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临床试验/NCT07793123
NCT07793123进行中(未招募)不适用

Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of an Oral Antioxidant Dietary Supplement on Skin Radiance in Women Exposed to Urban Air Pollution

Robertet SA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Skin Radiance

研究概览

简要总结

A randomized, double-blind, placebo-controlled study evaluating the effects of an oral antioxidant dietary supplement on skin radiance in women exposed to urban air pollution. Secondary assessments include skin tone homogeneity, pigmentation, inflammation, skin barrier function, glycation markers.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • Healthy female subjects aged 35 to 65 years.
  • Fitzpatrick skin phototype II to IV.
  • Any skin type.
  • Dull and uneven skin complexion.
  • Living in an urban environment and exposed to pollution.
  • No change in hormonal treatment within the past 3 months.
  • Able to understand the study procedures and provide informed consent.
  • Willing and able to comply with study requirements.
  • Written informed consent obtained.
  • Covered by health insurance.
  • Willing to avoid unprotected sun exposure and use SPF 50 sunscreen throughout the study.

排除标准

  • Pregnant or breastfeeding women, or women planning to become pregnant during the study.
  • Current use of dietary supplements or vitamin supplements.
  • Participation in another clinical trial involving a cosmetic product, drug, or medical device.
  • Use of oral or injectable corticosteroids within the past 3 months.
  • Current treatment with immunosuppressive agents, chemotherapy, or radiotherapy.
  • History of autoimmune disease or connective tissue disorder.
  • Presence of an active dermatological condition that could affect study assessments.
  • Following a vegetarian, vegan, or weight-loss diet.
  • Not covered by health insurance.
  • Participation in another clinical study during the exclusion period.
  • Individuals considered vulnerable according to applicable regulations.

研究组 & 干预措施

Dietary supplement : Placebo

Placebo Comparator

Maltodextrin = 400 mg/capsule, 1 capsule per day.

干预措施: Placebo (Dietary Supplement)

Dietary supplement : Investigational product

Active Comparator

1 capsule contains :140 mg Rosa damascena extract, 20 mg melon concentrate and 140 mg acerola extract; 57mg maltodextrin; 1 capsule per day.

干预措施: Antioxidant Supplement (Dietary Supplement)

结局指标

主要结局

Skin Radiance

时间窗: Day 0 and Day 90

Glossymeter

次要结局

  • Skin Radiance(Day 0 and Day 30)
  • Skin Radiance(Day 0, Day 30, Day 90)
  • Skin homogeneity(Day 0, Day 30, Day 90)
  • TransEpidermal Water Loss(Day 0, Day 30, Day 90)
  • Skin glycation(Day 0, Day 30, Day 90)
  • skin IL8(Day 0, Day 30, Day 90)

研究者

发起方
Robertet SA
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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