Nasolabial Fold Wrinkle Severity
Considering both right and left nasolabial folds, the investigators rated ≥54% as improved (≥1-step improvement from baseline) at 6 months after first and second treatment. At least 46% and 54% were improved 12 months after the first and second treatment, respectively.
Blinded evaluators’ retrospective evaluation using photographs, resulted in 28%–33% of right nasolabial folds, and 24%-38% of left nasolabial folds being assessed as improved during the study.
Sub-study on Chin Evaluation
Seventy-nine (79) female subjects with mean age 39.5 years (range, 28–49) were included in the sub-study. For these subjects, total mean volume injected in the chin, including both treatments with touch-up was 1.6 mL. Six months after first treatment, most chins (94%) were assessed as improved from 2D photographs (Figure 5). For subjects with chin retrusion at baseline (n=64), GCRS improvement rate was highest (63%) 12 months after second treatment (Figure 6). For JSS, improvement was also highest after the second treatment (57% at 6 months after treatment and 52% at 12 months after treatment; Figure 6).
Safety
The most common symptom reported through the subject diaries was tenderness in all treatment areas. Reporting of symptoms was generally declining 3 days after treatment, and with the exception of a few cases, symptoms were resolved after 14 days.
In total, 260 adverse events were reported by 64 subjects (64%), of which 5 events were serious. Twenty-nine (29) adverse events in 16 subjects (16%) were considered related to study product or treatment procedure, none of these were serious. Most commonly reported related adverse events were implant site pain with 13 events in 5 subjects (5%), and implant site bruising with 7 events in 6 subjects (6%). All related events were mild (79%) or moderate (21%). The frequency of reported adverse events decreased with the second treatment (9 events compared to 20 events after first treatment). Median duration of related events was 16 days; all events resolved with follow-up.
DISCUSSION
Modern treatment plans in clinical aesthetics require a full-facial
assessment with attention to surface, volume and movement
of all facial areas. The focus of treatment should preferably
involve the whole face rather than certain areas, as treatment
of one area will affect the overall balance and proportions of
the face.11 Treatment plans should also be based on patients’
individual treatment goals within their own ethnic aesthetic
boundaries. Due to an increasing number of treatments and
partly different treatment needs in Asia compared to western
