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.
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
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.
REFERENCES
1. Galderma. Dysport, US Prescribing Information. 2020.
2. Galderma. UK Summary of Product Characteristics for Azzalure, 125 Speywood units, powder for solution for injection. 2021.
3. Punga AR, Alimohammadi M, Fagrell D, et al. A randomized, comparative study to evaluate efficacy and safety of two injection volumes of abobotulinumtoxinA in treatment of glabellar lines. Dermatol Surg. 2016;42(8):967-976.
4. Klassen AF, Cano SJ, Schwitzer JA, et al. Development and psychometric validation of the FACE-Q skin, lips, and facial rhytids appearance scales and adverse effects checklists for cosmetic procedures. JAMA Dermatol. 2016;152(4):443-451.
5. Klassen AF, Cano SJ, Schwitzer JA, et al. FACE-Q scales for health-related quality of life, early life impact, satisfaction with outcomes, and decision to have treatment: Development and validation. Plast Reconstr Surg. 2015;135(2):375-386.
6. Panchapakesan V, Klassen AF, Cano SJ, et al. Development and psychometric evaluation of the FACE-Q aging appraisal scale and patient-perceived age visual analog scale. Aesthet Surg J. 2013;33(8):1099-1109.
7. Monheit GD, Baumann L, Maas C, et al. Efficacy, safety, and subject satisfaction after abobotulinumtoxinA treatment for moderate to severe glabellar lines. Dermatol Surg. 2020;46(1):61-69.
8. Schlessinger J, Cohen JL, Shamban A, et al. A multicenter study to evaluate subject satisfaction with two treatments of AbobotulinumtoxinA a year in the glabellar lines. Dermatol Surg. 2021;47(4):504-509.
9. Cohen JL, Scuderi N. Safety and patient satisfaction of AbobotulinumtoxinA for aesthetic use: a systematic review. Aesthet Surg J. 2017;37(suppl_1):S32-S44.
10. Allergan. Botox Cosmetic, US Prescribing Information. 2020.
11. Evolus. JEUVEAU, US Prescribing Information. 2020.
12. Kaufman J, Cohen JL, Peredo MI, et al. Clinical assessment of 2 licensed abobotulinumtoxinA injection volumes for the treatment of glabellar lines. Dermatol Surg. 2019;45(10):1274-1284.
13. Rzany B, Ascher B, Monheit G. Treatment of glabellar lines with botulinum toxin type A (Speywood Unit): A clinical overview. J Eur Acad Dermatol Venereol. 2010;24 Suppl 1:1-14.
14. Schlessinger J, Monheit G, Kane MA, Mendelsohn N. Time to onset of response of abobotulinumtoxina in the treatment of glabellar lines: a subset analysis of phase 3 clinical trials of a new botulinum toxin type A. Dermatol Surg. 2011;37(10):1434-1442.
15. Cohen JL, Kaufman J, Peredo MI, et al. Assessment of psychological wellbeing after abobotulinumtoxinA treatment: A comparison of 2 reconstitution volumes. Dermatol Surg. 2020;46(2):289-292.
2. Galderma. UK Summary of Product Characteristics for Azzalure, 125 Speywood units, powder for solution for injection. 2021.
3. Punga AR, Alimohammadi M, Fagrell D, et al. A randomized, comparative study to evaluate efficacy and safety of two injection volumes of abobotulinumtoxinA in treatment of glabellar lines. Dermatol Surg. 2016;42(8):967-976.
4. Klassen AF, Cano SJ, Schwitzer JA, et al. Development and psychometric validation of the FACE-Q skin, lips, and facial rhytids appearance scales and adverse effects checklists for cosmetic procedures. JAMA Dermatol. 2016;152(4):443-451.
5. Klassen AF, Cano SJ, Schwitzer JA, et al. FACE-Q scales for health-related quality of life, early life impact, satisfaction with outcomes, and decision to have treatment: Development and validation. Plast Reconstr Surg. 2015;135(2):375-386.
6. Panchapakesan V, Klassen AF, Cano SJ, et al. Development and psychometric evaluation of the FACE-Q aging appraisal scale and patient-perceived age visual analog scale. Aesthet Surg J. 2013;33(8):1099-1109.
7. Monheit GD, Baumann L, Maas C, et al. Efficacy, safety, and subject satisfaction after abobotulinumtoxinA treatment for moderate to severe glabellar lines. Dermatol Surg. 2020;46(1):61-69.
8. Schlessinger J, Cohen JL, Shamban A, et al. A multicenter study to evaluate subject satisfaction with two treatments of AbobotulinumtoxinA a year in the glabellar lines. Dermatol Surg. 2021;47(4):504-509.
9. Cohen JL, Scuderi N. Safety and patient satisfaction of AbobotulinumtoxinA for aesthetic use: a systematic review. Aesthet Surg J. 2017;37(suppl_1):S32-S44.
10. Allergan. Botox Cosmetic, US Prescribing Information. 2020.
11. Evolus. JEUVEAU, US Prescribing Information. 2020.
12. Kaufman J, Cohen JL, Peredo MI, et al. Clinical assessment of 2 licensed abobotulinumtoxinA injection volumes for the treatment of glabellar lines. Dermatol Surg. 2019;45(10):1274-1284.
13. Rzany B, Ascher B, Monheit G. Treatment of glabellar lines with botulinum toxin type A (Speywood Unit): A clinical overview. J Eur Acad Dermatol Venereol. 2010;24 Suppl 1:1-14.
14. Schlessinger J, Monheit G, Kane MA, Mendelsohn N. Time to onset of response of abobotulinumtoxina in the treatment of glabellar lines: a subset analysis of phase 3 clinical trials of a new botulinum toxin type A. Dermatol Surg. 2011;37(10):1434-1442.
15. Cohen JL, Kaufman J, Peredo MI, et al. Assessment of psychological wellbeing after abobotulinumtoxinA treatment: A comparison of 2 reconstitution volumes. Dermatol Surg. 2020;46(2):289-292.
AUTHOR CORRESPONDENCE
Joel Schlessinger MD skindoc@lovelyskin.com
