AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data

September 2021 | Volume 20 | Issue 9 | Original Article | 988 | Copyright © September 2021


Published online August 27, 2021

Joel Schlessinger MDa, Daniel P. Friedmann MDb, Flor Mayoral MDc, Deanne Mraz Robinson MDd, DeeAnna Glaser MDe, Douglas Wu MDf, Keith Marcus MDg, Michael Somenek MDh, Xiaoming Lin RN MSi

aSkin Specialists, Omaha, NE
bWestlake Dermatology Clinical Research Center, Austin, TX
cFlor Mayoral, MD, Coral Gables, FL
dModern Dermatology, Westport, CT
eSaint Louis University, St. Louis, MO
fDermatology Cosmetic Laser Medical Associates of La Jolla, San Diego, CA
gMarcus Facial Plastic Surgery, Redondo Beach, CA
hAdvanced Plastic Surgery, Washington, D.C.
iGalderma Laboratories, Fort Worth, TX

Abstract
Background: Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals.
Objective: To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume.
Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA).
Results: Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated.
Conclusion: Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction.

J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130

INTRODUCTION

AbobotulinumtoxinA (aboBoNT-A; Dysport®, Ipsen Ltd, Slough, UK) is approved in the US for treatment of moderate to severe glabellar lines (GL) using a total dose of 50 Speywood units (50 U). According to the current US license,1 a 300-U-vial of this powder formulation is reconstituted with either 1.5 mL or 2.5 mL 0.9% NaCl, and five 10-U-aliquots are then administered to the GL area using corresponding injection volumes of 0.05 mL or 0.08 mL per site.

Increasing the reconstitution volume to obtain a 0.1-mL-volume of injection minimizes the margin of error and is comparable to other botulinum toxin A preparations (onabotulinumtoxinA [Botox®] and incobotulinumtoxinA [Xeomin®]). This volume is also approved for use with aboBoNT-A in some countries, including in the EU.2 In a prior study, similar efficacy was shown when aboBoNT-A was injected using 0.1 mL as for 0.05 mL per injection, with no safety concerns, following reconstitution of a 125-U-vial.3