The efficacy and safety of Dermalax^TM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study

Abstract

Background

To investigate the efficacy and safety of Dermalax in the correction of moderate to severe nasolabial folds (NLFs) compared to Restylane.

Methods

A total of 324 subjects with moderate to severe NLFs were enrolled in this multicenter, randomized, double-blind, active-controlled clinical study. Eligible subjects were randomly assigned to the test group received Dermalax injection (n = 162) or control group received Restylane injection (n = 162). Clinical efficacy and safety were assessed based on the Wrinkle Severity Rating Scale (WSRS) and the Global Esthetic Improvement Scale(GAIS) at weeks 2, 8, 16, 24, 36 and 48 weeks after injection.

Results

At week 24, similar improvements of effective rate were obtained on the Dermalax group (93.75%) and Restylane group (89.44%). Significances were found at 36 weeks and 48 weeks after injection, Dermalax seemed be better than Restylane in maintaining the effect in the later period. The improvement of mean WSRS score for test group was superior to that of control group with significance. GAIS scores rated at week 24 were 1.65 VS 1.94 (p < .001) and 2.10 VS 2.27 (p = .060), seperately.

Conclusions

Dermalax was no inferior to or better than that of the control filler Restylane in correcting of moderate to severe NLFs in Chinese subjects.

Keywords:

• Filler
• hyaluronic acid
• nasolabial fold
• clinical trial

Ethical approval

This study was performed according to the World Medical Association (WMA) Declaration of Helsinki under the Policy of “Ethical Principles for Medical Research Involving Human Subjects”. All patients provided informed consent and the protocols were under the approval by the Ethics Commission of the Institutional Review Board (No. HS2016026), Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Tongren Hospital affiliated to Capital Medical University, First Affiliated Hospital of Zhejiang University Medical College, Second Affiliated Hospital of Zhejiang University Medical College, West China Hospital of Sichuan University, Shanghai Dermatology Hospital, Dermatology Hospital of Chinese Academy of Medical Sciences.

Disclosure statement

Both drugs used and clinical costs for the study were provided by ACROSS Co., Ltd. The authors declare that no other conflict of interests exit.