Oral Sialic Acid Product Beauty Efficacy Test
2026年6月8日 更新者:Wuhan CASOV Green Biotech Co., Ltd
Assessment and Comparison on 3 Groups of 25 Human Beings of the Effect on the Cutaneous State, the Dermis Echogenicity, the Moisturizing Effect, the Depigmenting Effect, the Effect on the Biomechanical Properties and the Effect on Wrinkles, Color and Homogeneity and Pigmentary Spots of Cosmetic Product N°1 vs Cosmetic Product N°2 vs Placebo After Oral Intake in Conditions of Normal Use During 28, 56 and 84 Days: Self-assessment of the Cosmetic Qualities and Efficacy
Evaluate and compare the effects on female facial skin of oral placebo (Product A), N-acetylneuraminic acid (Product B), and ACAI-PLUS (Product C) after 28, 56, and 84 days under normal usage conditions.
研究概览
研究类型
观察性的
注册 (实际的)
83
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Hubei
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Wuhan、Hubei、中国、430071
- COSderma China Laboratory (Wuhan, China)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Chinese Asian women aged 40-65, with facial skin issues such as pigmentation spots, lack of elasticity, and wrinkles
描述
Inclusion Criteria:
- Skin type origin: Asian in China
- Age: from 40 to 65 years old
- Gender: female
Specific criteria:
• All skin type on the face Dry, dry combination, normal
presenting with a lack of elasticity to the face, inclusion grade
≤ 6 according 10 points scale
- presenting with a lack of density to the face, inclusion grade ≤ 6 according 10 points scale
- presenting with wrinkles on crow's feet area, grade ≥ 2 according to Skin ageing atlas Vol.2 (p.41)
- presenting with pigmentary spots with at least one with diameter ≥ 3mm
- Usual or occasional user of food supplements
- Able to give her informed consent
Exclusion Criteria:
The non-inclusion general criteria were the following ones:
- allergies or reactivity to cosmetic products,
- for the subjects undergoing hormonal treatment; change of treatment within 3 months preceding the inclusion visit,
- expectation of change in the current hormonal treatment during the study,
- anti-allergic, antibiotic, anti-inflammatory, dermatological treatment or corticosteroid therapy within 2 weeks before the inclusion visit,
- having a chronic pathology,
- performing or prevision to perform another test during the study or during the exclusion period,
- employee of the COSderma laboratory,
- pregnant or breast-feeding woman,
- woman not taking precaution to prevent pregnancy.
The non-inclusion specific criteria were the following ones:
- application of care products to the face within 48 hours preceding the inclusion visit,
- application of make-up products to the face the day of the inclusion visit,
- face wash with any other means than clear water (no soap or cleanser) on the day of the inclusion visit,
- application of self-tanning products to the face within 4 weeks preceding the inclusion visit,
- Oral intake of food supplement within 1 month preceding the inclusion visit,
- cutaneous marks on the face which could interfere with the skin's clinical signs assessment (pigmentation issues, scar tissues, over-developed hairiness, too many ephelides and naevi, sunburns...),
- solar exposition (natural sun or UVA or heliotherapy treatment) within 4 weeks preceding the inclusion visit and expectation of solar exposition (natural or UVA) during the study,
- Vitamin A acid treatment or its derivatives within 3 months preceding the pre-inclusion visit,
- Retinoid based oral treatment within 6 months before the pre-inclusion visit, or local treatment within 2 months prior to this visit,
- Carotene based treatment within 4 weeks preceding the inclusion visit,
- expectation or having undergone aesthetic or dermatological surgery on the face.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group A
placebo
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Oral placebo once daily for 84 consecutive days
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Group B
N-acetylneuraminic acid
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Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
|
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Group C
ACAI-PLUS
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Oral ACAI-PLUS, once a day, for 84 consecutive days
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Skin clinical scores
大体时间:Day0、Day28、Day56、Day84
|
Dermatologists use a 10-point scale (0-9) and Volume 2 of the Atlas of Skin Aging for visual/tactile assessment.
(includes elasticity, firmness, crow's feet, under-eye wrinkles, facial sagging, skin tone radiance, moisturization)
|
Day0、Day28、Day56、Day84
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-assessment by subjects
大体时间:Day0、Day28、Day56、Day84
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Subjects self-rated using a 10-point scale (0-9).
(includes skin beauty, visibility of wrinkles, skin tone evenness, radiance, firmness)
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Day0、Day28、Day56、Day84
|
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Dermal echo parameters
大体时间:Day0、Day28、Day56、Day84
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Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters
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Day0、Day28、Day56、Day84
|
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Color and clarity of spots
大体时间:Day0、Day28、Day56、Day84
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Dermatologists use Pantone color cards to score the color and clarity of spots
|
Day0、Day28、Day56、Day84
|
|
Wrinkles, skin tone uniformity, and spots
大体时间:Day0、Day28、Day56、Day84
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COSderma Photobench photography + Newtone software analysis to obtain information on wrinkles, skin tone uniformity, and spots
|
Day0、Day28、Day56、Day84
|
|
Stratum corneum moisture index
大体时间:Day0、Day28、Day56、Day84
|
Corneometer® CM825 capacitance measurement method to obtain Stratum corneum moisture index
|
Day0、Day28、Day56、Day84
|
|
Biomechanical properties of the skin
大体时间:Day0、Day28、Day56、Day84
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DTM310 Diastron® torque meter obtains information on skin biomechanical properties
|
Day0、Day28、Day56、Day84
|
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Freckle removal effect
大体时间:Day0、Day28、Day56、Day84
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Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects
|
Day0、Day28、Day56、Day84
|
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Self-assessment of cosmetic quality and efficacy
大体时间:Day28、Day56、Day84
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By distributing 12 questionnaires to the subjects, self-assessment information on the quality and effectiveness of cosmetics was obtained.
A four-point Likert scale was used (Agree, Somewhat Agree, Somewhat Disagree, Disagree), and the questionnaire content included: 1. Skin feels better; 2. Skin becomes fairer; 3. Pigmentation on the skin lightens or decreases; 4. Skin becomes radiant; 5. Skin becomes more elastic; 6. Skin is firmer than before; 7. Skin wrinkles and fine lines improve; 8. Skin becomes moisturized/hydrated; 9. Skin's oil-water balance is better; 10.
Skin looks rejuvenated, full of energy; 11.
Sleep improves after consumption; 12. Memory improves after consumption.
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Day28、Day56、Day84
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年9月25日
初级完成 (实际的)
2023年12月22日
研究完成 (实际的)
2023年12月22日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Luye Pharma Group Ltd.尚未招聘
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Academisch Medisch Centrum - Universiteit van Amsterdam...主动,不招人
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Mila (bMotion Technologies)完全的