Patient Satisfaction with AbobotulinumtoxinA for Aesthetic Use in the Upper Face: A Systematic Literature Review and Post-hoc Analysis of the APPEAL Study

Riekie Smit; Elena Gubanova; Joely Kaufman; Marina Landau; Beatriz Molina; Bill Andriopoulos; Pascal Maisonobe; Inna Prygova; Alessio Redaelli

. 2021 Feb 1;14(2):E69–E88.

Patient Satisfaction with AbobotulinumtoxinA for Aesthetic Use in the Upper Face: A Systematic Literature Review and Post-hoc Analysis of the APPEAL Study

Riekie Smit ^1,^2,^3,^4,^5,^6,^7,^✉, Elena Gubanova ^1,^2,^3,^4,^5,^6,⁷, Joely Kaufman ^1,^2,^3,^4,^5,^6,⁷, Marina Landau ^1,^2,^3,^4,^5,^6,⁷, Beatriz Molina ^1,^2,^3,^4,^5,^6,⁷, Bill Andriopoulos ^1,^2,^3,^4,^5,^6,⁷, Pascal Maisonobe ^1,^2,^3,^4,^5,^6,⁷, Inna Prygova ^1,^2,^3,^4,^5,^6,⁷, Alessio Redaelli ^1,^2,^3,^4,^5,^6,^7,^✉

PMCID: PMC8211347 PMID: 34221231

Abstract

BACKGROUND: AbobotulinumtoxinA (AboBoNT-A; Dysport^®; Ipsen, Boulogne-Billancourt, France/Azzalure^®; Galderma, Lausanne, Switzerland) is a botulinum neurotoxin type A approved for aesthetic use in the treatment of glabellar lines in adult patients under 65 years in Europe, the United States, and other countries. OBJECTIVE: We sought to analyze current literature on patient satisfaction with aboBoNT-A for upper facial aesthetic indications. METHODS: A systematic review of literature databases (PubMed/MEDLINE, Embase, the Cochrane Library, and Google Scholar) was performed to identify English-language publications reporting on patients with aesthetic indications (including glabellar lines and wrinkles) receiving aboBoNT-A, that assessed patient and/or physician satisfaction with treatment, with no restrictions on comparator studies. Structured data extraction was used to enable inter-study analysis. A post-hoc analysis was also performed to assess patient satisfaction by sex and age, using results from the noninterventional APPEAL study of patients’ satisfaction with aboBoNT-A for treating glabellar lines. RESULTS: Overall, 22 original research papers were identified. Patient satisfaction rates for aboBoNT-A treatment were significantly higher versus placebo from two weeks to between three and five months postinjection. At two to three weeks postinjection, patient satisfaction rates were 52% and 99% across studies. In studies with later time points, patient satisfaction rates were 85 to 87 percent at 5 months and between 25 and 100 percent at 6 months post-injection. Physician satisfaction was also high (97%–100%, across three treatments). No notable differences in patient satisfaction by sex or age were observed in the APPEAL study. CONCLUSION: High rates of patient satisfaction have been achieved with aboBoNT-A treatment for upper facial aesthetic indications. Despite the current recommended interval of ≥12 weeks, satisfaction with the aesthetic results of aboBoNT-A therapy is still evident up to 6 months post-injection in some patients.

Keywords: AbobotulinumtoxinA, botulinum toxin, glabellar lines, lateral canthal lines, crow’s feet, wrinkles, patient satisfaction, Dysport

The short- and long-term efficacy and safety of abobotulinumtoxinA (aboBoNT-A; Dysport^®; Boulogne-Billancourt, France/Azzalure^®; Galderma, Lausanne, Switzerland) for treating glabellar lines have been well established in clinical studies.1–5 AboBoNT-A is a botulinum neurotoxin type A (BoNT-A) approved for aesthetic use in the treatment of glabellar lines in adult patients younger than 65 years in Europe, the United States and other countries.6,7 Approval of aboBoNT-A for facial aesthetic use extends to the treatment of lateral canthal lines (i.e., crow’s feet) in European and Asian countries as well as to hyperfunctional facial lines in Latin America.6,8,9 Current dosing guidelines recommend a minimum treatment interval of at least 12 weeks6,7 and studies have demonstrated that reduced wrinkle severity is commonly seen within 1 to 7 days after injection and persists for 3 to 6 months.1,10

Patients’ satisfaction with their appearance is of the utmost importance in the evaluation of cosmetic treatments and it is increasingly acknowledged that the evaluation of patients’ perspectives is a necessary aspect of providing patient-centered treatment and to inform decision-making.11 Furthermore, real-world data concerning patients’ beliefs and attitudes following long-term aboBoNT-A treatment and whether they vary according to age and sex are limited.

Here, we report results from a systematic review of patient and physician satisfaction with aboBoNT-A for the aesthetic treatment of glabellar lines and other areas of the upper face as reported in the literature up to September 2018. We also report the findings of a post-hoc analysis of results from a real-world observational study (APPEAL)12 of patient satisfaction with glabellar line treatment after three injection cycles of aboBoNT-A, stratifying results by sex and by age group.

METHODS

Systematic literature search and study selection. This systematic literature review was performed in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.13 Searches were conducted in PubMed, EMBASE, the Cochrane Library, and Google Scholar on September 11 and 12, 2018. Search terms were developed by reviewing the background literature for terms related to the research question, in line with the objective outlined above. The full search strategy is presented in Supplementary Table 1. Searches were limited to English-language manuscripts, with no date restrictions. Abstracts from conferences and meetings were excluded. Review articles were also excluded, although their bibliographies were manually searched to identify further articles that met the study inclusion criteria. Citations were downloaded into the reference management software EndNote X7 (Clarivate Analytics, Philadelphia, Pennsylvania) to look for duplicates, which were rechecked manually. Citations and abstracts were screened for inclusion by two reviewers using the eligibility criteria defined using a population, intervention, comparator, outcomes, and setting (PICOS) strategy (Supplementary Table 2).

TABLE 1.

Placebo-controlled Studies Reporting Satisfaction with aboBoNT-A Treatment

STUDY	Ascher 20043	Ascher 200517
INDICATION	Glabellar lines (N=119)	Glabellar lines (N=100)
STUDY DESIGN	Multicenter, randomized, double-blind, placebo-controlled study	Multicenter, randomized, placebo-controlled study followed by an open-label injection
TREATMENT	Total dose administered: AboBoNT-A 25 U (n=34) AboBoNT-A 50 U (n=34) AboBoNT-A 75 U (n=34) Placebo (n=17)	AboBoNT-A 50 U (n=50) Placebo (n=50)
MUSCLE TARGET	Procerus and depressor supercilii and two injection points in the inner first and second thirds of each corrugator	Corrugator supercilii, depressor supercilii, and the procerus
MEASURE OF SATISFACTION	Patient response on a 4-point scale: completely satisfied, satisfied, somewhat satisfied, or not satisfied	Patient response on a 4-point scale: completely satisfied, satisfied, somewhat satisfied, or not satisfied
FIRST/Last SATISFACTION Time Point	Day 14/Month 6 (180 days)	Month 1, after first injection/Month 3, after second injection
RESULTS RELEVANT TO SATISFACTION	Percentages of patients "completely satisfied"/"satisfied"/"somewhat satisfied"/"not satisfied": Day 14: AboBoNT-A 25 U (n=30): 20.0%/50.0%/16.7%/13.3% AboBoNT-A 50 U (n=29): 37.9%/27.6%/24.1%/10.3% AboBoNT-A 75 U (n=30): 36.7%/33.3%/23.3%/6.7% Placebo (n=15): 6.7%/6.7%/13.3%/73.3% Month 1/30 days: AboBoNT-A 25 U (n=29): 34.5%/31.0%/17.2%/17.2% AboBoNT-A 50 U (n=29): 65.5%/20.7%/13.8%/0.0% AboBoNT-A 75 U (n=29): 44.8%/31.0%/20.7%/3.4% Placebo (n=15): 0.0%/6.7%/13.3%/80.0% Month 3/90 days: AboBoNT-A 25 U (n=28): 21.4%/60.7%/3.6%/14.3% AboBoNT-A 50 U (n=29): 37.9%/34.5%/20.7%/6.9% AboBoNT-A 75 U (n=29): 37.9%/34.5%/17.2%/10.3% Placebo (n=15): 13.3%/0.0%/6.7%/80.0% Month 6/180 days: AboBoNT-A 25 U (n=29): 10.3%/58.6%/13.8%/17.2% AboBoNT-A 50 U (n=29): 13.8%/79.3%/3.4%/3.4% AboBoNT-A 75 U (n=29): 3.4%/58.6%/20.7%/17.2% Placebo (n=15): 6.7%/6.7%/0.0%/86.7%	Percentages of patients "completely satisfied"/"satisfied"/"somewhat satisfied"/"not satisfied": Month 1, first injection AboBoNT-A 50 U (n=50): 50.0%/28.0%/8.0%/14.0% Placebo (n=50): 0.0%/10.0%/4.0%/86.0% p<0.001 Month 3, first injection AboBoNT-A 50 U (n=49): 28.6%/44.9%/16.3%/10.2% Placebo (n-49): 2.0%/12.2%/2.0%/83.7% p<0.001 Month 4, first injection AboBoNT-A 50 U (n=16): 25.0%/50.0%/12.5%/12.5% Placebo (n=11): 0.0%/9.1%/18.2%/72.7% p<0.001 Month 5, first injection AboBoNT-A 50 U (n=15): 40.0%/46.7%/6.7%/6.7% Placebo (n=2): 0.0%/0.0%/50.0%/50.0% p=0.048 Month 6, first injection AboBoNT-A 50 U (n=4): 25.0%/0.0%/50.0%/25.0% Placebo (n=1): 0.0%/0.0%/0.0%/100.0% p=0.456 Day of second injection (all patients received aboBoNT as the second injection, including those who had received placebo as their first injection) AboBoNT-A 50 U (n=49): 18.4%/38.8%/26.5%/16.3% Placebo (n=50): 2.0%/10.0%/4.0%/84.0% p<0.001 Month 1, second injection AboBoNT-A 50 U (n=48): 62.5%/22.9%/6.3%/8.3% Placebo (n=43): 60.5%/34.9%/2.3%/2.3% p=0.850 Month 3, second injection AboBoNT-A 50 U (n=47): 57.4%/27.7%/6.4%/8.5% Placebo (n=48): 43.8%/41.7%/8.3%/6.3% p=0.303
SPONSOR	Beaufour Ipsen Pharma SAS	Beaufour Ipsen SAS
STUDY	Ascher 200916	Rzany 20062
INDICATION	Lateral canthal lines (N=220)	Glabellar lines and central forehead wrinkles (N=221)
STUDY DESIGN	Multicenter, randomized, double-blind, parallel-group, placebo-controlled study	Multicenter, double-blind, placebo-controlled, randomized, 16-week trial
TREATMENT	Total dose administered (per side of the face): AboBoNT-A 15 U (n=42) AboBoNT-A 30 U (n=37) AboBoNT-A 45 U (n=40) Placebo (n=43)	AboBoNT-A 30 U, 3 injections (n=73) Placebo, 3 injections (n=37) AboBoNT-A 50 U, 5 injections (n=73) Placebo, 5 injections (n=38)
MUSCLE TARGET	Lateral canthal lines	Medial corrugator muscles and procerus muscle In study arm 2 (aboBoNT-A 50 U), 2 cranial sites covering part of the frontalis muscle
MEASURE OF SATISFACTION	Patient satisfaction with the appearance of their crow’s feet assessed on a 4-point rating scale: 0=very satisfied, 1=satisfied, 2=dissatisfied or 3=very dissatisfied	Patient satisfaction on a 4-point scale: 0=not satisfied, 1=moderately satisfied, 2=satisfied, or 3=very satisfied
FIRST/Last SATISFACTION Time Point	Week 2/Week 24	Week 16/Week 16
RESULTS RELEVANT TO SATISFACTION	Patient satisfaction with treatment at Weeks 2, 4, 8, 12, 16, 20, and 24 postinjection: AboBoNT-A 15 U: 72%, 80%, 72%, 66%, 45%, 35%, and 39% AboBoNT-A 30 U: 71%, 77%, 79%, 74%, 54%, 58%, and 50% AboBoNT-A 45 U: 85%, 89%, 83%, 64%, 48%, 40%, and 30% Placebo: 31%, 33%, 40%, 28%, 23%, 24%, and 30% p≤0.001 vs. placebo for all aboBoNT-A up to and including Week 12 p< 0.05, p<0.01 and p<0.01 vs. placebo for aboBoNT-A 15 U, 30 U, and 45 U, respectively at Week 16 p<0.05 vs. placebo for aboBoNT-A 30 U at Week 20 No significance was reported at Week 24	Percentage of patients who were "very satisfied"/"satisfied"/"moderately satisfied"/"not satisfied" with treatment at Week 16: AboBoNT-A 30 U: 14.7%/17.6%/29.4%/38.2% Placebo, three injections: 0.0%/0.0%/0.0%/100.0% Mean scores were 1.09 and 0.0 for aboBoNT-A and placebo, respectively (p<0.001) AboBoNT-A 50 U: 19.2%/24.7%/23.3%/32.9% Placebo, five injections: 0.0%/5.3%/0.0%/94.7% Mean scores were 1.30 and 0.11 for aboBoNT-A and placebo, respectively (p<0.001)
SPONSOR	Ipsen, Ltd.	Ipsen Pharma

