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

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 assess satisfaction with FACE-Q after glabellar-line (GL) injection. Objectives To evaluate patient-satisfaction with ASI for GL treatment using three FACE-Q scales: facial appearance, psychological well-being, and aging appearance. Methods 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 (LS) mean changes from baseline were associated with ASI treatment (N=125) versus 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). At all visits there were significant differences (ASI vs placebo) 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 LS mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigator’s 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 and facial appearance, and importantly psychological well-being, were demonstrated with ASI using FACE-Q scales up to 5–6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.

Long-term Efficacy and Safety of Liquid AbobotulinumtoxinA Formulation for Moderate-to-Severe Glabellar Lines: A Phase III, Double-Blind, Randomized, Placebo-Controlled and Open-Label Study

“…The results from the DBPC period were similar to those observed with the same 3 FACE-Q outcome measures during the previously mentioned single-cycle Phase III aboBoNT-A solution study. 11 Furthermore, in the present study, the magnitude of change observed compared with cycle baseline was consistent across repeated treatment cycles for each of the 3 FACE-Q scales. To the authors’ knowledge, this is the first study to report the impact of aboBoNT-A treatment on satisfaction as assessed by FACE-Q over repeat cycles in a prospective clinical study.…”

“…Full details of the FACE-Q scales and associated questions have been published previously. 11 , 13-15 …”

“… 9 , 10 The Phase III study of aboBoNT-A solution also demonstrated high levels of patient satisfaction with the appearance of glabellar lines following treatment (80.9% at Day 29), as well as significant improvements compared with placebo on the FACE-Q patient-reported outcome measure scales for satisfaction with facial appearance overall, psychological well-being, and aging appearance. 10 , 11 Furthermore, a long duration of action was demonstrated during the Phase III study of up to 6 months postinjection. 10 AboBoNT-A solution was well-tolerated in both the Phase II and Phase III studies, with no new or unexpected adverse events (AEs) compared with the known profile of BoNT-A products.…”

Facial Line Outcomes (FLO-11) and Facial Line Satisfaction Questionnaire (FLSQ) Meet FDA Patient-Reported Outcome Guidance

“…The recent article by Dr Ascher and colleagues titled “Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial” highlights the importance of patient-reported outcome (PRO) measures in facial aesthetic clinical trials. 1 Although we completely agree with the importance of PROs in assessing aesthetic conditions and treatments, we noted inaccurate claims that 2 PRO measures used for assessing outcomes with botulinum toxin type A (BoNTA), the Facial Line Outcomes (FLO) Questionnaire and the Facial Line Satisfaction Questionnaire (FLSQ), are not in alignment with FDA PRO guidance. Specifically, the authors stated:…”

Response to “Facial Line Outcomes (FLO-11) and Facial Line Satisfaction Questionnaire (FLSQ) Meet FDA PRO Guidance”

“…A recent Letter to the Editor by Dr Patel and colleagues, entitled “Facial Lines Outcomes (FLO-11) and Facial Line Satisfaction Questionnaire (FLSQ) Meet FDA PRO Guidance” 1 noted an inaccuracy in a statement in the introduction of our paper entitled, “Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.” 2 In our introduction, we reference 2 review articles by Morley et al 3 and Kosowski et al, 4 both of which note that very few patient-reported outcome (PRO) measures for aesthetic procedures are aligned with the recommendations for the development and validation of PRO measures defined in each review. As an example, we had referred to the US Food and Drug Administration (FDA) criteria for PRO measures, as discussed by Morley et al 3 Dr Patel and colleagues have highlighted that both of these reviews 3 , 4 in fact refer to the previous versions of these 2 measures, which have since been updated and developed in accordance with FDA PRO guidance.…”