Stephens Thomas J, Sigler Monya L, Herndon James H, Dispensa Lisa, Le Moigne Anne
Thomas J. Stephens and Associates, Inc., Richardson, TX, USA.
Dermatology Center of Dallas, Dallas, TX, USA.
Clin Cosmet Investig Dermatol. 2016 Mar 15;9:63-70. doi: 10.2147/CCID.S98787. eCollection 2016.
To assess the efficacy of Imedeen Time Perfection for improving the appearance and condition of photoaged skin in healthy women.
This randomized, double-blind, placebo-controlled clinical trial enrolled healthy women, 35-60 years of age, with Fitzpatrick I-III and Glogau II-III skin types and mild-to-moderate facial fine lines/wrinkles. The eligible subjects were randomized to receive two tablets daily of either Imedeen Time Perfection (Imedeen) or a matching placebo for 12 weeks. Efficacy assessments included investigator rating of 16 photoaging parameters (ie, global facial appearance and 15 individual facial parameters and the average of all parameters), instrumentation (ie, ultrasound dermal density, moisture level of the stratum corneum, transepidermal water loss, cutometry), and subjects' self-assessment. Differences in the mean change from baseline to week 12 values on these outcomes were compared between Imedeen and placebo using analysis of variance or a paired t-test.
Seventy-four subjects with primarily Fitzpatrick skin type III (78%-79%) and Glogau type III (53%-58%) completed the study (Imedeen: n=36; placebo: n=38). The mean difference in change from baseline to week 12 for global facial assessment significantly favored Imedeen over placebo (-0.52; P=0.0017). Additionally, the mean differences in the average of all facial photoaging parameters (-0.29), mottled hyperpigmentation (-0.25), tactile laxity (-0.24), dullness (-0.47), and tactile roughness (-0.62) significantly favored Imedeen over placebo (P≤0.05). Significantly greater increases in ultrasound dermal density (+11% vs +1%; P≤0.05) and stratum corneum moisturization (+30% vs +6%; P≤0.05) were also observed for Imedeen than for placebo. There were no significant differences on other instrumental outcomes.
The results of this study suggest that Imedeen Time Perfection can positively affect the appearance of photoaged skin, moisturization, and skin density over 12 weeks of treatment.
评估伊美婷时光完美系列产品对改善健康女性光老化皮肤外观及状况的疗效。
这项随机、双盲、安慰剂对照临床试验纳入了年龄在35至60岁之间、皮肤类型为菲茨帕特里克I - III型和格洛高II - III型且有轻度至中度面部细纹/皱纹的健康女性。符合条件的受试者被随机分为两组，每天服用两片伊美婷时光完美系列产品（伊美婷）或匹配的安慰剂，为期12周。疗效评估包括研究者对16项光老化参数的评分（即整体面部外观、15项个体面部参数以及所有参数的平均值）、仪器测量（即超声皮肤密度、角质层水分含量、经表皮水分流失、皮肤弹性测量）以及受试者的自我评估。使用方差分析或配对t检验比较伊美婷组和安慰剂组在这些指标上从基线到第12周平均值变化的差异。
74名主要为菲茨帕特里克III型皮肤（78% - 79%）和格洛高III型皮肤（53% - 58%）的受试者完成了研究（伊美婷组：n = 36；安慰剂组：n = 38）。在整体面部评估中，从基线到第12周变化的平均差异显著有利于伊美婷组而非安慰剂组（-0.52；P = 0.0017）。此外，在所有面部光老化参数的平均值（-0.29）、斑驳色素沉着（-0.25）、触觉松弛度（-0.24）、暗沉（-0.47）和触觉粗糙度（-0.62）方面，平均差异也显著有利于伊美婷组而非安慰剂组（P≤0.05）。与安慰剂相比，伊美婷组在超声皮肤密度（+11%对 +1%；P≤0.05）和角质层保湿（+30%对 +6%；P≤0.05）方面也有显著更大的提升。在其他仪器测量结果上没有显著差异。
本研究结果表明，在为期12周的治疗中，伊美婷时光完美系列产品可对光老化皮肤外观、保湿及皮肤密度产生积极影响。
