Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Aug 14;40(9):1000-1008.
doi: 10.1093/asj/sjz248.

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial

Benjamin Ascher  1 , Berthold Rzany  2 , Philippe Kestemont  3 , Said Hilton  4 , Marc Heckmann  5 , Isaac Bodokh  6 , Ernst Magnus Noah  7 , Dominique Boineau  8 , Martina Kerscher  9 , Magali Volteau  10 , Philippe Le Berre  10 , Philippe Picaut  10
Affiliations
Clinical Trial

Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial

Benjamin Ascher et al. Aesthet Surg J. .

Abstract

Background: The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.

Objectives: The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.

Methods: This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up.

Results: Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: "how rested your face looks" (P < 0.0001-0.0415), "I feel okay about myself" (P = 0.0011-0.0399), and "I feel attractive" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively).

Conclusions: Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Least square (LS) mean changes (± standard error [SE]) from baseline to each posttreatment visit in the FACEQ satisfaction with facial appearance overall (Rasch transformed score). Rasch transformed score on a scale from 0 to 100. ASI, abobotulinumtoxinA solution for injection; D, day.
Figure 2.
Figure 2.
Least square (LS) mean changes (± standard error [SE]) from baseline to all posttreatment visits in the FACE-Q psychological well-being (Rasch transformed score). Rasch transformed score on a scale from 0 to 100. ASI, abobotulinumtoxinA solution for injection; D, day.
Figure 3.
Figure 3.
Least square (LS) mean changes (± standard error [SE]) from baseline to all posttreatment visits in the FACE-Q aging appearance appraisal (visual analog scale [VAS]). VAS from −15 (“I look 15 years younger than my actual age”) to +15 (“I look 15 years older than my actual age”). ASI, abobotulinumtoxinA solution for injection; D, day.
See this image and copyright information in PMC

Comment in

References

    1. International Society of Aesthetic Plastic Surgery. ISAPS International Study on Aesthetic/Cosmetic Procedures Performed in 2017 2018. https://www.isaps.org/wp-content/uploads/2019/03/ISAPS_2017_Internationa... Accessed March 27, 2019.
    1. Kosowski TR, McCarthy C, Reavey PL, et al. . A systematic review of patient-reported outcome measures after facial cosmetic surgery and/or nonsurgical facial rejuvenation. Plast Reconstr Surg. 2009;123(6):1819-1827. - PubMed
    1. Cox SE, Finn JC. Social implications of hyperdynamic facial lines and patient satisfaction outcomes. Int Ophthalmol Clin. 2005;45(3):13-24. - PubMed
    1. Cox SE, Finn JC, Stetler L, Mackowiak J, Kowalski JW. Development of the Facial Lines Treatment Satisfaction Questionnaire and initial results for botulinum toxin type A-treated patients. Dermatol Surg. 2003;29(5):444-449; discussion 449. - PubMed
    1. Carruthers J, Carruthers A. Botulinum toxin type A treatment of multiple upper facial sites: patient-reported outcomes. Dermatol Surg. 2007;33(1 Spec No): S10-S17. - PubMed

Publication types

Substances