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AboBoNT-A: abobotulinumtoxinA

TABLE 2.

Comparator-controlled Studies Reporting Satisfaction Following Treatment with aboBoNT-A Only

STUDY	Chang 201618	Lowe 200519	Lowe 200620	Lowe 201021	Elridy 201722
INDICATION	Glabellar lines (N=75)	Glabellar lines (N=30)	Glabellar lines (N=62)	Glabellar lines (N=60, Study 1)	Lateral canthal lines (N=40)
STUDY DESIGN	Prospective, randomized, double-blind study	Parallel-group, double-blind, randomized, pilot study vs. onaBoNT-A	Double-blind, randomized, parallel-group study of onaBoNT-A vs. aboBoNT-A	Three-part study: Studies 1 and 2 were double-blind randomized studies; Study 3 was a treatment comparison, non-placebo study. Results from Studies 2 and 3 were not relevant to satisfaction.	Randomized, single-blind, split-face study vs. onaBoNT-A
TREATMENT	AboBoNT-A 60 U in 0.5 mL (n=25) OnaBoNT-A 20 U in 0.5 mL (n=25) IncoBoNT-A 20 U in 0.5 mL (n=25)	AboBoNT-A 50 U OnaBoNT-A 20 U Patient numbers by treatment group were not provided	AboBoNT-A 50 U (n=29) OnaBoNT-A 20 U (n=30)	Study 1: AboBoNT-A 75 U (n=30) OnaBoNT-A 30 U (n=30)	AboBoNT-A 15 U (n=20) OnaBoNT-A 6 U (n=20)
MUSCLE TARGET	Corrugator and procerus muscles	Procerus and corrugator muscles	Procerus muscle and corrugator muscle	Study 1: Glabellar region	Three injection points across the canthal region (orbicularis oculi)
MEASURE OF SATISFACTION	Patients completed the FACE-Q, a 63-question survey that asks patients to evaluate their satisfaction with their overall appearance; age appearance; and the appearance of the cheeks, nasolabial folds, lower face and jawline, chin, and neck. For each FACE-Q section, responses are summed and converted to a Rasch-transformed satisfaction score ( 0=lowest satisfaction, 100=highest satisfaction)	Patient satisfaction with appearance was measured on a scale of 0 (not satisfied) to 6 (extremely satisfied) points	Patients rated their feelings of satisfaction with their appearance, and of attractiveness on a 7-point scale (0=not at all, 7=extremely)	Study 1: patients were asked to assess their own satisfaction with the study treatment on a 5-point scale: (+2=very satisfied, +1=satisfied, 0=impartial, –1=dissatisfied, –2=very dissatisfied)	At the last visit, each patient was asked to complete an evaluation for self-satisfaction and opinion about the improvement in the appearance of wrinkles on both sides of the face, on a scale from 0 to 3, as follows: 0=no improvement, 1=mild improvement, 2=moderate improvement, 3=excellent improvement
FIRST/LAST SATISFACTION TIME POINT	Day 14/Day 14	Week 0/Week 20	Week 8/Week 16	Week 20/Week 20	Day 120/Day 120
RESULTS RELEVANT TO SATISFACTION	Percentage change from baseline in Rasch transformed score for satisfaction with facial appearance overall: AboBoNT-A (n=17): +18.3 Percentage change from baseline in Rasch transformed score for satisfaction with age appearance: AboBoNT-A (n=19): +35.0 Percentage change from baseline in Rasch transformed score for satisfaction with cheeks appearance: AboBoNT-A (n=17): +44.0	Patient satisfaction scores at Weeks 0, 1, 2, 8, 12, 16, and 20, respectively: AboBoNT-A: 2.9, 3.0, 3.2, 3.2, 2.8, 2.8, and 2.9	Mean scores for feelings of satisfaction with appearance at baseline and Weeks 8, 12, and 16 for aboBoNT-A: 2.8±1.08 (baseline), 3.3±1.24, 2.9±1.16, and 2.8±0.94 Mean scores for feelings of attractiveness at baseline and Weeks 8, 12, and 16 for aboBoNT-A: 2.9±0.88 (baseline), 3.1±0.94, 2.7±1.03, and 2.8±0.86	Patient satisfaction with study treatment: AboBoNT-A: 0.96±0.96	Percentage of patients reporting satisfaction ratings on Day 120 of "very good"/"good"/"poor"/"no improvement", respectively: AboBoNT-A (n=20): 40%/60%/0%/0%
SPONSOR	The Center for Human Appearance at the University of Pennsylvania	Allergan, Inc.	Allergan, Inc. (research grant)	Not specified	None
STUDY	De Boulle 200826	Kassir 201323	Lew 200224	Sapra 201725
INDICATION	Glabellar lines and lateral canthal lines (N=40)	Glabellar rhytids and lateral canthal lines (N=93)	Facial wrinkle lines (N=20)	Glabellar, forehead and periorbital wrinkles (N=10)
STUDY DESIGN	Non-randomized, open-label, cross-over study	Prospective, comparative, triple-blinded, single-center, randomized, internally controlled clinical trial	Comparative, randomized study of aboBoNT-A and onaBoNT-A in Korean patients	Single-blind, split-face, randomized study of intradermal and intramuscular injections of aboBoNT-A and onaBoNT-A
TREATMENT	Previous treatment with onaBoNT-A was replicated using aboBoNT-A (1:2.5 dose-conversion ratio); patients were only included if they had been "satisfied" or "extremely satisfied" with the clinical effects of onaBoNT-A, administered within the preceding 6 months, thus 100% satisfaction was a prerequisite of this study	Glabellar (n=59): AboBoNT-A 20 U OnaBoNT-A 8 U Lateral canthal lines (n=61): AboBoNT-A 30 U OnaBoNT-A 10 U	AboBoNT-A 20 U/0.1cm3 (n=6) OnaBoNT-A 5 U/0.1cm3 (n=14)	Average doses administered: OnaBoNT-A: 76.5 U (n=5; intradermally at Week 0: 50 U; intramuscularly at Week 2: 26.5 U) AboBoNT-A: 189.5 U (n=5; intradermally at Week 0: 125 U; intramuscularly at Week 2: 64.5 U)
MUSCLE TARGET	Glabellar area, alone or in conjunction with the lateral canthal lines and/or forehead area	Glabellar: corrugator supercilii muscles Crow’s feet: lateral canthus muscle	Lateral canthal area, glabellar area, forehead, nasal dorsum, and nasolabial fold	Glabellar, forehead, periorbital, perioral, and cheek regions (muscles not specified)
MEASURE OF SATISFACTION	Patient-reported satisfaction based on a 6-point scale (extremely satisfied to extremely dissatisfied) Between-formulation differences in product preferences were evaluated using a sign test (α=0.05).	Patient satisfaction was recorded in a diary card at each follow-up visit, measured based on patients’ own feeling of improvement in appearance of wrinkles (1=minimally satisfied; 5=extremely satisfied); Grades 2 to 4 were not defined in this publication	Not specified	Patient satisfaction measured by questionnaires completed at baseline and post-treatment
FIRST/LAST SATISFACTION TIME POINT	Week 2/Week 16	Week 2/Month 5	Not specified/not specified	Week 2/Week 16
RESULTS RELEVANT TO SATISFACTION	Proportion of patients reporting level of satisfaction ("extremely satisfied" or "satisfied") with their most recent aboBoNT-A treatment at Week 16: 31% Proportion of patients reporting aboBoNT-A was "effective" or "very effective" in making them look younger at Weeks 2, 8, 12, and 16: 73%, 73%, 59%, and 36% Proportion of patients reporting aboBoNT-A was "effective" or "very effective" in making them look rested at Weeks 2, 8, 12, and 16: 80%, 75%, 65%, and 39% Proportion of patients reporting aboBoNT-A was "effective" or "very effective" in making them look less stressed at Weeks 2, 8, 12, and 16: 77%, 74%, 56%, and 33%	Patient satisfaction scores in glabellar lines at 2 weeks and 1, 3, 4, and 5 months postinjection for aboBoNT-A: Grade 5: 52%, 54%, 12%, 0%, and 0% Grade 3: 9%, 1%, 18%, 35%, and 8% Grade 2: 3%, 2%, 5%, 30%, and 13% Patient satisfaction scores in lateral canthal lines at 2 weeks and 1, 3, 4, and 5 months postinjection for aboBoNT-A: Grade 5: 52%, 55%, 25%, 0%, and 0% Grade 3: 7%, 5%, 12%, 50%, and 5% Grade 2: 0%, 0%, 0%, 30%, and 13%	Patient satisfaction following treatment: Satisfied, retained a slight line: n=15 (75%) Slightly improved: n=3 (15%) Unsatisfied: n=2 (10%) Results were not separated by treatment group	Median patient satisfaction scores for aboBoNT-A for wrinkles at Weeks 2, 4, and 16: 1.70, 2.20, and 1.33 Median patient satisfaction scores for aboBoNT-A texture at Weeks 2, 4, and 16, respectively: 1.70, 2.20, and 1.00 Median patient satisfaction scores for aboBoNT-A for tightness at Weeks 2, 4, and 16: 1.60, 1.80, and 1.22 Overall, 75% of patients reported an increase in satisfaction with treatment at Week 2 relative to baseline and 85% of patients reported an increase in satisfaction at Week 4 relative to baseline; overall results were not separated by treatment group
SPONSOR	Allergan, Inc.	Study center	Not specified	None

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AboBoNT-A: abobotulinumtoxinA; incoBoNT-A: incobotulinumtoxinA; onaBoNT-A: onabotulinumtoxinA.

