A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds

Abstract

Background: We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds.

Methods: In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests.

Results: Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane.

Conclusions: In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

Keywords: Hyaluronic acid; Nasolabial fold.

Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1. Schematic diagram of the study design

At two weeks after the treatment, the subjects visited a study center and returned their diary. All the subjects visited a study center at 2, 8, 16, and 24 weeks. At each visit, except for the screening visit, they underwent clinical photography at the sites of the injection of the study material for the assessment of efficacy and safety. WSRS, Wrinkle Severity Rating Scale scores.

Fig. 2. Secondary efficacy outcome of the study

Changes in the Wrinkle Severity Rating Scale from baseline as evaluated by the investigators (Intent-to-Treat set). *P<0.05. These results indicate that there was a significant difference in the rate of improvement between the two groups (P=0.001).

Fig. 3. Preoperative and postoperative photograph of a patient

(A) Preoperative. (B) Postoperative 24 weeks. Left nasolabial fold-Neuramis deep, right nasolabial fold-Restylane.

Fig. 4. Preoperative and postoperative photograph of another patient

(A) Preoperative. (B) Postoperative 24 weeks. Left nasolabial fold-Neuramis deep, right nasolabial fold-Restylane.