To compare the safety and efficacy of two different companies’ sodium hyaluronic acid gels for correcting moderate to severe nasolabial folds, and evaluate the non-inferiority of the test device to the control device.

This study included healthy subjects with the desire for nasolabial fold beauty who visited the hospital from March to August 2019, the subjects were randomly assigned to the test group and the control group at a ratio of 1∶1, and followed up to 12 months after a single injection sodium hyaluronic acid gel. The primary efficacy evaluation index was the effective rate of wrinkle improvement in the bilateral nasolabial area before and 6 months injection. The secondary efficacy evaluation indexes were the Wrinkles Severity Rating Scale (WSRS) scores of wrinkle improvement at different time points by the investigator and the subjects, and the Global Aesthetic Improvement Scale (GAIS) scores.

A total of 137 subjects were included per protocol set, with 70 in the test group and 67 in the control group, respectively. Compared with the baseline, the effective rates of improvement of one grade or above in the test group and the control group were 94.29% (66 cases/70 cases) and 94.03% (63 cases/67 cases), respectively, with a difference of 0.26% between the two groups, and the 95% limit of the difference (asymptotic normal) was [-0.08, 0.08], with the lower limit greater the non-inferiority limit of -10%, and the efficacy of the test group was not inferior to that of the control group. At 6 months post-injection, the investigator’s WSRS scores on the left of the test and control groups were (2.13±0.64) and (2.22±0.6) points, respectively, on the right side were (2.23±0.68) and (2.3±0.6) points; the subjects’ WSRS scores on the left were (2.24±0.79) and (2.32±0.84) points, on the right side were (2.18±0.77) and (2.29±0.76) points, respectively. The investigator’s GAIS of the test and control groups that were regarded as improved were 98.57% (69 cases/70 cases) and 97.01% (65 cases/67 cases), respectively; the subjects’ GAIS that were regarded as improved were 88.5% (62 cases/70 cases) and 86.57% (58 cases/67 cases), respectively, and there was no statistically significant difference between the groups all (P>0.05). In addition, there was no significant difference in the incidence of adverse reactions/adverse events between the two groups (P>0.05).

The effectiveness of the test group sodium hyaluronate gel for correcting moderate to severe nasolabial folds was not inferior to that of the control. And it has similar safety.