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

Z Paul Lorenc, Jeffrey M Adelglass, Rui L Avelar, Leslie Baumann, Kenneth R Beer, Joel L Cohen, Sue Ellen Cox, Steven H Dayan, Jeffrey S Dover, Jeanine B Downie, Zoe Diana Draelos, Mitchel P Goldman, John E Gross, John H Joseph, Joely Kaufman-Janette, Ronald L Moy, Mark Nestor, Joel Schlessinger, Stacy R Smith, Robert A Weiss, Z Paul Lorenc, Jeffrey M Adelglass, Rui L Avelar, Leslie Baumann, Kenneth R Beer, Joel L Cohen, Sue Ellen Cox, Steven H Dayan, Jeffrey S Dover, Jeanine B Downie, Zoe Diana Draelos, Mitchel P Goldman, John E Gross, John H Joseph, Joely Kaufman-Janette, Ronald L Moy, Mark Nestor, Joel Schlessinger, Stacy R Smith, Robert A Weiss

Abstract

Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.

Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.

Methods: 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.

Results: 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.

Conclusions: 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.

© 2021 The Aesthetic Society.

Figures

Figure 1.
Figure 1.
Treatment flowchart. Highlights of the study design included: adverse event assessment at each visit. Dose interval, ≥3 months. Monthly visits after day 90 for ineligible patient to assess for repeat injection eligibility. During repeat injection phase, day 2 and day 14 follow-up were conducted by phone and included a directed questionnaire. No new treatment was offered after day 330. aAt maximum frown, by investigator assessment. GLS, Glabellar Line Scale.
Figure 2.
Figure 2.
Disposition of all patients: safety and response-evaluable populations. The safety population was all patients who received at least 1 dose of prabotulinumtoxinA, and the response-evaluable population was all patients who received at least 1 dose of prabotulinumtoxinA on day 0 and had at least 1 post-baseline investigator or patient assessment. IA, investigator assessment; PA, patient assessment.
Figure 3.
Figure 3.
Photographs of glabellar lines at maximum frown at each of baseline (A), day 2 (B), day 7 (C), day 14 (D), day 30 (E), day 90 (F), day 120 (G), and day 150 (H) following initial treatment with 20 U prabotulinumtoxinA. This representative patient was a 48-year-old White female with Fitzpatrick skin type II and severe glabellar lines at maximum frown at baseline. She received 2 retreatments: the first at 5 months (ie, on day 150) and the second at 9 months (ie, on day 270) post baseline.
Figure 4.
Figure 4.
Percentage of patients with a decrease from baseline of ≥1 point on the Glabellar Line Scale at maximum frown by treatment at select visits: response-evaluable population. Efficacy assessments were not performed at repeat treatments D2 or D14. On and after day 90, patients were eligible for a repeat treatment if their Glabellar Line Scale score was ≥2 at maximum frown as judged by the investigator. If a patient did not have a Glabellar Line Scale score ≥2, they were followed monthly until eligible for repeat treatment or until the study ended on day 365. D, day; IT, initial treatment; RT, repeat treatment.
Figure 5.
Figure 5.
Percentage of patients with a positive response (improved/much improved) on the Global Aesthetic Improvement Scale by treatment at select visits: response-evaluable population. Efficacy assessments were not performed at repeat treatments D2 or D14. D, day; IT, initial treatment; RT, repeat treatment.
Figure 6.
Figure 6.
Percentage of patients with a positive response (satisfied/very satisfied) on the patient satisfaction scale by treatment at select visits: response-evaluable population. Efficacy assessments were not performed at repeat treatments D2 or D14. D, day; IT, initial treatment; RT, repeat treatment.

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Source: PubMed

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