Safety and efficacy of hyaluronic acid injectable filler in the treatment of nasolabial fold wrinkle: a randomized, double-blind, self-controlled clinical trial

Figures & data

Table 1. The residues of BDDE and protein in MBI-FD.

	Average	Standard deviation
BDDE residues (ppm)	0.11	0.01
Content of protein in sodium hyaluronate gel (µg/g)	7.19	0.34

Figure 1. The injection forces achieved using MBI-FD. (A) MBI-FD exhibits an injection force of 14.30 ± 2.07 N corresponding to the 27-G needle. (B) MBI-FD exhibits an injection force of 36.43 ± 3.11 N corresponding to the 30-G needle.

Figure 2. Cell toxicity of MBI-FD. Morphologic evaluation of L929 cells exposed to different MBI-FD by MTT and observed using a microscope. Magnification 100×.

Table 2. The cytotoxicity of MBI-FD by MTT assay.

Group/Treatments	Viability (%)	Standard deviation
Negative control	100.00	2.94
Positive control	30.67	1.84
1 × MBI-FD (without serum)	83.25	3.58
0.5 × MBI-FD (without serum)	82.23	1.85
1 × MBI-FD (with serum)	100.36	2.71
0.5 × MBI-FD (with serum)	105.74	2.19

Table 3. Improvement rate in the wrinkle severity rating scale.

		Full analysis set (FAS)		Per protocol set (PPS)
Item	Index	MBI-FD group	Control group (Restylane)	MBI-FD group	Control group (Restylane)
Improvement rate (WSRS) at week 24	Valid number (%)	67 (71%)	68 (72%)	54 (69%)	55 (70%)
	Invalid number (%)	28 (29%)	27 (28%)	25 (32%)	24 (31%)
	Total number	95	95	79	79

Table 4. MBI-FD adverse Event evaluation.

Return period (number of individuals)	Week 2 (n = 95)		Week 4 (n = 93)		Week 12 (n = 93)		Week 24 (n = 92)		Week 36 (n = 90)		Week 52 (n = 93)
Group	MBI-FD group	Control group (RESTYLANE)	MBI-FD group	Control group (RESTYLANE)	MBI-FD group	Control group (RESTYLANE)	MBI-FD group	Control group (RESTYLANE)	MBI-FD group	Control group (RESTYLANE)	MBI-FD group	Control group (RESTYLANE)
Erythema	1 (1%)	4 (4%)	1 (1%)	4 (4%)	1 (1%)	2 (2%)	1 (1%)	1 (1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Lumps	1 (1%)	1 (1%)	2 (2%)	1 (1%)	6 (6%)	0 (0%)	3 (3%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Scabs	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	1 (1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Pain	0 (0%)	0 (0%)	1 (1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Pigmentation	1 (1%)	1 (1%)	1 (1%)	1 (1%)	1 (1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Swelling	2 (2%)	6 (6%)	3 (3%)	1 (1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Total number	5	12	8	7	8	2	5	1	0	0	0	0

Data availability statement

Data is available on request from the corresponding author.