| Objective: To evaluate the effectiveness and safety of a new injectable sodium hyaluronate gel in the treatment of moderate to severe neck wrinkles,and to provide a new material for clinical neck wrinkle treatment.Methods: 1.A total of 60 subjects participated in this clinical trial from December 2021 to August 2022.Subjects were screened by blinded investigators with reference to the Allergan Transverse Neck Scale(ATNLS)and all scored 2-3 on the Transverse Neck Scale.This study adopt a block-randomized,subject and evaluator-blinded,positive-controlled,non-inferiority design,with subjects assigned to the test and control groups in a 1:1 ratio.The test group was injected with a new injectable sodium hyaluronate gel,and the control group was injectable sodium hyaluronate complex solution(trade name: hi body).2.The experiment consisted of three injections,each at an interval of 15±5 days.Medical photographs were taken before the injection and at 1,3 and 6 months after the last injection.3.Neck wrinkles were scored by a third-party researcher before and at 1st,3rd and6 th months after the last injection through photos,according to the ATNLS.And the rate of improvement in neck wrinkles at 1st,3rd and 6th month after the last injection(at least one grade of improvement in neck wrinkles compared to the initial period)was the main evaluation index of this study;subjects and investigators rated the overall improvement effect at the 1st,3rd and 6th month after the last injection with reference to the Global aesthetic improvement scale;subjects rated their satisfaction at the 1st,3rd and 6th month after the last injection;adverse events were recorded during the treatment.4.SPSS26.0 statistical software was applied for statistical analysis.The measurement data were expressed as mean±standard deviation(x±s)using t-test/corrected t-test,the count data were expressed as rate(%)using chi-square test/continuity corrected/Fisher exact test,and the ordered categorical data used Mann-whitney rank sum test,and P<0.05 was considered to have statistically significant difference in this study.Results:1.Among the 60 subjects,a total of 4 cases were dropped out from the trial,27 cases were actually enrolled in the trial group and 29 cases were actually enrolled in the control group.2.The response rate of the test group was 74.07% at 1st month after injection,59.26% at 3rd month,and 37.04% at 6th month.In the control group,the response rate was 93.10% at 1st month after injection,86.21% at3 rd month,and 75.86% at 6th month.3.The global aesthetic improvement scale scores of the subjects and the injectors were basically the same: a significant difference in global aesthetic improvement was found between the test and control groups at 1st month,3rd month and 6th month after treatment.In experimental group there was no significant difference between 3rd month and 1st month post treatment,just as 6th month to 3rd month post treatment.In the control group global cosmetic improvement at 3rd month post treatment was slightly worse compared to 1st month,but no significant difference at 6th month compared to 3rd month.4.In terms of safety,adverse events such as erythema,pinpoint bleeding,edema tend to disappear in 1 to 3 days,bruising and hyperpigmentation completely disappear in 5 to 10 days,and rare streak formation does not last longer than 15 days.No serious adverse events related to the product were observed in either group.5.Subject satisfaction was high for both types of products.Conclusions: Both products show certain effectiveness in the treatment of moderate to severe neck wrinkles,and the difference in response rate between the two is not significant at 1st month after injection.Nevertheless,the response rate of the hi body is significantly higher than that of the new injectable sodium hyaluronate gel 3rd month and 6th month post treatment.The duration of efficacy of hi body is more than half a year,while the new sodium hyaluronate gel for injection last only a few months.There were no serious adverse reactions associated with the product in either group,demonstrating a high level of safety in both. |
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