Further details of results for comparator products can be found in Supplementary Table 3.

The patient population was defined as patients with aesthetic indications, such as glabellar lines, while the intervention was aboBoNT-A. No restrictions were placed on comparators. Outcomes were defined as either patient or physician satisfaction with treatment. Study type was any clinical setting, excluding case reports.

Full manuscripts were obtained for abstracts considered eligible from the initial screening. For each manuscript, the relevance was assessed by two reviewers; one reviewer checked all manuscripts for inclusion and consistency of data-extraction forms.

Data extraction and assessment. Study design, population, and outcome data were extracted by each reviewer using a standardized data-extraction form (Supplementary Appendix 1). An assessment of bias was completed using the Cochrane Collaboration's (London, England) tool for assessing the risk of bias in randomized controlled trials.14 A similar approach was used to assess the risk of bias in nonrandomized studies using the Methodological Index for Nonrandomized Studies (MINORS) checklist.15 As a statistical meta-analysis was not conducted, an overall assessment of quality across studies (e.g., heterogeneity and publication bias) was not performed.

The primary objective was to assess patient and physician satisfaction with aboBoNT-A for aesthetic use in the upper face. Results are presented here, in tables and figures and narratively described.

APPEAL study satisfaction by sex and age. The APPEAL study (NCT02353897) was a multicenter, noninterventional, prospective, longitudinal study in patients with moderate-to-severe glabellar lines conducted across six countries between October 2014 and December 2016. Full details of the APPEAL study methodology and results have been previously published.12 In brief, patients received three injection cycles of aboBoNT-A, which were administered in accordance to the investigators’ routine clinical practice. Meanwhile, the minimal interval between injections was in accordance to the local summary of product characteristics, while the maximum recommended treatment interval was less than six months. Patients attended three injection visits and a follow-up visit at three weeks ± seven days postinjection. At each follow-up visit, patients completed a satisfaction questionnaire and, at follow-up visits 1 and 3, investigator satisfaction was recorded. The questions asked at each follow-up visit are available in the supplementary material of the primary publication.12

In this post-hoc analysis of the APPEAL study, we aimed to compare patient satisfaction, stratified by age and sex, after three injection cycles of aboBoNT-A for the treatment of glabellar lines. Patients were adults (aged >18 or >21 years, depending on local legislation) with moderate-to-severe glabellar lines at maximum frown as assessed on the four-point glabellar lines severity scale (0=none, 1=mild, 2=moderate, 3=severe) who were naïve to aesthetic treatments or procedures for glabellar lines. Further exclusion criteria are defined in the primary manuscript.12 All patients provided written informed consent to participate and the decision to receive long-term (≥3 cycles) treatment with aboBoNT-A for glabellar lines was made prior to and independently of the decision to participate in the study.

The primary effectiveness endpoint was patient satisfaction with the treatment of glabellar lines after three injection cycles, assessed on a five-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) and dichotomized variables (satisfied vs. not satisfied [inclusive of neutral]). Secondary endpoints included patient satisfaction after one and two injection cycles and patient satisfaction with individual factors related to satisfaction, including aesthetic outcomes, self-perceived age, natural look, expectations being met, self-feeling improvement, recommendations to family or friends, and the desire to receive another injection.

Statistical analyses. Data are summarized as frequency counts and percentages for all patient satisfaction and questionnaire data, with 95% confidence intervals (CIs) calculated using the Agresti–Coull method for approximate binomial CIs. Analyses were performed on the full study population, including all patients who provided informed consent and who received at least one injection. All statistical analyses were performed using the SAS version 9.4 software program (SAS Institute Inc., Cary, North Carolina).

RESULTS

Literature search and selected studies. In total, 320 studies were identified from the surveyed medical literature databases and the supplementary manual selection of manuscripts from the bibliographies of review articles. Of these, 22 publications met the criteria for primary analysis. Figure 1 shows the PRISMA diagram of all publications evaluated for inclusion and the reasons for exclusion. In Tables 1 to 3, we present the study design, outcome measures, and a summary of satisfaction results from the identified publications.

TABLE 3.

Uncontrolled Studies Reporting Satisfaction with aboBoNT-A Treatment

STUDY	Gubanova 201812	Karbassi 201829	Molina 201527
INDICATION	Glabellar lines (N=150)	Glabellar lines (N=104)	Glabellar lines (N=533)
STUDY DESIGN	International, non-interventional, prospective, longitudinal study	Cross sectional, descriptive study	Large-scale, multicenter, prospective, noninterventional observational study
TREATMENT	AboBoNT-A according to routine clinical practice; maximum recommended treatment interval < 6 months	AboBoNT-A 45 to 60 U (10 to 20 U per injection point)	Dosing was at the discretion of the investigator; mean of aboBoNT-A 10.6 s.U per point, across a mean of 5.3 injection points, but volume not specified
MUSCLE TARGET	Procerus and corrugator (left and right) muscles	Corrugator muscles	Glabellar region (muscles not specified)
MEASURE OF SATISFACTION	Patient-reported questionnaire after each of 3 injection cycles; overall satisfaction, based on a 5-point Likert scale (very satisfied to very dissatisfied) and as a dichotomized variable (satisfied vs. not satisfied); patients' individual satisfaction and factors related to satisfaction were also assessed	Visual analog scale for satisfaction	Patient satisfaction and self-perception after treatment evaluated by questionnaire
FIRST/LAST SATISFACTION TIME POINT	Week 3, first injection/Week 3, third injection	Month 3/Month 3	Week 3/Month 4
RESULTS RELEVANT TO SATISFACTION	Patients reporting overall satisfaction as "very satisfied"/satisfied"/"neutral"/"dissatisfied"/"very dissatisfied": After one injection (n=135): 63.7%/33.3%/2.2%/0.7%/0.0% After two injections (n=112): 65.2%/31.3%/3.6%/0.0%/0.0% After three injections (n=135): 74.1%/25.2%/0.7%/0.0%/0.0% Patients reporting overall satisfaction as "very satisfied" or "satisfied" after first/second/third injection cycle: 97.0%/96.4%/99.3% Patients who would be happy to receive the same treatment again after first/second/third injection cycle: 97.0%/100.0%/98.5% Patients who would recommend this treatment to family or friends after first/second/third injection cycle: 97.8%/100.0%/99.3% Patients who felt "a little", "much" or "a lot" better about themselves after first/second/third injection cycle: 92.6%/96.4%/94.8% Patients reporting the results of the injection meets or exceeds expectations after first/second/third injection cycle: 94.8%/97.3%/97.8% Patients that think the results of treatment look natural after first/second/third injection cycle: 98.5%/99.1%/100.0% Patients reporting they "look much younger than my age" or "a little younger than my age" after first/second/third injection cycle: 82.9%/88.4%/91.9% Percentage of physicians reporting satisfaction (satisfied or very satisfied) after first (n=114)/third (n=101) injection: Glabellar line appearance: 98.3%/100.0% Facial expression: 97.4%/100.0% Overall with treatment: n/a/100.0%	Complete satisfaction after 3 months: 86.5%	Patients who were "very satisfied"/"satisfied"/neutral"/dissatisfied"/"very dissatisfied" with aesthetic outcome: Week 3: 56.7%/38.0%/4.0%/1.1%/0.2% Month 4: 44.9%/44.7%/7.0%/2.3%/1.0% Patients who reported treatment "surpassed"/"met expectations"/"no answer"/"did not have any"/"did not meet" expectations: Week 3: 18.4%/75.0%/0.8%/1.3%/4.5% Month 4: 22.7%/66.0%/0.0%/1.2%/10.1% Patient satisfaction regarding posttreatment appearance at Week 3, yes/no: Results look natural: 97.5%/2.5% Appear rested, as if coming back from vacation: 82.0%/18.0% Patients who reported satisfaction regarding age as "I look younger"/"I look my current age"/"I look older": Baseline: 46.6%/33.5%/20.0% Week 3: 78.9%/20.8%/0.4% Month 4: 74.8%/24.4%/0.8% Patients who felt "much better"/"a lot better"/a little better"/"the same"/"worse" about themselves following treatment: Week 3: 24.2%/38.1%/25.2%/11.9%/0.6% Month 4: 27.6%/36.1%/24.9%/10.7%/0.6% Patients who reported the treatment lead to more (more than one could be selected): Self-esteem/confidence: 44.3% Youth: 38.5% Harmony: 45.4% Beauty: 26.8% None of these: 4.7% No answer: 0.8%
SPONSOR	Ipsen	Not specified	Galderma R&D
STUDY	Punga 201628	Dubina 201331	Farahvash 200734	Kiripolsky 201133
INDICATION	Glabellar lines (N=62)	Glabellar and forehead lines (N=20)	Glabellar lines, frontal lines and lateral canthal lines (N=115)	Facial rhytides (N=185)
STUDY DESIGN	Multicenter, randomized, comparative study of aboBoNT-A at 2 injection volumes	Split-face, randomized controlled trial	Single-arm prospective study	Retrospective, single-site, two-phase study
TREATMENT	AboBoNT-A 50 U: Injection volumes 0.05 mL (n=30) and 0.1 mL (n=32) per injection point	AboBoNT-A, up to 65 U vs. AboBoNT-A up to 65 U + hyaluronic acid filler up to 1 mL	Average units per site per injection: Glabellar: AboBoNT-A 90 U Forehead: AboBoNT-A 150 U Lateral canthus: AboBoNT-A 76 U	Phase 1: AboBoNT-A 10 U/0.1 mL saline, average dose of 93.7 U across injected muscles Phase 2: AboBoNT-A 12 U/0.1 mL saline, average dose of 99.6 U across injected muscles
MUSCLE TARGET	Procerus and corrugator muscles	Bilateral forehead and glabellar	Corrugators, frontalis, lateral orbicularis oculi	According to patient need: lateral canthal lines, depressor anguli oris, frontalis, glabellar, nasalis, mentalis, and platysmal bands
MEASURE OF SATISFACTION	Patient satisfaction with the treatment using a Subject Satisfaction Questionnaire	At the final visit, patients completed a satisfaction survey	Not specified	Not specified
FIRST/LAST SATISFACTION TIME POINT	Month 1/Month 6	Weeks 24–26/ Weeks 24–26	Not specified/not specified	Week 16/Week 16
RESULTS RELEVANT TO SATISFACTION	At Months 1 and 3, ~90% of patients were satisfied with the aesthetic outcome of treatment Patients who found the results natural looking after treatment: 93%–100% between 1 and 6 months Patients who felt more attractive after the treatment: > 50% between 1 and 6 months Patients who looked more rested, as if they had just returned from holiday, at study end (6 months): 63.9% Patients who would have the treatment again: 98.3% Patients who would recommend treatment to someone else: 96.8% Results are for all patients regardless of injection volume	Patient satisfaction after study completion in the aboBoNT-A–only and aboBoNT-A + hyaluronic acid groups: Overall satisfaction (somewhat satisfied/very satisfied): 21%/79% and 26%/74% Would repeat treatment (yes/no): 95%/5% and 89%/11% Would recommend treatment (yes/no): 95%/5% and 95%/5% Feeling about facial wrinkles (better/no change): 79%/21% and 74%/26% Change in happiness regarding facial wrinkles (feel happier/no change): 42%/58% and 37%/63% Change in confidence regarding facial wrinkles (more confident/no change): 42%/58% and 37%/63% Change in anxiety regarding facial wrinkles (more relaxed/no change): 16%/84% and 16%/84% Changes in feelings regarding age and facial wrinkles (feel younger/no change): 53%/47% and 47%/53%	Patients satisfied with treatment (n=108): 91%	Patient satisfaction following treatment: Phase I: 70.9% Phase II: 68.0%
SPONSOR	Galderma (supply of equipment and product)	Medicis Aesthetics Inc. (research grant)	None	None
STUDY	Hexsel 201330	Iozzo 201432
INDICATION	Full face wrinkles (N=90)	Full facial wrinkles (N=223)
STUDY DESIGN	Prospective, single-center, randomized, open-label study of full-face injections of three different doses of aboBoNT-A	Open label, nonrandomized, single group
TREATMENT	Group 1 (n=26): AboBoNT-A 120–165 U Group 2 (n=29): AboBoNT-A 166–205 U Group 3 (n=30): AboBoNT-A 206–250 U	Total dose, aboBoNT-A ~125 U
MUSCLE TARGET	Upper face: Lateral canthal lines (periorbital) wrinkles, glabellar lines, forehead wrinkles; middle face: lower eyelid, nasal wrinkles, malar wrinkles; lower face: perioral wrinkles, asymmetric smile or gummy smile, cellulitic chin, marionette lines	Corrugator, procerus, nasalis, frontalis, orbicularis
MEASURE OF SATISFACTION	Satisfaction and Self-assessment Questionnaire (SSQ); patients completed 9 questions to assess wrinkles, beauty, harmony, and symmetry of their face (each 0–10 points) and the improvement in each of the 4 items (0–100 points)	Facial Line Treatment Satisfaction Questionnaire comprised of 14 statements rated on a 7-point scale (1=very dissatisfied; 7=very satisfied)
FIRST/LAST SATISFACTION TIME POINT	Week 4/Week 24	Week 2/Week 2
RESULTS RELEVANT TO SATISFACTION	Proportion of patients who assessed their level of treatment satisfaction (‘totally satisfied’ or ‘satisfied’) at Weeks 4, 16, 20 and 24: AboBoNT-A 120–165 U: 96.1%, 88.5%, 69.2%, and 88.4% AboBoNT-A 166–205 U: 96.5%, 82.7%, 86.2%, and 96.5% AboBoNT-A 206–250 U: 96.7%, 90.0%, 96.6%, and 100.0% Overall: 96.4%, 87.0%, 84.7%, and 95.3% No significant differences between treatment groups (p=0.728 at Week 16; p=0.055 at Week 20; p=0.306 at Week 24) Mean satisfaction and self-assessment scores for amount of wrinkles at baseline and Weeks 4, 16, 20 and 24: AboBoNT-A 120-165 U: 6.00 (baseline), 5.00, 5.25, 6.00, and 6.00 AboBoNT-A 166-205 U: 7.75 (baseline), 5.50, 5.25, 5.75, and 6.00 AboBoNT-A 211-250 U: 7.00 (baseline), 5.75, 6.00, 6.50, and 6.50 Overall, p<0.001 for aboBoNT-A doses vs. baseline at 16 weeks Mean satisfaction and self-assessment scores for beauty at baseline and Weeks 4, 16, 20 and 24: AboBoNT-A 120-165 U: 5.75 (baseline), 6.75, 6.75, 6.25, and 6.25 AboBoNT-A 166-205 U: 6.25 (baseline), 7.50, 7.25, 6.50, and 6.75 AboBoNT-A 211-250 U: 5.75 (baseline), 7.50, 6.75, 6.50, and 6.25 Overall, p=0.005 for aboBoNT-A doses vs. baseline at 16 weeks Mean satisfaction and self-assessment scores for harmony at baseline and Weeks 4, 16, 20 and 24: AboBoNT-A 120–165 U: 6.25 (baseline), 7.00, 7.00, 6.25, and 6.25 AboBoNT-A 166–205 U: 6.25 (baseline), 7.50, 7.75, 7.25, and 7.25 AboBoNT-A 211–250 U: 6.25 (baseline), 7.50, 7.00, 7.00, and 6.25 Overall, p=0.009 for aboBoNT-A doses vs. baseline at 16 weeks Mean satisfaction and self-assessment scores for symmetry at baseline and Weeks 4, 16, 20 and 24: AboBoNT-A 120–165 U: 6.25 (baseline), 6.75, 6.75, 6.75, and 6.50 AboBoNT-A 166–205 U: 6.50 (baseline), 7.50, 7.50, 7.25, and 7.25 AboBoNT-A 211–250 U: 6.50 (baseline), 7.00, 6.75, 7.00, and 6.50 No significance reported No difference between groups for mean grades concerning the amount of wrinkles, beauty, harmony, and symmetry since baseline	Mean (standard deviation) patient satisfaction scores for each component of the Facial Line Treatment Satisfaction Questionnaire at 2 weeks postinjection: Overall satisfaction: 6.4 (1.1) Improvement in facial lines: 6.1 (1.2) Time to onset: 6.1 (1.1) Improvement in appearance: 6.1 (1.1) Look relaxed: 6.1 (1.1) Appear rested: 6.4 (0.9) Look better: 6.5 (0.8) Look younger: 6.4 (0.9) Look like you feel: 6.1 (1.2) Confidence: 6.0 (1.2) Competitive at work: 6.2 (1.1) Side effects: 6.2 (1.1) No sign of procedure: 6.4 (1.0) No downtime: 6.3 (1.0) Overall, 66% of patients were "very satisfied"
SPONSOR	Galderma (research grant)	Not specified

