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- Title
The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.
- Authors
Lorenc, Z Paul; Adelglass, Jeffrey M; Avelar, Rui L; Baumann, Leslie; Beer, Kenneth R; Cohen, Joel L; Cox, Sue Ellen; Dayan, Steven H; Dover, Jeffrey S; Downie, Jeanine B; Draelos, Zoe Diana; Goldman, Mitchel P; Gross, John E; Joseph, John H; Kaufman-Janette, Joely; Moy, Ronald L; Nestor, Mark; Schlessinger, Joel; Smith, Stacy R; Weiss, Robert A
- Abstract
<bold>Background: </bold>PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.<bold>Objectives: </bold>The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.<bold>Methods: </bold>This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study.<bold>Results: </bold>The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed.<bold>Conclusions: </bold>The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.<bold>Level Of Evidence:2: </bold>
- Subjects
BLEPHAROPTOSIS; BOTULINUM toxin; RESEARCH; MUSCLE relaxants; CLINICAL trials; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; FACE; COMPARATIVE studies; SKIN aging; BLIND experiment; RESEARCH funding
- Publication
Aesthetic Surgery Journal, 2021, Vol 41, Issue 12, p1423
- ISSN
1090-820X
- Publication type
journal article
- DOI
10.1093/asj/sjaa382