Stephens Thomas J, Sigler Monya L, Hino Peter D, Moigne Anne Le, Dispensa Lisa
Thomas J. Stephens & Associates, Inc., Richardson, Texas;
Pfizer Consumer Healthcare, Madison, New Jersey.
J Clin Aesthet Dermatol. 2016 Apr;9(4):25-32. Epub 2016 Apr 1.
Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin.
Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. PARTICIPANTS utilized a standardized facial cleanser and SPF15 moisturizer.
Single study center (Texas, United States; June-November 2007).
Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II-III.
Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05).
Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed.
Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial photodamage.
Not applicable. Study precedes FDAAA 801 clinical trial registration and results submission requirements.
评估一种抗衰老护肤品对光损伤皮肤外观的影响。
随机、双盲、安慰剂对照临床试验。在为期1个月的洗脱期后，受试者每天服用两片抗衰老护肤配方片（每日总剂量：海洋复合物210毫克、维生素C 54毫克、锌4毫克）或安慰剂，持续16周。受试者不得使用可能影响皮肤状况/外观的产品/程序，包括面部直接日晒或使用晒黑床。参与者使用标准化的洁面产品和防晒系数为15的保湿霜。
单一研究中心（美国得克萨斯州；2007年6月至11月）。
年龄在35至60岁（平均50岁）的健康女性，菲茨帕特里克皮肤分型为I-IV型，改良Glogau分型为II-III型。
在第6周、12周和16周对受试者进行临床分级（0-10分视觉模拟评分）、生物仪器测量、数码摄影和自我评估。模型中采用含治疗因素的方差分析进行组间比较（α P≤0.05）。
82名服用抗衰老护肤配方片的受试者和70名服用安慰剂的受试者完成了研究。在从基线到第16周的评分变化方面，抗衰老护肤配方片组在整体面部外观临床分级（0.26；P<0.0001）、肤色光泽（0.59；P<0.0001）、眼周皱纹（0.08；P<0.05）、视觉粗糙度（0.56；P<0.0001）和触觉粗糙度（0.48；P<0.0001）以及斑驳性色素沉着（0.15；P<0.001）方面有显著差异，表明抗衰老护肤配方片组受试者情况更佳。与抗衰老护肤配方片组相比，安慰剂组的超声皮肤密度（第16周）显著降低（-1.4% 对 0%；P<0.01）。其他结果无显著差异。观察到可能与抗衰老护肤配方片（n = 1）和安慰剂（n = 2）相关的轻度胃肠道症状。
接受抗衰老护肤配方片的光损伤皮肤女性面部光损伤外观有显著改善。
不适用。本研究先于《食品药品监督管理局修正法案》第801条的临床试验注册及结果提交要求。
