NCT01787461已完成4 期
Randomized, Double-blind, Placebo Controlled Trial Assessing The Effects Of An Oral Dietary Supplement Containing Marine And Plant Extracts On Overall Facial Skin Appearance Among Healthy Adult Women With Photo-aged Skin
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
研究概览
简要总结
The study hypothesis is that Imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In general good health and have no contraindications to the study product; Have Fitzpatrick Skin Type I-IV as determined by a trained evaluator. Have Glogau Classification of Photoaging of II or III as determined by the investigator.
排除标准
- •Use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline.
- •History of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases).
- •Subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Imedeen
Experimental
Imedeen is the study product
干预措施: Imedeen (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24
时间窗: Baseline, Week 24
IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (\<=) 3 signifies Mild; greater than (\>) 3 to \<=6 signifies Moderate and \>6 to \<=9 signifies Severe.
次要结局
- Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)(Baseline, Week 6, 12, 18, 24)
- Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24(Baseline, Week 12, 24)
- Participants Improvement Assessment of Face at Week 12 and 24(Baseline, Week 12, 24)
- Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24(Baseline, Week 6, 12, 18, 24)
- Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24(Baseline, Week 6, 12, 18, 24)
- Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24(Week 24)
- Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12(Baseline, Week 12)
- Change From Baseline in Skin Thickness at Week 6, 12,18 and 24(Baseline, Week 6, 12, 18, 24)
研究者
研究点 (4)
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