此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

    • Hubei
      • Wuhan、Hubei、中国、430071
        • COSderma China Laboratory (Wuhan, China)

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

    1. presenting with a lack of elasticity to the face, inclusion grade

      ≤ 6 according 10 points scale

    2. presenting with a lack of density to the face, inclusion grade ≤ 6 according 10 points scale
    3. presenting with wrinkles on crow's feet area, grade ≥ 2 according to Skin ageing atlas Vol.2 (p.41)
    4. 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
Oral placebo once daily for 84 consecutive days
Group B
N-acetylneuraminic acid
Oral N-acetylneuraminic acid, once daily, for 84 consecutive days
Group C
ACAI-PLUS
Oral ACAI-PLUS, once a day, for 84 consecutive days

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
Subjects self-rated using a 10-point scale (0-9). (includes skin beauty, visibility of wrinkles, skin tone evenness, radiance, firmness)
Day0、Day28、Day56、Day84
Dermal echo parameters
大体时间:Day0、Day28、Day56、Day84
Using Dermcup® high-frequency B-mode ultrasound scanning (25 MHz probe) to obtain dermal echo parameters
Day0、Day28、Day56、Day84
Color and clarity of spots
大体时间:Day0、Day28、Day56、Day84
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
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
DTM310 Diastron® torque meter obtains information on skin biomechanical properties
Day0、Day28、Day56、Day84
Freckle removal effect
大体时间:Day0、Day28、Day56、Day84
Siascope V® spectrophotometric intradermal analysis obtains information on freckle removal effects
Day0、Day28、Day56、Day84
Self-assessment of cosmetic quality and efficacy
大体时间:Day28、Day56、Day84
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.
Day28、Day56、Day84

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

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

健康行为的临床试验

Oral placebo的临床试验

订阅