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Studies of similar design (i.e., placebo-controlled, comparator-controlled, or uncontrolled) are discussed together and by indication within these sections. Furthermore, a summary of patient satisfaction reported as the percentage of patients satisfied with aboBoNT-A treatment at or after 12 weeks (i.e., three months) postinjection is presented in Figure 2.

Placebo-controlled studies. Overall, four double-blind, randomized, placebo-controlled studies were identified that assessed patient satisfaction following treatment with aboBoNT-A (Table 1).2,3,16,17 Three of these studies assessed the statistical significance of aboBoNT-A versus placebo, demonstrating the superiority of aboBoNT-A at various doses for achieving patient satisfaction following treatment of glabellar lines, lateral canthal lines, or multiple sites. The earliest time point at which satisfaction was reported was Week 2, with 66 to 85 percent of patients satisfied with treatment.3,16 At later time points across these studies, satisfaction rates of 45 to 75 percent were reported at four months postinjection,2,16,17 that of 87 percent was reported at five months postinjection,17 and those from 25 to 93 percent were reported at six months following treatment.3,16,17 Results from each of these studies are presented in Figure 2.

In a dose-ranging study by Ascher et al,3 the percentage of patients who were satisfied or completely satisfied by their aboBoNT-A dose (25U, 50U, or 75U) varied across time points, ranging from 66 to 70 percent at two weeks, 66 to 86 percent at one month, 72 to 82 percent at three months, and 62 to 93 percent at six months following treatment, with the highest satisfaction rates recorded in the aboBoNT-A 50 U group. In the placebo group, the percentage of patients satisfied or completely satisfied with treatment ranged from 7 to 13 percent at each time point.

In another study by Ascher et al,17 patients received an injection cycle of aboBoNT-A 50 U or placebo for the treatment of glabellar lines, which was followed by a second injection cycle in which all patients received aboBoNT-A 50 U. The proportion of patients reporting satisfaction with treatment was significantly higher in the aboBoNT-A group than in the placebo group at each time point assessed from 1 month to 5 months after the first injection (p<0.01 to p=0.048), with 75 percent and 87 percent of patients reporting that they were satisfied/completely satisfied with treatment at four and five months postinjection (vs. 9% and 0% in the placebo group), respectively. At six months, the satisfaction rates were higher with aboBoNT-A 50 U but not statistically significant relative to that in the placebo group (25% vs. 0%, respectively). After the second injection cycle, the proportions of patients satisfied/completely satisfied with treatment at one and three months postinjection with aboBoNT-A were 85 percent and 85 percent, respectively, for those who received aboBoNT-A during both injection cycles, and 95 percent and 86 percent, respectively, for those who had received the placebo during the first injection cycle.

In a dose-ranging study by Ascher et al16 of aboBoNT-A versus placebo for the treatment of lateral canthal lines, satisfaction rates were reported from two weeks up to 24 weeks (6 months) postinjection. With all aboBoNT-A doses tested (15 U, 30 U, or 45 U per side), the proportion of patients reporting treatment satisfaction was significantly higher than with the placebo up to 16 weeks (4 months) postinjection (p≤0.001 up to and including Week 12; p<0.05, p<0.01, and p<0.01 for aboBoNT-A 15 U, 30 U, and 45 U, respectively, at Week 16). However, at 20 weeks postinjection, satisfaction rates were significantly higher than with the placebo in the aboBoNT-A 30 U group only.

These high rates of satisfaction (very satisfied or satisfied) across doses were 71 to 85 percent at the first time point recorded (Week 2), peaking at 77 to 89 percent at Week 4, with the highest satisfaction rates associated with the aboBoNT-A dose of 45 U at these time points. At later time points, satisfaction was maintained in 45 to 54 percent of patients at Week 16, 35 to 58 percent at Week 20, and 30 to 50 percent at Week 24, with the highest rates achieved in the aboBoNT-A 30 U group from Week 12 onwards.

Rzany et al2 reported patient satisfaction with treatment at 16 weeks following injection with either aboBoNT-A 30 U or placebo across three injection sites or with aboBoNT-A 50 U or placebo across five injection sites for glabellar lines and central forehead wrinkles. At Week 16 after injections at three sites, 62 percent of patients receiving aboBoNT-A were at least "moderately satisfied" with treatment compared to zero percent in the placebo group (p<0.001). Similarly, after injections were performed at five sites, 67 percent of patients receiving aboBoNT-A were at least "moderately satisfied" with treatment relative to just five percent of patients in the placebo group (p<0.001) at 16 weeks. No statistical comparisons were performed for results according to the number of aboBoNT-A injection sites.

Comparator-controlled studies. Overall, nine comparator-controlled studies were identified that assessed patient satisfaction following treatment with aboBoNT-A (Table 2),18–26 with all except one26 being randomized. Comparator product results for these studies can be found in Supplementary Table 3.

At two weeks postinjection, a change in satisfaction from baseline of +18 percent was reported,18 and between 52 percent and 75 percent of patients reported satisfaction with treatment23,25 after receiving aboBoNT-A injections for glabellar lines or lateral canthal lines or at multiple treatment sites. Additionally, a satisfaction score of 3.2 out of six points was reported at two weeks postinjection (vs. 2.9 points at Week 0).19 At later time points, studies reported between 31-percent and 100-percent rates for patient satisfaction with aboBoNT-A at four months postinjection,22,23,26 as well as satisfaction scores of 2.9 out of six points at five months postinjection (vs. 2.9 at Week 0)19, and 0.96 (on a score range of −2 [dissatisfied] to +2 [very satisfied] points) at five months postinjection.21 In another study, no improvement was observed at four months following aboBoNT-A injection compared to Week 0.20 Three of these comparator-controlled studies had results for the proportion of patients satisfied with treatment after 12 weeks or later and are included in Figure 2.22,23,26

In a study by Chang et al,18 the percentage increase from baseline in satisfaction with overall facial appearance following aboBoNT-A treatment was 18 percent and the percentage increase from baseline in satisfaction with perceived age was 35 percent for aboBoNT-A, both assessed at two weeks postinjection.

