lines, crows feet lines, and nasolabial folds showed the greatest change with age. Caucasian men reported more severe signs of aging and earlier onset, by 10 to 20 years, compared with Asian, Hispanic, and, particularly, black men. In all racial/ethnic groups, most men did not regularly engage in basic, antiaging preventive behaviors, such as use of sunscreen. CONCLUSION Findings from this study conducted in a globally diverse sample may guide clinical discussions with men about the prevention and treatment of signs of facial aging, to help men of all races/ethnicities achieve their desired aesthetic outcomes.

HYC-24L Demonstrates Greater Effectiveness With Less Pain Than CPM-22.5 for Treatment of Perioral Lines in a Randomized Controlled Trial.

OBJECTIVE This trial compares the effectiveness and safety of HYC-24L (Juvéderm Ultra XC; Allergan plc, Dublin, Ireland) (24 mg/mL of hyaluronic acid, 0.3% lidocaine) and CPM-22.5 (Belotero Balance; Merz Aesthetics, Raleigh, NC) (22.5 mg/mL of hyaluronic acid) for the treatment of perioral lines. MATERIALS AND METHODS Men and women aged 35 years or older with moderate-to-severe perioral lines were recruited for this randomized controlled, rater-blinded, 2-arm trial. The primary endpoint was a comparison of rater-assessed responder rates by the validated 4-point Perioral Lines Severity Scale at Month 6; responders were those who showed a ≥1 point improvement. A secondary endpoint was subject-assessed change in perioral lines measured by the Global Assessment of Change Scale. RESULTS A total of 136 subjects received treatment and 132 completed the trial (mean age: 58 ± 8 years). Total volume injected was 1.18 mL (HYC-24L) and 1.32 mL (CPM-22.5). At Month 6, a significantly greater proportion of HYC-24L subjects responded to treatment (87%) than CPM-22.5 subjects (72%) (p < .04). At all time points, HYC-24L subjects reported significantly greater improvement in their perioral lines than CPM-22.5 subjects, with the greatest difference at Month 6. No unexpected adverse events occurred. CONCLUSION HYC-24L subjects showed a higher response rate and a greater improvement in their perioral lines than CPM-22.5 subjects for up to 6 months.

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. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crows feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. Results Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. Conclusions Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance. Level of Evidence 4