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

Author:

Ascher Benjamin1,Rzany Berthold2,Kestemont Philippe3,Hilton Said4,Heckmann Marc5,Bodokh Isaac6,Noah Ernst Magnus7,Boineau Dominique8,Kerscher Martina9,Volteau Magali10,Le Berre Philippe10,Picaut Philippe10

Affiliation:

1. Iena Plastic Surgery Clinic, Paris, France

2. Rzany and Hund, Berlin, Germany

3. Mediti Centre, Antibes-Juan Les Pins, France

4. Dr. Hilton & Partner, Düsseldorf, Germany

5. Starnberg Skin Centre, Starnberg, Germany

6. Dermatology Department, Cannes Hospital, Cannes, France

7. Division of Plastic and Reconstructive Surgery, Red Cross Hospital, Kassel, Germany

8. Clinique Chirurgicale Bel-Air, Bordeaux, France

9. Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany

10. Neurology Development, Ipsen Innovation, Les Ulis, Paris, France

Abstract

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. Level of Evidence: 1

Funder

Ipsen

Publisher

Oxford University Press (OUP)

Subject

General Medicine,Surgery

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