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

74% with a ≥1-grade improvement at maximum frown. Subject assessments (SSA) showed comparable results (Figure 2 and Figure 3).

Glabellar Line Severity Improvement
The composite 2-grade GL responder rate at maximum frown at month 1 (primary endpoint) was significantly higher in the aboBoNT-A group, 65.8% (95% CI: 59.49–72.03), than in the placebo group, 0.0% (95% CI: 0.00–4.68), P<0.001 in the ITT population. Results were similar in the PP population (data not shown).

The highest none-or-mild GL responder rate at maximum frown was 92% of subjects, reached at week 2 in the subject assessments (SSA) and at month 1 in the investigator assessments (ILA). Both scales showed statistically significant, higher none-or-mild severity responder rates for aboBoNT-A compared to placebo from day 2 through month 6 (P<0.001) (Figure 2). In the placebo group, none-or-mild rates were ≤3% on the ILA scale and ≤10% on the SSA scale throughout the 6 month study.

A ≥1-grade improvement from baseline in GL severity at maximum frown was achieved in all subjects treated with aboBoNT-A at month 1 in the investigator assessments (ILA) and in 95% in the subject assessments (SSA). The ≥1-grade responder rates at maximum frown remained significantly higher for the aboBoNT-A group than placebo (P<0.001) throughout 6 months after treatment, both in the ILA and SSA assessments (Figure 3). At month 6, a ≥1-grade improvement in GL severity was reported in 46% of subjects on the ILA scale and 56% of subjects on the SSA scale in the aboBoNT-A group, compared to 15% (ILA) and 25% (SSA) for placebo.

Figure 4 shows treatment results at maximum frown at 1 and 6 months after treatment with aboBoNT-A.

GL severity at rest was improved in 72% of subjects at 1 month after aboBoNT-A treatment versus in 16% for placebo, as assessed by the investigators (ILA). The ≥1-grade improvement responder rates at rest were significantly higher for aboBoNT-A than placebo at all post-treatment visits through month 6 (P<0.001, data not shown). At month 6, 51% (aboBoNT-A) versus 24% (placebo) had a ≥1-grade improvement from baseline at rest.

Duration of Severity Improvement
For subjects who achieved a score of 0 or 1 on both the ILA and the SSA scales concurrently at maximum frown after aboBoNTA- treatment, the median time to loss of this score on both scales was 163 days (5.4 months) after injection, based on the Kaplan- Meier analyses. At 6 months after injection, >50% of the subjects who achieved a score of 0 or 1 had still not returned to baseline scores, ie, retained at least a 1-grade improvement on one or both scales.

Global Aesthetic Improvement
At peak response (month 1), 99% of subjects in the aboBoNT-A group assessed themselves as aesthetically improved in the GL area in the GAIS assessments. Aesthetic improvement was sustained in 94% through month 3, 80% through month 4 and 60% through month 6. In the placebo group, the GAIS responder rate was ≤13% throughout month 6 (Figure 5).

Subject Satisfaction Questionnaire
From month 1 to month 6, ≥91% of subjects in the aboBoNT-A group were satisfied with the aesthetic outcome of their treatment, ≥90% responded that they appeared refreshed, ≥84% were