Lowe et al19 reported scores of 2.8 to 3.2 points (0=not at all satisfied; 6=extremely satisfied) for aboBoNT-A between Weeks 1 and 20 postinjection (vs. 2.9 points at Week 0), with the highest satisfaction score of 3.2 points first achieved at two weeks postinjection. Similarly, Lowe et al20 evaluated patient satisfaction with appearance, reporting mean scores of between 2.8 and 3.3 points (0=not at all satisfied; 7=extremely satisfied) after eight, 12, and 16 weeks postinjection with aboBoNT-A (2.8 points at Week 0). Mean scores for feelings of attractiveness, assessed on the same scale, ranged between 2.7 and 3.1 points following injection with aboBoNT-A across these time points (vs. 2.9 points at Week 0). For both assessments, the highest scores were achieved at Week 8 postinjection with aboBoNT-A. In another study by Lowe et al,21 a mean value of 0.96 points on a satisfaction scale rangiong from −2 (very dissatisfied) to +2 (very satisfied) points was achieved at 20 weeks postinjection with aboBoNT-A.

At 120 days (approximately 4 months) following treatment with aboBoNT-A in a split-face study by Elridy et al,22 100 percent of patients were satisfied with treatment, with 40 percent reporting their treatment as "very good" and the remaining 60 percent reporting theirs as "good."

In a study by Kassir et al,23 patients reported satisfaction with the improvement in their appearance following treatment for glabellar lines and lateral canthal lines. At two weeks and one month following aboBoNT-A treatment for glabellar lines, 52 percent and 54 percent of patients, respectively, were "extremely satisfied" (Grade 5 on a scale of Grades 1 to 5). At four months following treatment, a moderate level of satisfaction (Grade 3; range of grades not clearly defined) was reported by 35 percent of patients receiving aboBoNT-A. Similar results were observed at these time points following aboBoNT-A treatment for lateral canthal lines, with 52 percent and 55 percent of patients being "extremely satisfied" at two weeks and one month postinjection, respectively, and a moderate level of satisfaction observed in 50 percent of patients at four months following treatment.

In a study by Lew et al,24 patients reported satisfaction following full-face treatment with BoNT-A (either aboBoNT-A or onaBoNT-A [2.5:1 U], results not provided by treatment group). Overall, 15 patients (75%) were satisfied with the results of treatment and retained only a slight line, three patients (15%) felt that the treatment had slightly improved their condition, and two patients (10%) were unsatisfied with their treatment (time point for evaluation was not specified).

Following aboBoNT-A injections in the glabellar, forehead, and periorbital regions, Sapra et al25 reported a high level of patient satisfaction. Patients scored their satisfaction with treatment for several factors (details of the scale used were not specified), including wrinkles (following intramuscular injections), skin texture, and skin tightness, with scores of 1.60 to 1.70 points across factors reported at Week 2, 1.80 to 2.20 points reported at Week 4, and 1.00 to 1.33 points reported at Week 16 postinjection with aboBoNT-A. Overall, regardless of BoNT-A product, 75 percent of patients reported an increase from baseline in satisfaction at Week 2 and 85 percent reported the same at Week 4.

De Boulle26 assessed patients’ satisfaction with aboBoNT-A following treatment of glabellar lines and lateral canthal lines in patients previously treated with another BoNT-A product (dosing was kept consistent with previous treatment at a ratio of 2.5:1 U). Assessments occurred from two weeks until 16 weeks (4 months) postinjection for aboBoNT-A. At 16 weeks postinjection with aboBoNT-A, patients reported a satisfaction rate of 31 percent. The proportions of patients reporting that aboBoNT-A treatment was "effective" or "very effective" in making them look younger, rested, and less stressed were 73 to 80 percent at Week 2 postinjection, 73 to 75 percent at Week 8, 56 to 65 percent at Week 12, and 33 to 39 percent at Week 16 across these parameters.

Uncontrolled studies. Overall, nine uncontrolled studies were identified that assessed patient satisfaction following treatment with aboBoNT-A (Table 3).12,27–34 These uncontrolled studies had varying study designs, including noninterventional, cross-sectional, open-label, single-arm, or retrospective and some compared different treatment regimens of aboBoNT-A. All studies where patients were grouped according to varying aboBoNT-A treatment plans were randomized.28,30,31 Overall, high satisfaction rates were reported across these studies. At the earliest recorded time points, a satisfaction score of 6.4 out of seven points was reported at two weeks postinjection32 and the proportion of patients satisfied or very satisfied with treatment was 95 to 99 percent at Week 3 postinjection.12,27 At later time points, 68 to 90 percent of patients reported satisfaction with treatment at four months postinjection,27,30,33 85 percent reported the same at five months postinjection,30 and 95 to 100 percent reported the same at six months postinjection.30,31 The results from six of these studies are included in Figure 2.27–31,33

In the noninterventional APPEAL study by Gubanova et al,12 patients received three injection cycles of aboBoNT-A for glabellar lines and patients completed a satisfaction questionnaire three weeks after each injection. Regarding overall satisfaction, 97 percent of patients were either "satisfied" or "very satisfied" after one injection cycle, 97 percent were the same after two injection cycles, and 99 percent were the same after three injection cycles. In response to questions regarding factors associated with patient satisfaction (e.g., would receive treatment again or recommend to others, feelings about themselves, expectations being met, natural look, self-perceived age), patient satisfaction rates ranged from 83 to 100 percent, depending on the question after the first and second aboBoNT-A injection cycles and from 92 to 100 percent after the third injection cycle.

Similarly, in a large-scale, single-cycle, noninterventional study of aboBoNT-A in glabellar lines, Molina et al27 reported that 95 and 90 percent of patients reported satisfaction (i.e., either being "satisfied" or "very satisfied") with treatment at three weeks and four months postinjection, respectively. In response to specific factors affecting satisfaction, at three weeks and four months, respectively, 93 percent and 89 percent of patients said treatment met or surpassed their expectations, 79 percent and 75 percent felt they looked younger, and 88 percent and 89 percent felt better (either "much," "a lot," or "a little") about themselves. At Week 3, 98 percent of patients also reported that their posttreatment appearance looked natural; results at four months were not recorded.

In a study by Punga et al,28 patients reported satisfaction after receiving aboBoNT-A 50 U at two injection volumes (0.05 mL and 0.1 mL) in the glabellar lines. Overall, patient satisfaction results were similar between the two injection volumes and, at one and three months postinjection, approximately 90 percent of patients were satisfied with their aesthetic outcomes. Regarding factors affecting satisfaction, 93 to 100 percent of patients across the one-to six-month time period (results not presented by time point) reported that the results were natural looking and at least 50 percent of patients felt more attractive after treatment. At six months following treatment, 64 percent of patients said they looked more rested, 98 percent would receive treatment again, and 97 percent would recommend treatment to someone else. A further study by Karbassi et al29 reported that 87 percent of patients were completely satisfied with treatment at three months after receiving aboBoNT-A 45 to 60 U for glabellar lines.

In a study by Hexsel et al,30 patients received a range of aboBoNT-A doses (120–165 U, 166–205 U, and 206–250 U) injected in wrinkles or other aesthetic indications across the full face. Overall (and across all doses injected), 96 percent (96%–97%) of patients reported they were "satisfied" or "totally satisfied" at four weeks postinjection, 87 percent (83%–90%) of patients reported the same at 16 weeks, 85 percent (69%–97%) of patients reported the same at 20 weeks, and 95 percent (88%–100%) of patients reported the same at 24 weeks. The highest satisfaction rates were consistently reported in the aboBoNT-A 206 to 250 U group, although no statistically significant differences were observed between the dose groups. In response to specific factors associated with patient satisfaction, there were no differences between treatment groups concerning wrinkles, beauty, harmony, or symmetry. Compared with at baseline, there was a significant reduction in wrinkles (p<0.001) and improvements in beauty (p=0.005) and harmony (p=0.009) at 16 weeks postinjection.

In a study by Dubina et al,31 patients received split-face injections of aboBoNT-A and aboBoNT-A with hyaluronic acid filler for the treatment of glabellar lines and forehead lines. Overall, at 24 to 26 weeks following injection with aboBoNT-A and aboBoNT-A with hyaluronic acid filler (respectively) all patients were either somewhat satisfied (21% and 26%) or very satisfied (79% and 74%) and most patients would receive treatment again (95% and 89%) and recommend treatment to others (95% and 95%). In patients who received aboBoNT-A and aboBoNT-A with hyaluronic acid filler, respectively, 79 and 74 percent reported feeling better about their facial wrinkles, 53 and 47 percent felt younger, 42 and 37 percent felt happier about their facial wrinkles, 42 and 37 percent also felt more confidence regarding facial wrinkles, and 16 and 16 percent were more relaxed in terms of their anxiety regarding facial wrinkles.

In a study of aboBoNT-A for full facial wrinkles, Iozzo et al32 reported a mean score of 6.4 points on a seven-point scale (1=very dissatisfied; 7=very satisfied) at two weeks postinjection and 66 percent of patients reported being "very satisfied" with their treatment results. Across specific factors affecting patient satisfaction rated on the same scale, mean scores ranged from six (for "confidence") to 6.5 (for "look better") points. Following injection with aboBoNT-A at two dilutions (10 U/0.1 mL, average dose: 93.7 U; 12 U/0.1 mL, average dose: 99.6 U) for full facial wrinkles, Kiripolsky et al33 reported that 71 and 68 percent of patients were satisfied with aboBoNT-A treatment at Week 16 using the doses of 10 U/0.1 mL and 12 U/0.1 mL, respectively. Furthermore, Farahvash et al34 reported that 91 percent of 108 patients were satisfied with treatment following injection with aboBoNT-A across the glabellar lines, frontal lines, and lateral canthal lines, although the time point for this assessment was not specified.

Physician satisfaction. Only one uncontrolled study of glabellar lines was identified that assessed satisfaction of the treating physician. The APPEAL study, by Gubanova et al,12 reported high rates of physician satisfaction (either "satisfied" or "very satisfied") at three weeks after one injection cycle with aboBoNT-A, whereby 98 and 97 percent of physicians were satisfied with the appearance of patients’ glabellar lines and facial expressions, respectively. Furthermore, after a third injection cycle with aboBoNT-A, all participating physicians (100%) reported satisfaction with the appearance of patients’ glabellar lines, facial expressions, and overall satisfaction with treatment.

APPEAL study satisfaction by sex and age. Of 150 patients enrolled into the APPEAL study,12 137 (91%) were women and 13 (9%) were men. Across age groups, there were 13 patients (9%) aged 18 to 30 years, 32 (21%) aged 31 to 40 years, 58 (39%) aged 41 to 50 years, 34 (23%) aged 51 to 60 years, and 13 (9%) aged older than 60 years. Of the 150 patients enrolled, 137 (91%) completed all three aboBoNT-A treatment cycles. Of the 13 withdrawn patients, 10 were women. By age, seven were aged 31 to 40 years; three were aged 18 to 30 years; and one each was aged 41 to 50, 51 to 60, and older than 60 years.

