Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines
Subject satisfaction demonstrated for two on-label injection volumes of abobotulinumtoxinA (ABO) when used to treat moderate-to-severe glabellar lines
Presenters: Cohen J1, Kaufman J2, Peredo M3, Jonas B4, Nogueira A4, Mashburn J4
Affiliations: 1Director of AboutSkin Dermatology and DermSurgery, Greenwood Village and Lone Tree, CO, Associate Clinical Professor, Department of Dermatology, University of Colorado, CO, and Assistant Clinical Professor, Department of Dermatology, University of California Irvine; 2Skin Associates of South Florida, Skin Research Institute, Coral Gables, FL; 3Marina I. Peredo, MD, Smithtown, NY; 4Galderma Laboratories, L.P., Fort Worth, TX
Background/Objective: In the United States (US), glabellar lines (GLs) are most often treated with botulinumtoxin type A (BoNT-A), and satisfaction with treatment is typically measured using patient-reported outcomes. Dysport (abobotulinumtoxinA [ABO]) is approved in the United States for the treatment of GLs and can be injected at two different injection volumes—0.05mL and 0.08mL. This was a multicenter, randomized, subject- and evaluator-blinded study to evaluate the safety, efficacy, and subject satisfaction of two on-label injection volumes, 0.05mL/injection (Group A) and 0.08mL/injection (Group B), for the treatment of GLs. This report focuses on the subject satisfaction health-related quality of life aspects of the study.
Methods: Subjects with moderate-to-severe GLs at maximum frown were treated with ABO. Subjects were randomized to receive either 0.05mL/injection (Group A) or 0.08mL/injection (Group B), per the approved US label (5 injection points in the glabella area totaling 50U [10U at each injection site] for 1 treatment session). Subjects were given one treatment, then followed for up to four months. Subject assessments were completed before and after treatment.
Results: At 30 days posttreatment, the majority of subjects reported they were satisfied with how attractive they looked (86.7% for Group A, 76.7% for Group B), compared to baseline pretreatment, 20.0 and 36.7 percent, respectively. Subjects also felt more confident after either treatment (90.0% and 80.0% at Day 30, Group A and B, respectively) compared to baseline, 33.3 and 33.3 percent, respectively. At Day 30, subjects also reported an increase in psychological well-being (mean change from baseline 29.5 [P<0.0001] for Group A and 25.0 [P<0.0001] for Group B), being less bothered by their GLs (mean change from baseline 52.2 [P<0.0001] for Group A and 45.7 [P<.0001] for Group B), and looking four years younger than their current age compared to baseline (mean change from baseline -4.4 [P<0.0001] for Group A and -4.3 [P<0.0001] for Group B). These results were mostly maintained through 120 days posttreatment. There were no significant differences between treatment groups.
Conclusion: Subjects treated with two on-label injection volumes of ABO for moderate-to-severe GLs reported high subject satisfaction and increased psychological well-being through Day 120.
Funding: Galderma Laboratories, L.P.
