S afetya nd Efficacy of Cros s-lni ke d Hy aluronic Acid Revanesse Ultra for Treatment of Nasolabial Folds
10.3969/j.issn.1674-9081.2016.02.002
- VernacularTitle:水晶纳交联透明质酸用于鼻唇沟皱纹治疗的安全性和有效性
- Author:
Hai-Ru CAO
1
;
Xiao LONG
;
Zhi-Fei LIU
;
Ang ZENG
;
Ming BAI
;
Xiao-Jun WANG
Author Information
1. 中国医学科学院 北京协和医学院 北京协和医院整形外科
- Keywords:
hyaluronic acid;
nasolabial folds;
dermal filler;
efficacy;
safety
- From:
Medical Journal of Peking Union Medical College Hospital
2016;7(2):88-92
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety and efficacy of cross-linked hyaluronic acid Revanesse Ultra for treatment of nasolabial folds in Chinese population .Methods A total of 120 participants were enrolled in this prospective , randomized , positive controlled , non-inferiority clinical trial in accordance to inclusion and ex-clusion criteria , and signed informed consents were obtained .The participants were numbered in the order of en-rollment and randomized into Restylane group and Revanesse group , receiving hyaluronic acid injection to correct bilateral nasolabial folds .Each person received 1 or 2 times of injection ( a touch-up injection could be adminis-tered 4 weeks post the first injection ) .According to the original depth of the wrinkles , no more than 2 ml hyalu-ronic acid was injected into each side .All the participants were followed up at 1, 3, 6, and 12 months after the last injection and standardized photographs were taken at each visit .All the participants were asked to fill the form of local adverse events within the first 15 days after injection.Investigators and the participants both evalu-ated wrinkles based on Wrinkle Severity Rating Scale ( WSRS) .The WSRS score according to the pictures of 6 months post-injection were compared with the pictures which were taken before the injection ( baseline) by in-dependent staff at the end of the trial .One or more grades of WSRS improvement compared with the baseline was considered as effective .Laboratory tests including blood and urine routine , liver and renal function tests were carried out at screening visit and 6 months after injection.Results The baseline features between the two groups were comparable (all P>0.05).There was no significant difference in the WSRS 6 months after injec-tion between the two groups ( P>0.05 ) .There was no significant difference in the WSRS improvement com-pared with baseline between the two groups ( P=0.105 ) .There was no significant difference in the rate of ef-fectiveness between the two groups ( 93.0% vs.96.7%, P=0.431 ) .Two participants reported minor ad-verse events, although both of which might not be associated with the product or procedure .No laboratory test change was found during the trial .Conclusions No severe adverse event associated with the injection material was observed during this clinical trial .According to the result , Revanesse Ultra may have good histocompati-bility and tolerance .It could provide obvious improvement in the nasolabial folds , with effectiveness comparable to that of Restylane .
