Global Aesthetic Improvement
The percentage of subjects showing improvement across the study period according to both subject and investigator assessments is shown in Figure 5. All subjects improved at Month 1 according to both investigator and subject assessments.
When asked at baseline, “What effects are you seeking from the treatment,” the most common response was “wanting to improve overall facial appearance” (88%), followed by “preventing signs of ageing” (81%) and “feeling better about myself” (56%). Before treatment, 31% of the subjects reported being “very satisfied” or “somewhat satisfied” with the appearance of their face. After treatment, 87% stated they were “very satisfied” or “somewhat satisfied” at Month 1, 77% at Month 3, and 55% at Month 6. Five subjects (16%) stated they were very dissatisfied with the appearance of the face at baseline; none of the subjects reported “very dissatisfied” at any of the follow-up visits.
At 1, 3, and 6 months after treatment, 61, 55, and 39% of subjects, respectively, reported that they felt “much better” or “very much better” about themselves. In total, 81% of subjects confirmed they were “very satisfied” or “somewhat satisfied” with the treatment after 6 months (Figure 6). Investigators reported that they were “somewhat satisfied” or “very satisfied” with the overall facial aesthetic outcome for 84% of subjects at Month 1.
After ABO treatment of GL, LCL, and FL, more than 70% of subjects felt “very satisfied” or “somewhat satisfied” with their level of skin hydration, elasticity, softness, glow, freshness, structure, and firmness, 6 to 7 months after treatment.
Subjects were asked a series of questions related to how they felt about themselves at baseline and throughout the study. After treatment, the results were generally positive at every timepoint, and even 6 months afterward, around half of the subjects reported that they “agreed” or “strongly agreed” that the treatment improved their attractiveness (52%), facial symmetry/balance (48%), and self-esteem (52%). Subjects also confirmed that the treatment made them feel better about themselves (55%); that they had improved life satisfaction and contentment (48%); that the treatment made them look and feel more successful (32%); that they looked younger than their age (29%); and that they looked the way they felt (52%). One month after the treatment, 100% of subjects said they would recommend the treatment to a friend and would have the treatment again.
There were no serious AEs reported throughout the study. In total, 19 nonserious AEs were reported in 16 subjects; 8 treatment-related (7 subjects) and 11 non–treatment-related (11 subjects). All the treatment-related AEs were mild or moderate (Table 4) and completely resolved in 6 months with the exception of a mild eyelid edema in one subject (3%). Headache was the most common treatment-related AE (3 events in 3 subjects [9%]). Other treatment-related AEs were 1 case of eyelid sensory disorder (3%), 1 case of injection-site bruising (3%), and injection-site edema (2 events in 1 subject [3%]). No cases of brow ptosis were recorded.
The results of this clinical study indicate that ABO alone effectively treated upper facial lines, with a good safety profile and high patient satisfaction. High efficacy was obtained, as 100% of the patients had at least 1-grade improvement in dynamic wrinkles from baseline in GL, and more than 92% for LCL and FL. Effects in dynamic wrinkles lasted for 3 months after treatment in 70% to 84% of the patients, and in 22% to 36% of the patients for 6 months after treatment. There was a marked improvement in wrinkle severity at rest, particularly concerning FL, with 96% of subjects experiencing at least 1-grade improvement 1 month after treatment.
These results showed that the average dose (29 s.U.) used in FL treatment (recommended by the consensus12) was suitable for the treatment of hyperkinetic lines and FL at rest. AbobotulinumtoxinA treatment was generally well-tolerated and associated with high patient satisfaction. The use of botulinum toxins for aesthetic improvement of horizontal FLs requires careful consideration concerning the positioning and shape of the eyebrows and the tension of the frontalis muscle, as treatment may be associated with brow ptosis.13 Of note, mild eyelid edema and eyelid sensory disorder were self-reported but not noticed by the investigator.
By reducing muscle movement, improvement can be seen not only in dynamic wrinkles but also in the static ones. In this study, improvements were observed in some static wrinkles and were more evident in patients presenting with mild static wrinkles. The reduction of static lines with maintenance of some muscle activity, as observed in this study, was a desired and expected result. It avoids a frozen look and improves facial aesthetics, as subjects change the way they use their facial muscles, not only the treated ones.
Concomitant treatment of different ABO indications is commonly used in clinical practice with good results. Some publications have addressed the safety and efficacy of concomitant treatment as well as patient satisfaction and quality of life.4–6,9,10,14 Hexsel and colleagues9 assessed the treatment of the upper, middle, and lower third of the face concomitantly. Significant improvement was observed for GL, LCL, and FL 4 months after treatment and for more than 6 months for GL.
Although methodological differences make it impossible to directly compare our outcomes with those of similar studies examining concomitant administration of other botulinum toxins,3,6 our results provide further evidence concerning the benefits of ABO in achieving at least 1-grade reductions in upper facial line severity and significant improvements in global aesthetic appearance over a 6-month period.
Subject satisfaction is highly important in aesthetic treatment of the upper face, as it impacts a person's perception of their appearance, their quality of life, and self-confidence.15 Satisfaction with a procedure influences a person's decision to continue with a treatment or recommend it to others.11 It has also been suggested that treating multiple upper facial areas, rather than the glabellar area only, leads to greater improvements in self-perception scores and a higher number of subjects perceiving themselves as looking younger than their actual age.15 Treatment of multiple facial areas has been reported to result in improved subject satisfaction and quality of life.14
In this study, we observed an improvement in how the subjects felt about themselves with 87, 77, and 55% of subjects reporting satisfaction with the appearance of their face at 1, 3, and 6 months, respectively. These results are higher than those previously reported by de Boulle and colleagues.16 Furthermore, 81% of subjects confirmed that they were satisfied with the treatment after 6 months. Global aesthetic improvement results were also in line with subject satisfaction. There was a high degree of subject satisfaction with skin quality, reflected in subject satisfaction questionnaires.
AbobotulinumtoxinA is an effective and well-tolerated intervention for the concomitant treatment of the studied upper facial indications. Glabellar lines, lateral canthal lines, and forehead lines improved both at maximum frown and at rest. High global aesthetic improvement and subject satisfaction were maintained over 6 months.
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© 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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