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.
10.5999/aps.2015.42.6.721
- Author:
Changsik PAK
1
;
Jihoon PARK
;
Jinmyung HONG
;
Jaehoon JEONG
;
Saik BANG
;
Chan Yeong HEO
Author Information
1. Department of Plastic and Reconstructive Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea. lionheo@snu.ac.kr
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Hyaluronic acid;
Nasolabial fold
- MeSH:
Hyaluronic Acid;
Nasolabial Fold*;
Physical Examination
- From:Archives of Plastic Surgery
2015;42(6):721-728
- CountryRepublic of Korea
- Language:English
-
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.
