可溶性透明质酸微针对眶下皱纹的改善作用

Efficacy of soluble hyaluronic acid microneedle on removing suborbital wrinkles

目的探讨可溶性透明质酸微针眼贴对眶下皱纹的临床疗效和安全性。方法于2018年4月至2018年9月招募北京、上海符合纳入标准女性受试者75例,于左下眼睑(试验侧)外用可溶性透明质酸微针眼贴固定至少30 min,每周2 d,连续使用12周。在使用前、4周、12周进行研究者视觉评估、仪器检测皮肤水分、弹性值、皱纹面积和深度,并与右侧(对照侧不用眼贴)进行对比。记录试验期间发生的不良反应评估其安全性,在12周评估受试者的满意度。结果可溶性透明质酸微针眼贴使用12周后,试验侧视觉皱纹评估(n=41,改善率54.67%)较对照侧(n=14,总改善率18.67%)明显改善。使用侧皮肤含水量随使用时间逐渐升高,(4周t=0.488,12周t=3.054,均P<0.05)。试验侧皮肤弹性在12周后显著增加,皮肤弹性改善率高于对照侧(t=2.724,P<0.05)。皱纹面积在4周后开始显著减少(4周t=4.442,12周t=3.802,均P<0.05);试验侧皱纹深度随使用时间延长变浅(4周t=-2.435,12周t=-3.433,P均<0.05)。仅8%(n=6)受试者使用侧出现暂时性轻微瘙痒或针刺感,无其他不良反应。受试者满意度88%(n=66)。结论可溶性透明质酸微针眼贴在改善皱纹、提高皮肤弹性和补充水分等方面有一定效果,使用方便无明显不良反应。

Objective To investigate the clinical efficacy and safety of soluble hyaluronic acid microneedle eye patch on infraorbital wrinkles.Methods Seventy-five female subjects in Beijing and Shanghai were recruited and treated with soluble hyaluronic acid microneedle patch two days a week at the left lower eyelid(experimental side)and at least 30 minutes each time for 12 weeks.Investigator visual assessment,instrumentation measurement for skin moisture,elasticity,wrinkle area and depth were performed at week 0(pre-treatment)and week 4 and week 12 and compared to the right(control side).The safety was assessed by documenting adverse reactions occurring during the study.Subject satisfaction was assessed at week 12.Results After 12 weeks of treatment,the visual assessment of skin wrinkles on experimental side(n=41,54.67%)was significantly improved as comparied with that on control side(n=14,18.67%).The skin hydration of treatment side skin increased with treatment time(t=-0.488 at week4,t=-3.054 at week 12,P<0.05).After 12 weeks of treatment,skin elasticity of the experimental side improved significantly.The improvement rate of the experimental side was more than that of the control side(t=2.724,P<0.05).The wrinkle area was significantly decreased in 4 and 12 weeks compared with pre-treatment(t=4.442 at week 4 and t=3.802 at week 12,P<0.001).The depth of wrinkles of the experimental side shallowed with the treatment(t=-2.435 at week 4 and t=-3.433 at week 12,P<0.05).Only 8%(n=6)of the subjects had temporary slight pruritus or acupuncture sensation on the treatment side,and no other adverse reactions occurred.The overall subject satisfaction rate was 88%(n=66).Conclusions Soluble hyaluronic acid microneedle eye patch is effective in improving wrinkles,skin elasticity and hydrating,and has no obvious adverse reaction.