NCT05059197已完成不适用
Evaluation of Skin Health Improvement and Safety in AP Collagen Peptide: Randomized, Double-blind, Placebo-controlled
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change from baseline in epidermal hydration
研究概览
简要总结
This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those whose eye wrinkles are Grade 3 or higher in the visual evaluation
- •Those whose moisture retention in both cheeks measured by Corneometer® is 49 A.U. or less
- •A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
排除标准
- •Those with skin diseases such as atopic dermatitis and psoriasis
- •Those who are sensitive to or allergic to the food ingredients for this trial foods
- •Those with skin abnormalities such as spots, acne, erythema, and hypersensitive skin at the test site
- •People who take diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month based on visit1
- •Those who have used functional cosmetics for wrinkle improvement, highly moisturizing cosmetics, or skincare devices within 2 weeks of visit 1
- •A person who used steroid-containing outer skin for more than one month to treat skin diseases
- •A person who has received chemical and physical treatment (pattern, epidermis, lasers, procedures, etc.) in the test area within six months prior to the start of the test
- •Visit 1 A person who has participated in other interventional clinical tests (including human application tests) within one month of the standard or plans to participate in other interventional clinical tests (including human application tests) after the start of this human application test
- •A person who judges that the tester is inappropriate for this test
结局指标
主要结局
Change from baseline in epidermal hydration
时间窗: Baseline, 12 week
skin hydration measured by MoistureMeter-D compact
次要结局
- Change of Ceramides in stratum corneum(Baseline, 12 week)
- Change from baseline in TEWL(Baseline, 12 week)
- Change from baseline in stratum corneum condition(Baseline, 12 week)
- Change from baseline in skin roughness (texture)(Baseline, 12 week)
- Change from baseline in skin gloss(Baseline, 12 week)
- Change of Natural moisturizing factor in stratum corneum(Baseline, 12 week)
研究者
研究点 (2)
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