Efficacy and Tolerance Evaluation of "Nutrakos®" Amino Acid Food Supplement (Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline of superficial skin hydration
研究概览
简要总结
Skin moisturizing and elasticizing efficacy of an amino acid food supplement
详细描述
Primary end point of this study was to evaluate the moisturizing and elasticizing activity of "Nutrakos®" Amino Acid Food Supplement, both photoexposed and not photoexposed on skin areas (forearm volar and dorsal surface) by non-invasive instrumental measurements; the product will be tested for 1 month by female subjects, aged 35-70 years with skin photoaging. An additional aim of this study was to evaluate the product tolerance both by investigator and volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex,
- •35-70 years,
- •skin phototype II and III according to Fitzpatrick's classification (see par. 8.2.1)
- •accepting to not change their habits regarding food, physical activity, body cosmetic and cleansing products;
- •accepting not to expose their body to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study;
- •accepting to sign the informed consent form.
排除标准
- •Pregnancy;
- •lactation;
- •alcohol or drug abusers;
- •skin phototype I, IV, V and VI according to Fitzpatrick's classification
- •subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •subjects not in menopause who do not accept to perform the pregnancy test at T0 and at the end of the study (T1M);
- •Body Mass Index (BMI) variation (± 1) during the study period;
- •change in the normal habits regarding food, physical activity, body cosmetic and cleansing use during the month preceding the test;
- •sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
- •subjects whose insufficient adhesion to the study protocol is foreseeable;
- •participation in a similar study currently or during the previous 6 months;
- •dermatitis;
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- •clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
- •diabetes;
- •endocrine disease;
- •hepatic disorder;
- •renal disorder;
- •cardiac disorder;
- •pulmonary disease;
- •neurological or psychological disease;
- •inflammatory/immunosuppressive disease;
- •drug allergy;
- •anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year before the study);
- •using of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
Nutrakos®
12 female subjects aged 35-70, have taken during a meal, for the 1 month ,2 stick packs/die of the food supplement
干预措施: Nutrakos® (Dietary Supplement)
结局指标
主要结局
Change from baseline of superficial skin hydration
时间窗: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Skin electrical capacitance value was measured mono-laterally on the right or left forearm (volar and dorsal surface) with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
Change from baseline of skin plastoelasticity
时间窗: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Superficial and deep skin plastoelasticity were measured mono-laterally on the right or left forearm (volar and dorsal surface) with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
Change from baseline of deep skin hydration
时间窗: Basal visit (T0), 2 weeks (T2W), 1 month (T1M)
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left forearm (volar and dorsal surface) with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
次要结局
- Change from baseline of tolerance(Basal visit (T0), 2 weeks (T2W), 1 month (T1M))