As shown in Figure 3, all female patients and all except one male patient reported overall satisfaction with treatment, while no patients were "dissatisfied" or "very dissatisfied." Overall, a higher proportion of female patients were "very satisfied" with treatment compared to male patients (75% vs. 67%, respectively), although the number of male patients enrolled in the study was low (Table 4).

TABLE 4.

Outcomes of Patient Satisfaction Evaluation by Sex and Age Group Following Three aboBoNT-A Treatment Cycles in the APPEAL Study

SATISFACTION QUESTIONNAIRE ATTRIBUTES^*	ALL PATIENTS N (%) (N=135/150)	SEX, N (%)		AGE GROUP, N (%)
SATISFACTION QUESTIONNAIRE ATTRIBUTES^*	ALL PATIENTS N (%) (N=135/150)	Men (N=9/13)	Women (N = 126/137)	18–30 years (N = 10/13)	31–40 years (N = 25/32)	41–50 years (N = 57/58)	51–60 years (N = 31/34)	> 60 years (N = 12/13)
"Very satisfied"	100 (74.1)	6 (66.7)	94 (74.6)	8 (80.0)	19 (76.0)	42 (73.7)	23 (74.2)	8 (66.7)
"Satisfied"	34 (25.2)	2 (22.2)	32 (25.4)	2 (20.0)	6 (24.0)	15 (26.3)	7 (22.6)	4 (33.3)
"Neutral"^‡	1 (0.7)	1 (11.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (3.2)	0 (0.0)
"Dissatisfied"	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
"Very dissatisfied"	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
"Happy to receive treatment again"	133 (98.5)	8 (88.9)	125 (99.2)	10 (100.0)	24 (96.0)	57 (100.0)	30 (96.8)	12 (100.0)
"Recommend treatment to family or friends" (yes)	134 (99.3)	8 (88.9)	126 (100.0)	10 (100.0)	25 (100.0)	57 (100.0)	30 (96.8)	12 (100.0)
"Perception of age" (looking younger)§	124 (91.9)	7 (77.8)	117 (92.9)	8 (80.0)	23 (92.0)	56 (98.2)	27 (87.1)	10 (83.3)
"Result of treatment looks natural"	135 (100.0)	9 (100.0)	126 (100.0)	10 (100.0)	25 (100.0)	57 (100.0)	31 (100.0)	12 (100.0)
"Meets or surpasses expectations"	132 (97.8)	8 (88.9)	124 (98.4)	10 (100.0)	23 (92.0)	57 (100.0)	30 (96.8)	12 (100.0)
"Feeling about yourself"II	128 (94.8)	8 (88.9)	120 (95.2)	9 (90.0)	22 (88.0)	56 (98.2)	30 (96.8)	11 (91.7)
"Aesthetic outcome within 3 weeks after injection"^¶	134 (99.3)	8 (88.9)	126 (100.0)	10 (100.0)	25 (100.0)	57 (100.0)	30 (96.8)	12 (100.0)

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^*Percentages are based on the number of patients with evaluable data (N), missing data: 15/150 [men, n=4; women, n=11];

^‡Neither satisfied nor dissatisfied; Satisfaction was indicated by the following responses on the questionnaire: "very satisfied" or "satisfied"; §"much younger" or "a little younger"; II"a lot better", "much better" or "a little better";

^¶"very satisfied" or "satisfied". AboBoNT-A: abobotulinumtoxinA; GL: glabellar lines.

Data for all patients have been previously reported in the primary publication.12

In response to questions regarding factors affecting patients’ satisfaction, the percentage of female patients reporting satisfaction with each factor, as listed in Table 4, was consistently higher, although the small number of male patients enrolled should be taken into account. In particular, a greater proportion of female participants than male participants felt they looked younger (either "a little" or "much") than their actual age (93% vs. 78%, respectively).

As shown in Figure 4, all patients except one in the age group of 51 to 60 years reported overall satisfaction with treatment. The proportion of "very satisfied" patients was similar across age groups from 31 to 60 years (74%–76%), but slightly higher among patients aged 18 to 30 years and slightly lower among those aged older than 60 years (80% and 67%, respectively) (Table 4).

In response to questions regarding factors affecting patients’ satisfaction, the proportion of patients satisfied with each factor, as listed in Table 4, was similar across age groups, with only responses to the "perception of age" and "feelings about yourself" falling below 90 percent in some age groups (Table 4). Patients aged 18 to 30 years and older than 60 years reported the lowest proportion of positive responses for "perceptions of age" (80% and 83%, respectively), while the lowest proportion of positive responses to "feelings about yourself" was in the 31 to 40 years age group. For these two factors, the highest proportion of positive responses were found in the 41 to 50 years age group (98% for both factors). Additionally, across all age groups, 100 percent of patients felt that the "results of treatment look natural."

DISCUSSION

Based on a systematic review of data from studies conducted using various methodologies, most studies report a high rate of patient satisfaction with aboBoNT-A. In three placebo-controlled studies that performed statistical comparisons, patient satisfaction with aboBoNT-A given at varying doses was significant versus with the placebo at time points ranging from two weeks to between three and five months postinjection, depending on the study.2,16,17

In a previous review, Nestor et al35 identified the onset of effect and duration of action as factors of BoNT-A efficacy that are key in determining patient satisfaction. Many of the studies identified in the present review had time points for assessing satisfaction at early and late stages postinjection. Initial satisfaction results were commonly reported at 2 to 3 weeks postinjection, with a patient satisfaction rate of 66 to 85 percent in placebo-controlled studies,3,16 52 to 75 percent in comparator-controlled studies,23,25 and 95 to 99 percent in uncontrolled studies.12,27 However, there were limited results for patient satisfaction in the first two weeks postinjection; thus, the reported studies cannot provide an indication of when patients first start to feel satisfied with the results of treatment. Furthermore, a number of studies demonstrated satisfaction with aboBoNT-A treatment at time points after the recommended retreatment injection of three months (≥12 weeks). At four months postinjection, the proportion of patients satisfied with treatment were 45 to 75 percent in placebo-controlled studies,2,16,17 31 and 100 percent in comparator-controlled studies,22,23,26 and 68 to 90 percent in uncontrolled studies.6,16,23 At five months postinjection, patient satisfaction rates were 87 and 85 percent in placebo-controlled and uncontrolled studies,17,30 respectively, while, at six months postinjection, the reported patient satisfaction rates were 25 to 93 percent in placebo-controlled studies3,16,17 and 95 to 100 percent in uncontrolled studies.30,31

Despite the current recommended interval of at least 12 weeks, this systematic review showed that satisfaction with the aesthetic results of aboBoNT-A therapy were still evident up to six months postinjection in some studies. Similarly, a recent real-word study of satisfaction with twice-yearly aboBoNT-A injections reported that 86 percent of patients were "satisfied" or "very satisfied" with treatment at three months after their first injection and 75 percent of patients remained so at six months after first injection.36 The long-lasting effects of aboBoNT-A were not only reported in terms of patient satisfaction but also have been established in terms of treatment efficacy, as discussed in a recent review by Nestor et al10 This prolonged duration of effect with aboBoNT-A is thought to be due to the higher quantity of active neurotoxins present in doses of aboBoNT-A approved by the United States Food and Drug Administration relative to doses of other approved toxins, as determined in a preclinical study by Field et al.37

It is widely accepted that the assessment of patient satisfaction is the optimal way to determine patients’ opinions about aesthetic procedures and should be considered as the most important factor for defining treatment success.38 In some cases, patients remain satisfied with the treatment effect even after wrinkle severity has returned to baseline condition, as assessed by the investigator.3,36

The post-hoc analyses of data from the APPEAL study showed that, regardless of patient sex and age at baseline, high levels of patient satisfaction could be achieved with aboBoNT-A injections for the treatment of glabellar lines. Interestingly, some small differences were identified in factors affecting satisfaction between women and men, as a higher proportion of women than men reported positive changes after treatment, although the number of male patients included in the APPEAL study was low. Additionally, the lowest proportion of positive responses to "perceptions of age" and "feelings about yourself" were in the younger age group (18–30 and 31–40 years, respectively), yet overall satisfaction in these age groups was high, with 80 and 76 percent of patients, respectively, reporting they were "very satisfied" with treatment. It is possible that, for younger age groups, perception of age is a less important factor in determining their satisfaction with treatment compared to patients who are older. Overall, outcomes of this analysis support an individualized treatment approach that should respect patients’ expectations and preferences.

Limitations. In terms of limitations, it is evident from the results of the systematic review, as summarized in Figure 2, that the proportion of patients satisfied with treatment does vary between studies in all treatment indications, possibly due to differing study designs and patient expectations for treatment. However, in large-scale studies, such as Gubanova et al12 and Molina et al,27 for which the assessment of patient satisfaction with aboBoNT-A was the primary objective, particularly high levels of satisfaction were achieved, with rates of between 95 and 99 percent for satisfaction at Week 3 and 90 percent for satisfaction at four months postinjection reported. Additionally, both the APPEAL study by Gubanova et al12 and the study by Molina et al27 were noninterventional studies performed in a real-life setting, which may explain the high levels of satisfaction, as the physician-patient relationship and overall experience during the consultation can also influence patient satisfaction with treatment.39 In a more formal trial setting, treatment is performed according to a protocol and patients may not feel the consultation is as personalized compared with a real-life setting. Furthermore, the APPEAL post-hoc analysis of satisfaction by sex is limited by the small number of male patients involved and should be interpreted with caution.

CONCLUSION

The results of this systematic literature review demonstrated high rates of patient satisfaction exist following treatment with aboBoNT-A. Satisfaction was observed at the first time points recorded, usually 2 to 3 weeks postinjection, and was maintained in many patients beyond the current recommended retreatment interval (≥12 weeks), with satisfaction evident for up to five or six months in some patients. Furthermore, post-hoc analysis of the APPEAL study data showed that high levels of satisfaction with aboBoNT-A treatment can be achieved regardless of sex or age.

ACKNOWLEDGMENTS

The authors thank all patients involved in the APPEAL study as well as all investigators and research staff at the participating institutions. The authors thank Watermeadow Medical, an Ashfield Company, for their support in developing this systematic literature review.

The authors also thank Jacqueline Harte, BSc (Hons), of Watermeadow Medical, an Ashfield Company, for providing medical writing support, which was sponsored by Ipsen in accordance with Good Publication Practice guidelines.

SUPPLEMENTARY TABLE 1.

Search Terms and Strategy

SEARCH	QUERY
#1	Search (“abobotulinumtoxinA”[Supplementary Concept] OR abobotulinumtoxinA[nm] OR “abobotulinumtoxinA”[All] OR “abobotulinumtoxin A”[All] OR “abobotulinumtoxin-A”[All] OR “Dysport”[All] OR “abobotulinum toxin-A”[All] OR “abobotulinum toxin A”[All] OR “abobotulinum toxinA”[All] OR “abobotulinum toxin A”[All] OR “abobotulinum toxin-A”[All] OR “abobotulinum toxinA”[All] OR “Abobotulinumtoxin Type A”[All] OR “Abobotulinum toxin Type A”[All] OR “aboBoNT-A”[All] OR “aboBoNT A”[All] OR “aboBoNTA”[All] OR “A/Abo”[All] OR “AAbo”[All] OR “A Abo”[All] OR “BoNT-ABO”[All] OR “BoNT ABO”[All] OR “BoNTABO”[All] OR “BoNTA-ABO”[All] OR “BoNTA ABO”[All] OR “BoNTAABO”[All] OR “CNT 52120”[all] OR “CNT52120”[all] OR “CNT-52120”[all] OR “Reloxin”[all] OR “Azzalure”[All] OR “aboA”[all] OR “abo A”[all] OR “AboBTXA”[all]))
#2	Search (("Esthetics"[Mesh] OR "Esthetics"[all] OR "Aesthetics"[all] OR "esthetic"[all] OR "aesthetic"[all]))
#3	Search ("Glabella"[all] OR "Glabellar"[all])
#4	Search ("facial"[all] OR "forehead"[all] OR "frontalis"[all]) AND (line[all] or lines[all])
#5	Search (("Skin Aging"[Mesh] OR wrinkle[all] OR wrinkles[all] OR wrinkling[all] OR rhytides[all] OR rhytide[all] OR rhytid[all] OR rhytids[all]))
#6	Search (#2 OR #3 OR #4 OR #5)
#7	Search (#1 AND #6)
#8	Search Comment[Publication Type] OR Editorial[Publication Type] OR News[Publication Type]
#9	Search #7 NOT #8

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SUPPLEMENTARY TABLE 2.

