Global Aesthetic Improvement Scale
Aesthetic improvement was high for both groups as assessed both by investigators and subjects. All subjects (100%) were improved at all visits for both sides of the face according to investigators, with ≥61% being very much improved. Also, the majority (≥86.4%) were improved during the study based on subjects’ own evaluation (Figure 4).
FACE-Q Appraisal of Nasolabial Folds
Subjects from both groups were satisfied with how their nasolabial folds looked following treatment through week 48; mean total scores at baseline was 39.4 and 37.8 in the reference group and treatment group, respectively, increasing to 79.9 for the reference group and 74.3 for the treatment group at week 48, representing a change from baseline of 40.5 and 36.4, respectively.
Subject Satisfaction
Subject satisfaction was high and lasted across week 48 for both groups (Figure 5). A majority of subjects would recommend both the 5 mL (90.5%) and 8 mL (86.2%) treatment to a friend at week 48. Also, most subjects would choose to receive the treatment again (treatment group: 89.7%; reference group: 81.0%).
Safety
Sculptra Aesthetic, reconstituted with 8 mL SWFI + 1 mL of 2% lidocaine, was generally safe and well tolerated. Adverse events considered related to the study product or injection procedure were reported by 7 subjects (11.9%) in the treatment group and by 7 subjects (33.3%) in the reference group.
The most common related adverse events overall were headache (2 subjects in the reference group and 1 subject in the treatment group), rhinorrhea (2 subjects in the reference group), and perioral hypoaesthesia (1 subject each in the reference and treatment group). All related adverse events reported in the treatment group were mild in intensity. In the reference group, 2 subjects experienced related adverse events of moderate intensity (one event of rhinorrhea and 2 events of headache). No serious related adverse event was reported. The maximum duration for any resolved related adverse event was 166 days (papule) in the reference group and 11 days (herpes simplex) in the treatment group. In the reference group, 1 subject experienced a papule and 1 subject had a nodule. In the treatment group, a nodule (bump) was reported for 1 subject (ongoing at study end) and there was one event of short-lasting induration (hardening) for 1 subject. All these 4 events were palpable but not visible or inflammatory. They were considered mild in severity and no action was required.
As expected, almost all subjects reported symptoms through the subject diaries for either side of the face. The addition of 1 mL of 2% lidocaine in the treatment group was effective for reducing pain at injection; mean pain score difference (after treatment score minus before treatment score) was lower after all injections in the treatment group (range, 0.4 to 1.3) compared with the reference group (range, 2.1 to 3.0) based on the 11-point numeric pain scale.
DISCUSSION
This study evaluated alternative reconstitution and injection
procedures for Sculptra Aesthetic, ie, 8 mL SWFI + 1 mL
2%-lidocaine injected subdermally immediately after
reconstitution. The primary objective for effectiveness was
to confirm comparable treatment results in reducing wrinkle
severity of nasolabial folds in both study groups at week 48. The
