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

based on SSA) maintained a ≥1-grade improvement at 6 months after aboBoNT-A treatment, similar to in prior aboBoNT-A studies with the 0.05-mL-volume of injection (Joseph et al, manuscript in preparation).7,8 GAIS results also showed maintained aesthetic improvement in a large proportion of subjects (60%) in the aboBoNT-A group at 6 months, further supporting a long duration of effect also with this dilution.

Importantly, the treatment effects of aboBoNT-A in this study translated into high rates of subject satisfaction, persisting for up to 6 months; ≥91% were satisfied with the aesthetic outcome of their treatment, ≥98% found the results natural-looking, and ≥77% reported broader positive effects of treatment such as feeling more attractive and feeling better about themselves. The FACE-Q scale results confirmed improvement in both satisfaction with GL appearance and psychological well-being, which has also been shown in prior studies with different dilutions of aboBoNT-A.15

Overall, the results from this new dilution study confirmed those obtained in the previously published Phase IV study3 comparing GL treatment with aboBoNT-A using the 0.1 mL versus 0.05 mL injection volume. By this study, we have even more data showing the safety and efficacy of treatment with aboBoNT-A, confirming the rapid onset, long duration, and high subject satisfaction. The safety profile was maintained and there were no signs of increased local spread of toxin with the higher dilution and larger injection volume.

CONCLUSION

In summary, injections with 50 U of aboBoNT-A, using the new dilution resulting in 0.1 mL injection volume per 10 U, was a safe and highly effective treatment of moderate-to-severe GL, with rapid onset and effects persisting for up to 6 months. Aesthetic improvement and subject satisfaction were sustained throughout 6 months.

DISCLOSURES

J. Schlessinger is a clinical trial investigator and paid consultant for Galderma, Merz and Allergan and a shareholder of Allergan and Evolus. D.P. Friedmann is a clinical trial investigator for Galderma. F. Mayoral is a clinical trial investigator for Galderma. D. Mraz Robinson is a clinical trial investigator for Galderma. D.A. Glaser is a clinical trial investigator for Galderma. D. Wu is a clinical trial investigator for Galderma. Dr. Marcus is a clinical trial investigator for Galderma, a speaker for Galderma, Allergan, and Evolus, a trainer for Galderma, and Merz, and an advisory board member for Galderma, Allergan, Merz, and Evolus. Dr. Somenek is a clinical trial investigator for Galderma, a speaker for Galderma, Cutera, Lutronic, and Aesthetics Biomedical, a trainer for Galderma and Allergan, and an advisory board member for Galderma. X. Lin is an employee at Galderma.

Funding: This study was sponsored by Q-Med AB, a part of Galderma.

Presented at Maui Derm 25–29 January 2021

ACKNOWLEDGMENT

Anna-Karin Berg, PhD, provided medical writing assistance on behalf of Galderma.

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AUTHOR CORRESPONDENCE

Joel Schlessinger MD skindoc@lovelyskin.com