Does Increasing the Dose of Abobotulinumtoxina Impact the Duration of Effectiveness for the Treatment of Moderate to Severe Glabellar Lines?
Joseph, J.H.; Eaton, L.L.; Robinson, J.; Pontius, A.; Williams, E.F.
Journal of Drugs in Dermatology Jdd 15(12): 1544-1549
2016
ISSN/ISBN: 1545-9616 PMID: 29106437 Document Number: 17115
To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines. Investigator-initiated, prospective, multi-center, open-label study. This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex. Investigator and subject assessments of wrinkle severity at maximum frown and repose using 4-point scales and adverse events were conducted. Follow-up was monthly for up to 11 months. The median duration of response for all subjects, as assessed by the investigator, was 150 days (95% CI: 120, 180). The median duration of response was 165 days (95% CI: 90, 180) for subjects with Grade 2 (Moderate) wrinkles at baseline and 75 days (95% CI: 30, 120) for subjects with Grade 3 (Severe) wrinkles at baseline. Overall, 76.7% of subjects had a duration of ≥ 120 days. At the end of study (day 300) 9/16 (53%) of subjects who were Grade 3 at baseline still rated themselves as not returning to Grade 3, demonstrating ongoing improvement. Adverse events were mild and transient. There were no events of lid or brow ptosis. The 120 units of abobotulinumtoxinA were significantly effective in reducing glabellar lines in subjects with Grade 2 (Moderate) wrinkles at baseline for a longer duration than the reported 85 days in the FDA Phase III randomized, placebo-controlled clinical studies using a standard 50 unit dose. Subject satisfaction was high. There was no increase in the incidence of adverse events with this higher dose.
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