Grunebaum, Lisa

BACKGROUND RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A. OBJECTIVE Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL). METHODS Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported. RESULTS Month 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo). CONCLUSION RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated.

BACKGROUND The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HARR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION HARR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.

AbstractBackgroundHyaluronic acid fillers have been studied extensively for facial wrinkles; however, their efficacy for atrophic facial scars has yet to be analyzed in a prospective placebo‐controlled study.ObjectiveTo analyze the efficacy and safety of a hyaluronic acid filler for atrophic facial scars.Methods & MaterialsFifteen subjects were randomized to receive up to 1 ml of VYC‐17.5 L on one cheek and up to 1 ml of saline on the other side, with an optional touch‐up treatment. Subjects were graded by a live blind evaluator using the Quantitative Global Scarring Grading System (QGSGS) (J Cosmet Dermatol. 2006;5:48), the Global Aesthetic Improvement Scale (GAIS), and Canfield photo‐analysis.ResultsAccording to the blind evaluator, there was a significant reduction 90 days after the last treatment on the QGSGS for VYC‐17.5L compared with saline (−6.6 VYC‐17.5L vs −1.7 saline [t(28) = −4.3196,p = 0.008]). There was a smaller, but still significant reduction on the QGSGS for saline alone (10.4 to 8.6 [t(14) = −3.453,p = 0.004]). In addition, 93% (13/14) of subjects chose VYC‐17.5L over saline treatment and reported an improvement on the GAIS. There were no serious side effects and all minor side effects resolved by Day 30.ConclusionVYC‐17.5L achieved significant improvements in rolling atrophic scars as compared to saline, though saline also had modest improvements.

BACKGROUND Hyaluronic acid (HA) fillers have been studied extensively on the face; however, their safety and efficacy on the neck has not yet been evaluated in a prospective trial in the United States. OBJECTIVE Analyze the efficacy and safety of a HA filler for static horizontal neck rhytides using either a cannula or needle. MATERIALS AND METHODS Twenty-six subjects were randomized to receive up to 1 mL of the HA filler Restylane Refyne (HARR, n = 20) or saline (n = 6) using a cannula on one side and a needle on the other with optional repeat treatment. Subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale. RESULTS A significant improvement 30 days after the last treatment was achieved on the Transverse Neck Line Scale when comparing HARR with saline according to the blind evaluator, subjects, and investigator without any significant side effects. In addition, the blind evaluator, subjects, and investigator rated the side of the neck injected with a needle as having significantly greater improvement than the cannula. CONCLUSION The hyaluronic acid filler, Restylane Refyne, achieved significant improvement in static horizontal neck rhytides using either a cannula or needle without any serious side effects, although the needle was more effective.