A Double-Blind, Randomized Clinical Trial to Determine Effects of Increasing Doses and Dose-Response Relationship of IncobotulinumtoxinA in the Treatment of Glabellar Rhytids.

BACKGROUND: IncobotulinumtoxinA is an effective neuromodulator for treating glabellar rhytids. The relationship between dose and reduction in rhytid severity is well established. However, the effects of escalating doses on the treatment duration response are less understood. OBJECTIVES: The aim of this study was to assess the effects of increasing doses of incobotulinumtoxinA on the treatment duration for glabellar rhytids. METHODS: A randomized, double-blind, Phase IV study was conducted at a fully accredited, outpatient surgical facility. Subjects (31 female, 7 male) with moderate to severe glabellar rhytids were randomized to 1 of 3 incobotulinumtoxinA dose groups: 20, 60, or 100 U. Effect duration was determined by calculating the time to return to baseline for dynamic glabellar lines during maximal contraction. Follow-up was completed through 1 year, and adverse events were monitored. RESULTS: The median duration of effect was 120 days (95% confidence interval [CI] [90, 180 days]), 180 days (95% CI [180, 210 days]), and 270 days (95% CI [240, 330 days]) for the 20-, 60-, and 100-U groups, respectively. A Wald chi-square test from the Cox regression on the primary efficacy variable indicated a statistically significant effect of dose group on time to baseline (chi square = 54.63; df = 2; P < 0.001). Hazard ratios were HR = 0.21 (95% CI [0.10; 0.43] for the 60-U vs the 20-U group, and HR = 0.06 (95% CI [0.10; 0.43]) for the 100-U vs the 20-U group, indicating a statistically longer return to baseline for both the 60- and 100-U cohorts. CONCLUSIONS: There is a dose-dependent relationship between incobotulinumtoxinA and duration of effect in the glabella.

A Randomized, Blinded, Prospective Clinical Study Comparing Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers for the Treatment of Perioral Rhytids.

BACKGROUND: Perioral rhytids are a bothersome sign of aging for many patients. Although multiple treatments exist, choosing an optimal modality may be difficult considering that rhytids in this region are fine and the anatomy dynamic. OBJECTIVES: The authors sought to compare the efficacy and safety as well as patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance) in reducing superficial perioral rhytids. METHODS: The study was double-blinded, and 48 patients with moderate to severe superficial perioral rhytids were enrolled. Patients were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right or vice versa. Rhytid severity was measured by patients utilizing a linear analog scale, and by investigators utilizing a validated 5-point scale, for 180 days following treatment. RESULTS: Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL than CPM-HA and remained so at 180 days (P < .05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, and SP-HAL was associated with 1 postinflammatory nodule and 2 occurrences of Tyndall effect. CONCLUSIONS: Although both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect.