Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects

Figures & data

Table 1 Demographic and baseline characteristics

Characteristic	Description
Age, years
Mean (range)	43.07 (29–64)
Female, N (%)	116 (96.67)
Nationality
Han Chinese	N=119
Non-Han Chinese	N=1
Medical history
WSRS severity score (1–5)
3 symmetrical	N=102
4 symmetrical	N=16
4 and 3	N=2

Abbreviation: WSRS, Wrinkle Severity Rating Scale.

Table 2 Treatment characteristics (safety population)

Characteristics	PV	RL
Initial treatment	N=120	N=120
Touch-up treatment	N=1	N=1
Injection volume, median (min, max)
Total, mL	1.00 (0.3, 2.0)	1.00 (0.6, 2.0)

Abbreviations: PV, Princess^® VOLUME; RL, Restylane^®.

Figure 1 WSRS improvement rates assessed by the Independent Review Committee at 24 weeks.

Abbreviations: FAS, full analysis set; PP, per-protocol; PV, Princess^® VOLUME; RL, Restylane^®; WSRS, Wrinkle Severity Rating Scale.

Figure 2 GAIS score assessed by the Independent Review Committee over time for the FAS population.

Abbreviations: FAS, full analysis set; GAIS, Global Aesthetic Improvement Scale; PV, Princess^® VOLUME; RL, Restylane^®.

Figure 3 GAIS score assessed by the subjects over time for the FAS population.

Abbreviations: FAS, full analysis set; GAIS, Global Aesthetic Improvement Scale; PV, Princess^® VOLUME; RL, Restylane^®.

Table 3 Incidence of treatment site AEs

AE	PV	RL
Subjects comprised in the safety assessment population (n=120)
Subjects with any event, N (%)	58 (48.33)	53 (44.17)
Type, N (%)
Swelling	37 (30.83)	35 (29.17)
Pain	26 (21.67)	28 (23.33)
Injection site hemorrhage	14 (11.67)	15 (12.50)
Injection site nodules	20 (16.67)	13 (10.83)
Postoperative wound complications	3 (2.5)	4 (3.33)
Wound complication	1 (0.83)	1 (0.83)
Postprocedural hemorrhage	0 (0.00)	2 (1.67)

Abbreviations: AE, adverse event; PV, Princess^® VOLUME; RL, Restylane^®.