High Total Antioxidant Capacity (TAC) Products Added to Diet: Clinical and Instrumental Evaluation of Their Effect on Skin Surface Parameters and on Photo-induced Acute Damage of the Skin (Double Blind Clinical Study vs Placebo)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Erythema evaluation (MED-optical densitometry)
研究概览
简要总结
The purpose of this study is to evaluate the antioxidant activity on skin photo induced damage of a food supplement and its anti-age properties.
详细描述
To determine the antioxidant activity of the tested product the following clinical and instrumental evaluations will be performed:
- Evaluation of experimentally induced erythema inhibition: in basal conditions, before starting the assumption of the test product/placebo, and at T4, T8, T12, T16 weeks, each volunteer wll be exposed at the level of dorsal skin to six incremental doses of UVR (ultraviolet radiations mJ/cm2 ) in order to determine the MED (minimal erythema dose of unprotected skin). 20+/-4 hours after the UV exposure clinical and instrumental (optical densitometry) evaluations of skin erythema and photographic documentation (only on 16 preselected cases) will be performed.
- Blood samples collection for the determination of the principal antioxidants concentration (for example: lutein, carotene, lycopene and E vitamin): at T0, T4, T8 and T12 blood samples (5 ml of venous blood) will be collected on each volunteer by the Medical Staff. The samples will be sent to an external laboratory for haematologic control task.
To determine the anti-age properties of the tested product the following clinical and instrumental evaluations will be performed:
- Non Invasive, instrumental evaluation of principal skin parameters: epicutaneous pH, skin hydration (skin electrical capacitance), skin firmness (plastoelasticity), skin texture (skin surface irregularity index - FFT on skin replicas) measurements will be performed at T0 and T8 mono-laterally at level of volar forearm medium third, left or right side according to a previously defined randomization list.
- Clinical pictures with UV flash (Wood's light): at T0 and T8, 20 preselected cases of fairy skinned volunteers (selected on the basis of clinical ananmnesis regarding photosensitivity) will be submitted to the realization of clinical pictures at the level of the face using a special UV flash, able to highlight melanin spots, even if not yet visible at the naked eye.
Moreover aim of the study is also to evaluate the best dosage of the beverage (1 or 2 servings of 250 ml/a day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult volunteers of both sexes, between 30 and 60 years of age
- •Phototype II or III ( Fitzpatrick's classification)
- •Volunteers in a good general state of health in the Investigator opinion
- •Volunteers not taking drugs or undergoing surgical procedure
- •Volunteers who are giving a written informed consent
排除标准
- •pregnancy
- •lactation
- •smoking >10 cigarettes per day
- •drinking more then one glass of wine per day
- •drinking super-alcoholics
- •assumption of food supplement
- •change in the normal habits in the last month
- •participation in a similar study during the previous 3 months
- •insufficient adhesion to the study protocol
- •dermatological disease
- •clinical and significant skin condition on the test area (e.g. lesions, scars,malformations)
- •endocrine disease
- •hepatic, renal or cardiac disorder
- •topical drugs or surgical procedure on the test areas during the previous 3 months
- •systemic corticosteroids
- •aspirin or non-steroid anti-inflammatory drugs (FANS)
- •diuretic drugs
- •antibiotics and chemotherapics
- •psychotropic drugs
- •retinoids
- •psoralens
- •cardiologic and vascular drugs
研究组 & 干预措施
Group 1 Product 825 (2-servings day)
30 subjects drinking 2 servings day of Product 825 for 8 weeks
干预措施: Alixir - Pomegranate, apple and Açai drink / Placebo (Dietary Supplement)
Group 1 Product 824 (2 servings-day)
30 subjects drinking 2 servings-day of Product 824 for 8 weeks
干预措施: Alixir - Pomegranate, apple and Açai drink / Placebo (Dietary Supplement)
Group 2 Product 825 (1 serving-day)
30 subjects drinking 1 serving-day of Product 825 for 8 weeks
干预措施: Alixir - Pomegranate, apple and Açai drink / Placebo (Dietary Supplement)
Gruop 2 Product 824 (1 serving-day)
30 subjects drinking 1 serving-day of Product 824 for 8 weeks
干预措施: Alixir - Pomegranate, apple and Açai drink / Placebo (Dietary Supplement)
结局指标
主要结局
Erythema evaluation (MED-optical densitometry)
时间窗: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment), T12 and T16 (follow-up visits - 12 and 16 weeks after T0)
次要结局
- Skin evaluations (Skin texture - Hydration - Plastoelasticity - Epicutaneous pH)(T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis)
- Determination on blood samples of antioxidants diet components(T0 and T8 for skin evaluations - T0, T4, T8 and T12 for blood analysis)