Patient, Intervention, Comparator, Outcome, Setting (PICOS)

SEARCH	QUERY
P (Patient, Problem or Population)	Patients with aesthetic indications, e.g., glabellar lines, wrinkles
I (Intervention)	AbobotulinumtoxinA (Dysport^® from Ipsen, Paris, France/Azzalure^® from Galderma, Lausanne, Switzerland)
C (Comparison, Control or Comparator)	No restrictions—can be nothing, placebo, other medications, or usual standard of care
O (Outcome)	Satisfaction (patient satisfaction and physician satisfaction)
S (Study type or Setting)	Clinical

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SUPPLEMENTARY TABLE 3.

Comparator-controlled studies reporting satisfaction following treatment with aboBoNT-A and comparator products

STUDY	Chang 20161	Lowe 20052	Lowe 20063
INDICATION	Glabellar lines (N=75)	Glabellar lines (N=30)	Glabellar lines (N=62)
STUDY DESIGN	Prospective, randomized, double-blind study	Parallel-group, double-blind, randomized, pilot study vs. onaBoNT-A	Double-blind, randomized, parallel-group study of onaBoNT-A vs. aboBoNT-A
TREATMENT	AboBoNT-A 60 U in 0.5 mL (n=25) OnaBoNT-A 20 U in 0.5 mL (n=25) IncoBoNT-A 20 U in 0.5 mL (n=25)	AboBoNT-A 50U OnaBoNT-A 20U Patient numbers by treatment group were not provided	AboBoNT-A 50U (n=29) OnaBoNT-A 20U (n=30)
MUSCLE TARGET	Procerus and corrugator (left and right) muscles	Procerus and corrugator muscles	Procerus and corrugator muscles
MEASURE OF SATISFACTION	Patients completed the FACE-Q, a 63-question survey that asks patients to evaluate their satisfaction with their overall appearance; age appearance; and the appearance of cheeks, nasolabial folds, lower face and jawline, chin, and neck where, for each FACE-Q section, responses were summed and converted to a Rasch-transformed score (0=lowest satisfaction; 100=highest satisfaction	Patient satisfaction with appearance was measured on a scale of 0 (not at all satisfied with appearance) to 6 (extremely satisfied with appearance).	Patients rated their feelings of satisfaction with their appearance, and of attractiveness on a 7-point scale (0=not at all; 7=extremely)
FIRST/LAST SATISFACTION TIME POINT	Day 14/Day 14	Week 0/Week 20	Week 8/Week 16
RESULTS RELEVANT TO SATISFACTION	Percentage change from baseline in Rasch-transformed scores for satisfaction with facial appearance overall: AboBoNT-A (n=17): +18.3 OnaBoNT-A (n=18): +28.9 IncoBoNT-A (n-17): +35.7 Overall: p=0.333; onaBoNT-A vs. aboBoNT-A: p=0.365; onaBoNT-A vs. incoBoNT-A: p=0.554; aboBoNT-A vs. incoBoNT-A: p=0.143 Percentage change from baseline in Rasch-transformed scores for satisfaction with age appearance: AboBoNT-A (n=19): +35.0 OnaBoNT-A (n=18): +19.4 IncoBoNT-A (n=19): +33.5 Overall: p=0.788; onaBoNT-A vs. aboBoNT-A: p=0.531; onaBoNT-A vs. incoBoNT-A: p=0.572; aboBoNT-A vs. incoBoNT-A: p=0.950 Percentage change from baseline in Rasch-transformed scores for satisfaction with cheeks appearance: AboBoNT-A (n=17): +44.0 OnaBoNT-A (n=16): +10.8 IncoBoNT-A (n=18): +20.9 Overall: p=0.101; onaBoNT-A vs. aboBoNT-A: p=0.038; onaBoNT-A vs. incoBoNT-A: p=0.512; aboBoNT-A vs. incoBoNT-A: p=0.135	Patient satisfaction scores at Weeks 0, 1, 2, 8, 12, 16, and 20, respectively: AboBoNT-A: 2.9, 3.0, 3.2, 3.2, 2.8, 2.8, and 2.9 OnaBoNT-A: 2.8, 3.2, 4.0, 3.8, 3.9, 3.0, and 3.1 p<0.01 at Week 12 only, in favor of onaBoNT-A	Mean scores for feelings of satisfaction with appearance at baseline and Weeks 8, 12, and 16, respectively: AboBoNT-A: 2.8±1.08 (baseline), 3.3±1.24, 2.9±1.16, and 2.8±0.94 OnaBoNT-A: 2.8±0.99 (baseline), 3.7±1.22, 3.6±1.22, and 2.9±1.26 p=0.02 at Week 12, in favor of onaBoNT-A Mean scores for feelings of attractiveness at baseline and Weeks 8, 12, and 16: AboBoNT-A: 2.9±0.88 (baseline), 3.1±0.94, 2.7±1.03, and 2.8±0.86 OnaBoNT-A: 3.0±0.95 (baseline), 3.6±1.04, 3.4±1.06, and 3.1±1.21 p=0.01 at Week 12, in favor of onaBoNT-A
SPONSOR	The Center for Human Appearance at the University of Pennsylvania	Allergan, Inc.	Allergan, Inc. (research grant)
STUDY	Lowe 20104	Elridy 20175	De Boulle 20086
INDICATION	Glabellar lines (N=60, Study 1)	Lateral canthal lines (N=40)	Glabellar lines and lateral canthal lines (N=40)
STUDY DESIGN	Three-part study: Studies 1 and 2 were double-blind randomized studies; Study 3 was a treatment comparison, nonplacebo study Results from Studies 2 and 3 were not relevant to satisfaction	Randomized, single-blind, split-face study vs. onaBoNT-A	Non-randomized, open-label, cross-over study
TREATMENT	Study 1: AboBoNT-A 75 U (n=30) OnaBoNT-A 30 U (n=30)	AboBoNT-A 15U (n=20) OnaBoNT-A 6U (n=20)	Previous treatment with onaBoNT-A was replicated using aboBoNT-A (1:2.5 dose-conversion ratio); patients were only included if they had been "satisfied" or "extremely satisfied" with the clinical effects of onaBoNT-A, administered within the preceding 6 months, thus 100% satisfaction with onaBoNT-A was a prerequisite of this study
MUSCLE TARGET	Study 1: Glabellar region	Three injection points across the canthal region (orbicularis oculi)	Glabellar area, alone or in conjunction with the lateral canthal lines and/or forehead area
MEASURE OF SATISFACTION	Study 1: patients were asked to assess their own satisfaction with the study treatment on a 5-point scale: 2=very satisfied, 1=satisfied, 0=impartial, –1=dissatisfied, –2=very dissatisfied	At the last visit, each patient was asked to complete an evaluation for self-satisfaction and opinion about the improvement in the appearance of wrinkles, on both sides of the face (0=no improvement, 1=mild improvement, 2=moderate improvement, 3=excellent improvement)	Patient-reported satisfaction based on a 6-point scale (extremely satisfied to extremely dissatisfied) Between-formulation differences in product preferences were evaluated using a sign test (α=0.05).
FIRST/Last SATISFACTION Time Point	Week 20/Week 20	Day 120/Day 120	Week 2/Week 16
RESULTS RELEVANT TO SATISFACTION	Patient satisfaction with study treatment: AboBoNT-A: 0.96 +- 0.96 OnaBoNT-A: 0.96 +- 1.17 No significant difference between treatment groups	Percentage of patients reporting satisfaction ratings on Day 120 of "very good"/"good"/"poor"/"no improvement", respectively: AboBoNT-A (n=20): 40%/60%/0%/0% OnaBoNT-A (n=20): 0%/100%/0%/0% p=0.005 in favor of aboBoNT-A	Proportion of patients reporting level of satisfaction ("extremely satisfied" or "satisfied") with their most recent BoNT-A treatment: OnaBoNT-A Week 20: 100% AboBoNT-A Week 16: 31% Proportion of patients reporting "effective" or "very effective" in making them look younger: AboBoNT-A Week 2, 8, 12 and 16: 73%, 73%, 59% and 36%, respectively OnaBoNT-A Week 20: 83% (p≤0.001 vs. aboBoNT-A Week 16) Proportion of patients reporting "effective" or "very effective" in making them look rested: AboBoNT-A Week 2, 8, 12 and 16: 80%, 75%, 65% and 39%, respectively OnaBoNT-A Week 20: 90% (p≤0.001 vs. aboBoNT-A Week 16) Proportion of patients reporting "effective" or "very effective" in making them look less stressed: AboBoNT-A Week 2, 8, 12 and 16: 77%, 74%, 56%, and 33%, respectively OnaBoNT-A Week 20: 83% (p≤0.001 vs. aboBoNT-A Week 16)
SPONSOR	Not specified	None	Allergan, Inc.
STUDY	Kassir 201323	Lew 200224	Sapra 201725
INDICATION	Glabellar rhytids and lateral canthal lines (N=93)	Facial wrinkle lines (N=20)	Glabellar, forehead and periorbital wrinkles (N=10)
STUDY DESIGN	Prospective, comparative, triple-blinded, single-center, randomized, internally controlled clinical trial	Comparative, randomized study of aboBoNT-A and onaBoNT-A in Korean patients	Single-blind, split-face, randomized study of intradermal and intramuscular injections of aboBoNT-A and onaBoNT-A
TREATMENT	Glabellar (n=59): AboBoNT-A 20 U OnaBoNT-A 8 U Lateral canthal lines (n=61): AboBoNT-A 30 U OnaBoNT-A 10 U	AboBoNT-A 20 U/0.1cm3 (n=6) OnaBoNT-A 5 U/0.1cm3 (n=14)	Average doses administered: OnaBoNT-A: 76.5 U (n=5; intradermally at Week 0: 50 U; intramuscularly at Week 2: 26.5 U) AboBoNT-A: 189.5 U (n=5; intradermally at Week 0: 125 U; intramuscularly at Week 2: 64.5 U)
MUSCLE TARGET	Glabellar: corrugator supercilii muscles Crow’s feet: lateral canthus muscle	Lateral canthal area, glabellar area, forehead, nasal dorsum, and nasolabial fold	Glabellar, forehead, periorbital, perioral, and cheek regions (muscles not specified)
MEASURE OF SATISFACTION	Patient satisfaction was recorded in a diary card at each follow-up visit, measured based on patients’ own feeling of improvement in appearance of wrinkles (1=minimally satisfied; 5=extremely satisfied); Grades 2 to 4 were not defined in this publication	Not specified	Patient satisfaction measured by questionnaires completed at baseline and post-treatment
FIRST/LAST SATISFACTION TIME POINT	Week 2/Month 5	Not specified/not specified	Week 2/Week 16
RESULTS RELEVANT TO SATISFACTION	Patient satisfaction scores in glabellar lines at 2 weeks and 1, 3, 4, and 5 months postinjection: AboBoNT-A: Grade 5: 52%, 54%, 12%, 0%, and 0% Grade 3: 9%, 1%, 18%, 35%, and 8% Grade 2: 3%, 2%, 5%, 30%, and 13% OnaBoNT-A: Grade 5: 31%, 37%, 18%, 0% and 0% Grade 3: 22%, 22%, 23%, 19%, and 0% Grade 2: 3%, 2%, 5%, 45%, and 0% Patient satisfaction scores in lateral canthal lines at 2 weeks and 1, 3, 4, and 5 months postinjection: AboBoNT-A : Grade 5: 52%, 55%, 25%, 0%, and 0% Grade 3: 7%, 5%, 12%, 50%, and 5% Grade 2: 0%, 0%, 0%, 30%, and 13% OnaBoNT-A : Grade 5: 27%, 32%, 19%, 0%, and 0% Grade 3: 19%, 9%, 17%, 20%, and 0% Grade 2: 0%, 0%, 2%, 50%, and 0%	Patient satisfaction following treatment: Satisfied, retained a slight line: n=15 (75%) Slightly improved: n=3 (15%) Unsatisfied: n=2 (10%) Results were not separated by treatment group	Median patient satisfaction scores for wrinkles at Weeks 2, 4, and 16: AboBoNT-A: 1.70, 2.20, and 1.33 OnaBoNT-A: 1.90, 2.00, and 1.44 Median patient satisfaction scores for texture at Weeks 2, 4, and 16: AboBoNT-A: 1.70, 2.20, and 1.00 OnaBoNT-A: 1.40, 2.20, and 0.89 Median patient satisfaction scores for tightness at Weeks 2, 4, and 16: AboBoNT-A: 1.60, 1.80, and 1.22 OnaBoNT-A: 1.30, 2.00, and 0.78 No significant differences between products Overall, 75% of patients reported an increase in satisfaction with treatment at Week 2 relative to baseline and 85% of patients reported an increase in satisfaction at Week 4 relative to baseline; overall results were not separated by treatment group
SPONSOR	Study center	Not specified	None

