Objectives: AbobotulinumtoxinA (ABO) is approved for glabellar line (GL) treatment using a dose of 50U. Subject satisfaction with GL treatment using higher ABO doses up to 125U vs placebo was evaluated as part of a Phase 2 study. The primary endpoint was Month 1 composite response, defined as a ≥2-grade GL severity scale (GLSS) improvement and a GLSS score of 0 or 1 assessed by both investigator and subject.
Introduction: - AbobotulinumtoxinA (ABO) is a botulinum toxin type A approved for use in glabellar line treatment using a dose of 50 U.
- Evaluation of subject satisfaction with ABO treatment for moderate-to-severe glabellar lines was undertaken as part of a Phase 2 study of single doses of ABO of 50 U, 75 U, 100 U or 125 U versus placebo (Table 1).
Materials / method: In this 9-month, double-blind study (NCT03736928), subjects received an ABO dose of 50U, 75U, 100U, or 125U, or placebo. Assessments included a subject satisfaction questionnaire, 3 FACE-Q scales (Psychological Function, Appraisal of Lines, and Perceived Age), GLSS at maximum frown, and safety. Time to return to baseline GLSS score was assessed concurrently on both investigator and subject scales.
Results: Around 80 subjects were evaluated per group. Subject satisfaction was high after treatment, >90% were satisfied with their appearance and agreed that they looked natural and appeared refreshed at Month 1. Subjects’ well-being improved, and they were less bothered about their GL and perceived themselves as younger up to Month 9. At Month 9, 18% (50U), 26% (75U), 35% (100U), 31% (125U) retained a ≥1-grade improvement (investigator GLSS). The median time to return to baseline GLSS scores was 226, 240, 252, and 256 days, respectively. Treatment was generally safe across all doses.
Conclusion: ABO was efficacious and well-tolerated across all doses from 50U to 125U, with ≥1-grade severity improvement maintained for up to 9 months. Subjects reported natural results and high rates of satisfaction, sustained to Month 9, as well as a wider positive impact on well-being and age assessment. Subject satisfaction is an aspect of clinical importance, which captures treatment effect over time.
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