OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.
Underweight status was an independent predictor for in-hospital mortality in our cohort of pediatric ECMO patients. Prospective studies evaluating the impact of metabolic state of children on ECMO should further define this relationship.
BACKGROUND
Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies.
OBJECTIVE
To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL).
MATERIALS AND METHODS
A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire.
RESULTS
The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated.
CONCLUSION
OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.
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