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Iozzo I, Tengattini V, Antonucci VA. Multipoint and multilevel injection technique of botulinum toxin A in facial aesthetics. J Cosmet Dermatol. 2014;13(2):135–142. doi: 10.1111/jocd.12090. [DOI] [PubMed] [Google Scholar]
Kiripolsky MG, Peterson JD, Guiha I, Goldman MP. A two-phase, retrospective analysis evaluating efficacy of and patient satisfaction with abobotulinumtoxina used to treat dynamic facial rhytides. Dermatol Surg. 2011;37(10):1443–1447. doi: 10.1111/j.1524-4725.2011.02068.x. [DOI] [PubMed] [Google Scholar]
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Field M, Splevins A, Picaut P et al. AbobotulinumtoxinA (Dysport®, onabotulinumtoxinA (Botox®, and incobotulinumtoxinA (Xeomin® Neurotoxin content and potential implications for duration of response in patients. Toxins (Basel). 2018;10(12):535. doi: 10.3390/toxins10120535. [DOI] [PMC free article] [PubMed] [Google Scholar]
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[B17] Ascher B, Zakine B, Kestemont P et al. Botulinum toxin A in the treatment of glabellar lines: scheduling the next injection. Aesthet Surg J. 2005;25(4):365–375. doi: 10.1016/j.asj.2005.05.004. [DOI] [PubMed] [Google Scholar]

[B18] Chang BL, Wilson AJ, Taglienti AJ et al. Patient perceived benefit in facial aesthetic procedures: FACE-Q as a tool to study botulinum toxin injection outcomes. Aesthet Surg J. 2016;36(7):810–820. doi: 10.1093/asj/sjv244. [DOI] [PubMed] [Google Scholar]

[B19] Lowe PL, Patnaik R, Lowe NJ. A comparison of two botulinum type a toxin preparations for the treatment of glabellar lines: double-blind, randomized, pilot study. Dermatol Surg. 2005;31(12):1651–1654. doi: 10.2310/6350.2005.31303. [DOI] [PubMed] [Google Scholar]

[B20] Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar lines: a double-blind, randomized study. J Am Acad Dermatol. 2006;55(6):975–980. doi: 10.1016/j.jaad.2006.07.006. [DOI] [PubMed] [Google Scholar]

[B21] Lowe NJ, Shah A, Lowe PL, Patnaik R. Dosing, efficacy and safety plus the use of computerized photography for botulinum toxins type A for upper facial lines. J Cosmet Laser Ther. 2010;12(2):106–111. doi: 10.3109/14764170903480013. [DOI] [PubMed] [Google Scholar]

[B22] Elridy AS, Zaki RGE, Elshinawy RF. Comparison of the clinical efficacy of abobotulinumtoxin A (ABO) and onabotulinumtoxin A (ONA) in the treatment of crow's feet wrinkles: a split-face study. Semin Ophthalmol. 2017;33(6):739–747. doi: 10.1080/08820538.2017.1418013. [DOI] [PubMed] [Google Scholar]

[B23] Kassir R, Kolluru A, Kassir M. Triple-blind, prospective, internally controlled comparative study between abobotulinumtoxinA and onabotulinumtoxinA for the treatment of facial rhytids. Dermatol Ther (Heidelb). 2013;3(2):179–189. doi: 10.1007/s13555-013-0033-y. [DOI] [PMC free article] [PubMed] [Google Scholar]

[B24] Lew H, Yun YS, Lee SY, Kim SJ. Effect of botulinum toxin A on facial wrinkle lines in Koreans. Ophthalmologica. 2002;216(1):50–54. doi: 10.1159/000048297. [DOI] [PubMed] [Google Scholar]

[B25] Sapra P, Demay S, Sapra S et al. A Single-blind, split-face, randomized, pilot study comparing the effects of intradermal and intramuscular injection of two commercially available botulinum toxin A formulas to reduce signs of facial aging. J Clin Aesthet Dermatol. 2017;10(2):34–44. [PMC free article] [PubMed] [Google Scholar]

[B26] De Boulle K. Patient satisfaction with different botulinum toxin type A formulations in the treatment of moderate to severe upper facial rhytids. J Cosmet Laser Ther. 2008;10(2):87–92. doi: 10.1080/14764170701854679. [DOI] [PubMed] [Google Scholar]

[B27] Molina B, Grangier Y, Mole B et al. Patient satisfaction after the treatment of glabellar lines with Botulinum toxin type A (Speywood Unit): a multi-centre European observational study. J Eur Acad Dermatol Venereol. 2015;29(7):1382–1388. doi: 10.1111/jdv.12881. [DOI] [PubMed] [Google Scholar]

[B28] 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. doi: 10.1097/DSS.0000000000000805. [DOI] [PMC free article] [PubMed] [Google Scholar]

[B29] Karbassi E, Nakhaee N, Zamanian M. The efficacy and complications of a new technique of Abobotulinum-toxin A (Dysport) injection in patients with glabellar lines. J Cosmet Dermatol. 2019;18(1):55–58. doi: 10.1111/jocd.12529. [DOI] [PubMed] [Google Scholar]

[B30] Hexsel D, Brum C, Porto MD et al. Quality of life and satisfaction of patients after full-face injections of abobotulinum toxin type A: a randomized, phase IV clinical trial. J Drugs Dermatol. 2013;12(12):1363–1367. [PubMed] [Google Scholar]

[B31] Dubina M, Tung R, Bolotin D et al. Treatment of forehead/glabellar rhytide complex with combination botulinum toxin a and hyaluronic acid versus botulinum toxin A injection alone: a split-face, rater-blinded, randomized control trial. J Cosmet Dermatol. 2013;12(4):261–266. doi: 10.1111/jocd.12059. [DOI] [PubMed] [Google Scholar]

[B32] Iozzo I, Tengattini V, Antonucci VA. Multipoint and multilevel injection technique of botulinum toxin A in facial aesthetics. J Cosmet Dermatol. 2014;13(2):135–142. doi: 10.1111/jocd.12090. [DOI] [PubMed] [Google Scholar]

[B33] Kiripolsky MG, Peterson JD, Guiha I, Goldman MP. A two-phase, retrospective analysis evaluating efficacy of and patient satisfaction with abobotulinumtoxina used to treat dynamic facial rhytides. Dermatol Surg. 2011;37(10):1443–1447. doi: 10.1111/j.1524-4725.2011.02068.x. [DOI] [PubMed] [Google Scholar]

[B34] Farahvash MR, Arad S. Clostridium botulinum type A toxin for the treatment of upper face animation lines: an Iranian experience. J Cosmet Dermatol. 2007;6(3):152–158. doi: 10.1111/j.1473-2165.2007.00325.x. [DOI] [PubMed] [Google Scholar]

[B35] Nestor M, Ablon G, Pickett A. Key parameters for the use of abobotulinumtoxinA in aesthetics: Onset and duration. Aesthet Surg J. 2017;37(Suppl_1):S20–S31. doi: 10.1093/asj/sjw282. [DOI] [PMC free article] [PubMed] [Google Scholar]

[B36] Shamban A, Cohen J, Schlessinger J, Jacob C, Karimi K, Maas C. Subject satisfaction with a twice-yearly retreatment schedule for abobotulinumtoxinA—interim results from a multi-center study. Abstract 99884. Presented at the 22nd International Master Course on Aging Science World Congress; January 30–February 1, 2020. Paris, France.

[B37] Field M, Splevins A, Picaut P et al. AbobotulinumtoxinA (Dysport®, onabotulinumtoxinA (Botox®, and incobotulinumtoxinA (Xeomin® Neurotoxin content and potential implications for duration of response in patients. Toxins (Basel). 2018;10(12):535. doi: 10.3390/toxins10120535. [DOI] [PMC free article] [PubMed] [Google Scholar]

[B38] Ching S, Thoma A, McCabe RE, Antony MM. Measuring outcomes in aesthetic surgery: a comprehensive review of the literature. Plast Reconstr Surg. 2003;111(1):469–480. doi: 10.1097/01.PRS.0000036041.67101.48. discussion 481–462. [DOI] [PubMed] [Google Scholar]

[B39] Redaelli A, Siddiqui Syed S, Liu X et al. Two multinational, observational surveys investigating perceptions of beauty and attitudes and experiences relating to aesthetic medical procedures. J Cosmet Dermatol. 2020;19(11):3020–3031. doi: 10.1111/jocd.13349. [DOI] [PMC free article] [PubMed] [Google Scholar]

PERMALINK

Patient Satisfaction with AbobotulinumtoxinA for Aesthetic Use in the Upper Face: A Systematic Literature Review and Post-hoc Analysis of the APPEAL Study

Riekie Smit, MD

Elena Gubanova, MD

Joely Kaufman, MD

Marina Landau, MD

Beatriz Molina, MD

Bill Andriopoulos, PhD

Pascal Maisonobe, MSc

Inna Prygova, MD

Alessio Redaelli, MD

Abstract