IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.

BACKGROUND: In clinical practice, different upper facial areas are commonly treated together. OBJECTIVE: To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period. MATERIALS AND METHODS: In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores. RESULTS: A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection. CONCLUSION: IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

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 crow's 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 Subject's 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.

Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial.

BACKGROUND: This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA. OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL. METHODS: This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, and safety/adverse events (AEs) were evaluated. RESULTS: All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations. CONCLUSION: Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.