IncobotulinumtoxinA for Glabellar Frown Lines in Chinese Subjects: A Randomized, Double-blind, Active-Controlled Phase-3 Study

Yan Wu; Susanna Roll; Gudrun Klein; Thorin L Geister; Michael A Makara; Bi Li

doi:10.1097/GOX.0000000000004956

IncobotulinumtoxinA for Glabellar Frown Lines in Chinese Subjects: A Randomized, Double-blind, Active-Controlled Phase-3 Study

Plast Reconstr Surg Glob Open. 2023 May 26;11(5):e4956. doi: 10.1097/GOX.0000000000004956. eCollection 2023 May.

Authors

Yan Wu¹, Susanna Roll², Gudrun Klein², Thorin L Geister², Michael A Makara³, Bi Li⁴

Affiliations

¹ From the Peking University First Hospital, Beijing, China.
² Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.
³ Formerly Merz North America, Inc., Raleigh, N.C.
⁴ Peking University Third Hospital, Beijing, China.

Abstract

This study evaluated the efficacy and safety of IncobotulinumtoxinA 20 U for treatment of glabellar frown lines in Chinese subjects.

Methods: This was a prospective, randomized, double-blind, active-controlled, phase-3 study conducted in China. Subjects with moderate to severe glabellar frown lines at maximum frown were randomized to receive IncobotulinumtoxinA (N = 336) or OnabotulinumtoxinA (N = 167).

Results: For the primary efficacy endpoint at day 30, response rates at maximum frown (score "none" or "mild") on the Merz Aesthetic Scales Glabella Lines - Dynamic were comparable between IncobotulinumtoxinA (92.5%) and OnabotulinumtoxinA (95.1%) per investigator's live rating. Noninferiority of IncobotulinumtoxinA versus OnabotulinumtoxinA was successfully demonstrated, as the two-sided 95% confidence interval of -0.97% to 0.43% for the difference in Merz Aesthetic Scales-based response rates (-0.27%) lay completely above the predefined noninferiority margin of -15%. For the secondary efficacy endpoints assessed at day 30, Merz Aesthetic Scales-based response rates (score "none" or "mild") at maximum frown were similarly comparable between both groups per subject (>85%) and independent review panel (>96%) rating. Per Global Impression of Change Scales, greater than 80% of subjects and greater than 90% of investigators in both groups rated treatment results as at least "much improved" at day 30 compared with baseline. Safety profiles were consistent between groups; IncobotulinumtoxinA was well tolerated, and no new safety concerns were identified in Chinese subjects.

Conclusion: IncobotulinumtoxinA 20 U is safe and effective for treatment of moderate to severe glabellar frown lines at maximum frown in Chinese subjects and is noninferior to OnabotulinumtoxinA 20 U.