NCT07229131已完成不适用
Effect of an Oral Acerola Juice Powder on Skin Beauty Parameters in Women Exposed to Environmental Stresses: A Double-blind, Randomised, Placebo-controlled Study.
Diana SAS1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline on skin translucency parameter Alpha at 84 days
研究概览
简要总结
The study is being conducted to evaluate the efficacy and the safety of an oral acerola-based product on skin ageing parameters.
详细描述
The main objective of this study is to assess efficacy of the product on skin translucency after 84 days of product compared to a placebo. The study will also evaluate the effect of the product on different skin parameters (radiance, firmness, elasticity, skin barrier function, skin pH, blood flow) with different instruments. The quality of life and the improvement of skin properties will also be collected with questionnaires completed by the subjects. Finally, the safety of this product will be assessed by collecting all adverse events that might occur during the study.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women.
- •Age: in each group of products
- •50% of subject having 30 to 45 years old
- •50% of subject having 46 to 60 years old
- •Phototype: II to IV.
- •Subject with dull skin from grade 3 to 7 on skin dullness 9 points scale.
- •Subject exposed to high air pollution up to 2 to 3 hours per day (traffic roads, cigarette smoke, dusts or small particles).
- •Subject who accepts daily exposition to blue light (mobile phone, Ipad, laptop or get exposure to LED light) at home (at least 2h).
- •Subject with at least 1 spot on the face.
- •Subject with BMI ≤ 30
- •Subject, psychologically able to understand the study related information and to give a written informed consent.
- •Subject having given freely and expressly her informed consent.
- •Subject agreeing to not change her alimentary and cosmetic habits on the studied area during the study.
排除标准
- •In term of population :
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Minor subject.
- •Major subject who is under guardianship or who is not able to express her consent.
- •Subject in a social or sanitary establishment.
- •Subject suspected to be non-compliant according to the investigator's judgment.
- •In term of associated pathology :
- •Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
- •Subject suffering from a severe or progressive disease.
- •Subject with known history of or suffering from skin disease that may interfere with evaluation of the study results and/or subject safety.
- •Subject having history of severe allergy or anaphylactic shock including known risk of hypersensitivity to one of the components of the composition of the product
- •Related to previous or ongoing treatment :
- •Subject undergoing a topical treatment on the test area or a systemic treatment:
- •anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- •corticosteroids during the 2 previous weeks and during the study;
- •retinoids and/or immunosuppressors during the 3 previous months and during the study;
- •any medication stabilized for less than one month.
- •Subject having started or changed her oral contraceptive or any other hormonal treatment during the three previous months.
- •Subject having done facial skin care like peeling, mask… during the previous 2 weeks and during the study.
- •Subject having used oral nutritional supplements and/or vitamin supplementation during the previous month and during the study
- •In term of lifestyle :
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
- •Subject having used topical products containing actives substances during the previous 2 weeks and during the study
- •Subject planning to change her life habits during the study.
- •Subject with unstable eating habits or planning to change them during the study
- •Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 5 cigarettes per day).
研究组 & 干预措施
Acerola Juice Powder 1200 mg/day
Experimental
Higher dose
干预措施: Acerola Juice Powder 1200 mg/day (Dietary Supplement)
Acerola Juice Powder 600 mg/day
Experimental
Lower dose
干预措施: Acerola Juice Powder 600 mg/day (Dietary Supplement)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline on skin translucency parameter Alpha at 84 days
时间窗: From enrollment to 84 days of supplementation
The skin translucency parameter Alpha is measured with translucency meter
次要结局
- Change from baseline on skin translucency parameters Alpha, Area and K at 28 days and 84 days(From enrollment to 28 days of supplementation)
- Change from baseline on skin complexion radiance at 14, 28, 56 and 84 days(From enrollment to 14, 28, 56 and 84 days of supplementation)
- Change from baseline on pigment spot at 14, 28, 56 and 84 days(From enrollment to 14, 28, 56 and 84 days of supplementation)
- Change from baseline on skin firmness, elasticity and fatigability at 28 and 84 days(From enrollment to 28 and 84 days of supplementation)
- Change from baseline on Trans Epidermal Water Loss at 28 and 84 days(From enrollment to 28 and 84 days of supplementation)
- Product safety(From enrolment to 84 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Annurca Apple Peel Oleolite for the Treatment of Skin HyperpigmentationHyperpigmentationNCT07040345Ritamaria Di Lorenzo48
已完成
4 期
CaroRite™ for Skin Health and Signs of AgeingNCT06878001RDC Clinical Pty Ltd80
已完成
不适用
The Effect of Avocado vs. Usual Diet on Skin AgingSkin InflammationNCT05102604University of California, Los Angeles40
尚未招募
不适用
Effects of an Oral Herbal Supplement on Skin Aging, Hydration, and ElasticityPhotoagingNCT06146140Integrative Skin Science and Research36
已完成
不适用
A study for improving effects on the skin by a beauty beverage containing plant extractsHealthy adultsJPRN-UMIN000026482Kao Corporation20