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Background: PURPOSE: Baseline characteristics in neurotoxin trials can affect perceived clinical efficacy depending on which outcomes are assessed. When glabellar line (GL) severity improvement is assessed on a 4-graded scale and a score of none or mild is used as responder definition, subjects who have moderate GLs at baseline must move at least one grade to be considered a treatment success, whereas subjects who start with severe GLs must move at least two grades; a one-grade improvement for those with severe GLs is considered failure even though the subjects moved the same distance on the scale.
BACKGROUND The perioral region is highly mobile and subject to multifactorial changes during aging. Resilient Hyaluronic Acid Redensity (RHA(R)), an RHA filler, was developed with the aim of optimizing outcomes in dynamic facial areas. OBJECTIVE This randomized, blinded, multicenter clinical study aimed to demonstrate superiority of RHA(R) over no-treatment control for correction of moderate-to-severe dynamic perioral rhytides. MATERIALS AND METHODS Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary scale (Perioral Rhytids Severity Rating Scale [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed their results with FACE-Q, a validated patient-reported outcome measure, and satisfaction scales. Safety was monitored throughout the study based on common treatment responses (CTRs) and adverse events (AEs). RESULTS The primary efficacy end point was achieved, with the treatment group showing statistically significant superiority over the control group at Week 8 (80.7% vs 7.8% responder rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 (study completion). Most AEs were CTRs after perioral injection of a dermal filler, and none was a clinically significant treatment-related AE. CONCLUSION Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.
Background Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). Aims Evaluation of subject-reported indicators of treatment efficacy, satisfaction, and psychological well-being with ABO dose escalation. Methods A Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject-assessed improvement in line severity of >= 1-grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE-Q (TM) appraisal of lines, psychological well-being and age, and subject satisfaction. Results The study included 399 subjects (88.2% were female). Respective responder rates (>= 1-grade improvement) with ABO 50-125 U doses ranged between 96.3%-100% at Week 4, 65.0%-67.9% at Week 24, and 33.8%-44.4% at Week 36. GAIS responder rate and FACE-Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well-being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. Conclusions A single ABO treatment (dosed at 50-125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well-being.
