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



Subjects tended to perceive themselves as younger after treatment with aboBoNT-A. The largest improvement was at month 1, when subjects reported looking 2.1 years younger than before aboBoNT-A treatment (mean value), while the placebo group increased their perceived age by a mean of 0.4 year at month 1 after treatment.

Safety
An overview of TEAEs is presented in Table 2. Serious events occurred in 4 subjects (1.8%) in the aboBoNT-A group and in no subjects in the placebo group. None of these events were related to treatment.

Treatment-related TEAEs occurred in 10.8% of subjects in the aboBoNT-A group and 7.8% in the placebo group, all were of mild or moderate intensity. The most common treatmentrelated TEAEs during the study, occurring in >1 subject in total, were headache, eyelid ptosis and injection-site pain (Table 2). Three subjects (1.3%) developed eyelid ptosis after injection of aboBoNT-A. All ptosis events were mild in intensity and resolved without intervention. No new safety signals were identified.

DISCUSSION

The aim of this study was to evaluate GL treatment using a new higher dilution of the 300-U-vial of aboBoNT-A powder, and a volume of injection of 0.1 mL. The safety results for this injection volume were consistent with the well-known safety profile of aboBoNT-A and in-line with the current prescribing information.1,7-9 No new safety signals were identified. Treatment with aboBoNT-A was well tolerated and there was a low rate of injection site pain (0.4% in the aboBoNT-A group). All treatmentrelated TEAEs were non-serious and mild or moderate in intensity. Eyelid ptosis, all of mild intensity, was reported in 1.3% of subjects, which is lower than in the prescribing information for aboBoNT-A,1 and for other toxin products used in glabellar line treatment including onabotulinumtoxinA10 and prabotulinumtoxinA-xvfs,11 indicating no increase in local spread of toxin with the larger injection volume of aboBoNT-A.

The present study confirmed efficacy also for this dilution and injection volume, including a rapid onset of effect, with a median time to onset of 2 days reported in the subject diary, and a ≥1-grade improvement in GL severity on day 2 reported for 74% and 65% of subjects in the investigator- and subjectassessments, respectively. This is similar to the onset time for aboBoNT-A demonstrated in prior studies.3,8,12-14

In line with previously reported data on aboBoNT-A,7,13 high responder rates were attained on both GL severity scales at 2–4 weeks after treatment with the 0.1-mL-injection volume, including a none-or-mild response in 92% of subjects and a ≥1-grade response in 95%–100% of subjects. The GL severity improvement was sustained up to 6 months after aboBoNT-A treatment, with statistically significant higher responder rates over placebo both in the investigator and subject assessments. Approximately half of the subjects (46% based on ILA; 56%