A 52-week follow-up, multi-center, randomized, double-blinded comparison of efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in Chinese population

Figures & data

Figure 1. Subject disposition. Three analysis populations were defined for the study: full-analysis-set (FAS, including all subjects injected at least once), per protocol set (PPS, including all subjects who completed all planned treatments without major protocol deviations), and safety set (SS, including all subjects who received injections and underwent at least one post-treatment safety assessment).

Table 1. Baseline demographics and characteristics (FAS).

	Test control
	n = 170	n = 169	Total (n = 339)
Sex [n (%)]
Male	12(7.06)	4(2.37)	16(4.72)
Female	158(92.94)	165(97.63)	323(95.28)
Age (year)
n	179	169	339
Mean ± SD	43.79 ± 8.89	42.53 ± 9.41	43.16 ± 9.16
Median	43.00	42.00	43.00
Min, max	20.00, 64.00	21.00, 64.00	20.00, 64.00
Weight (kg)
n	170	169	339
Mean ± SD	58.86(9.50)	57.02(7.58)	57.94(8.63)
Median	58.00	56.00	57.00
Min, max	40.00, 92.00	38.00, 80.00	38.00, 92.00
Height (cm)
n	170	169	339
Mean ± SD	162.31 ± 6.14	161.65 ± 5.34	161.98 ± 5.76
Median	161.00	162.00	161.00
Min, max	148.00, 184.00	150.00, 177.00	148.00, 184.00

Table 2. Response rates and differences in response rates based on the WSRS (at least one-point improvement) at week 24 by a blinded evaluator.

Population	Project	Cutegel n (%)	Restylane n (%)	Differences	95% CI	CMH	p Value
FAS	Cutegel-Restylane	131(77.06%)	125(73.96%)	3.09%	(−6.06%, 12.24)	2.805	.003
PPS	Cutegel-Restylane	125(81.17%)	121(77.56%)	3.60%	(−5.39%, 12.60)	2.963	.002

Figure 2. Comparison of response rates based on the WSRS, as assessed by a blinded evaluator during follow-up.

Figure 3. Comparison of response rates based on the GAIS as assessed by a blinded evaluator during follow-up.

Figure 4. Comparison of response rates based on the GAIS as assessed by subjects during follow-up.

Table 3. Incidence of treatment site responses.

Treatment site responses	Cutegel	Restylane	Total	p
Subjects with any treatment site response, n (%)	148(87.06)	148(87.57)	296(87.32)	1.000
Type, no. of subjects, n (%)
Swelling	139(81.76)	136(80.47)	275(81.12)	.783
Pain	133(78.24)	126(74.56)	259(76.40)	.445
Bruising	83(48.82)	80(47.34)	163(48.08)	.828
Erythema	83(48.82)	80(47.34)	163(48.08)	.828
Pruritus	63(37.06)	65(38.46)	128(37.76)	.823
Induration	2(1.18)	0(0.00)	2(0.59)	.499
Nodule	1(0.59)	0(0.00)	1(0.29)	1.000

Data availability statement

Data are available on reasonable requests from the corresponding author.