Clinical and Instrumental Efficacy Evaluation Of Oral Prebiotic + Synbiotic Food Supplement Tested With Topical Lotion + Soap On Subjects With Atopic Dermatitis- Use Test Under Dermatological Control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Objective and Subjective Scoring of Eczema Severity
研究概览
简要总结
The purpose of this study is to examine the effects of 2 dietary supplements (an oral prebiotic and an oral synbiotic) in combination with a topical lotion, and an unscented soap on eczema severity, various skin measures (such as skin hydration), and mood in those with eczema.
A prebiotic supplement contains ingredients that can get broken down by the bacteria in the gut.
A synbiotic supplement contains prebiotic and probiotic ingredients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: female and male;
- •Age : 18 years old and above;
- •Phototype: I to IV;
- •Type: Caucasian;
- •Subjects with active eczema condition the body (showing flakiness, irritation, itch and intense dryness);
- •Subjects with a SCORAD of 25 - 50;
- •Local EASI score of 0-15:
- •30% - 4-5
- •30% - 8-9
- •Subjects with dry and very dry skin on the study areas (cutaneous hydration rate < 50 A.U);
- •Subjects must not take antibiotics and / or apply any antifungal treatments (body/scalp) for 1 month before study start and during the entire study duration;
- •No change in hygiene, cosmetics, and make-up habits - except for the product(s) under study - during the entire study duration;
- •Subjects agreeing not to change lifestyle habits during the study duration
- •Healthy subject;
- •Subject having given her free informed, written consent;
- •Subject willing to adhere to the protocol and study procedures;
- •Subject with Polish citizenship.
排除标准
- •For women with childbearing potential: pregnant or nursing woman or woman planning to get pregnant during the study;
- •Cutaneous pathology on the study zone (other than eczema);
- •Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability/efficacy of the study product (the subjects are allowed to use their topical corticosteroids during the study if needed; the information about the treatment and the number of applications must be noted in the daily log);
- •Subject having undergone a surgery under general anesthesia within the previous month;
- •Excessive exposure to sunlight or UV-rays within the previous month;
- •Subject enrolled in another clinical trial during the study period (concerns the studied zones).
结局指标
主要结局
Objective and Subjective Scoring of Eczema Severity
时间窗: 4 weeks
Change in eczema severity was assessed using SCORAD (SCOring of Atopic Dermatitis). A. First, the spread of eczema on different body areas is assessed by the investigator and calculated as a percent, where the maximum is 100%. B. Second, the intensity of skin redness, swelling, oozing, scratch marks, skin thickening and dryness is scored by the investigator from 0 to 3, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. C. Finally, for the subjective score, participants are asked to report the intensity of symptoms (itch and sleeplessness) from 0 to 10, where 0 is no itch or no sleeplessness, and 10 is the worst imaginable itch or insomnia sleeplessness. The total score of the objective SCORAD is obtained with the following formula: SCORAD = A/5 + 7 B/2 + C
Localized Eczema Severity
时间窗: 4 weeks
Change in localized eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The localized EASI is the sum of these scores.
次要结局
- Skin Hydration(8 weeks)
- Transepidermal Water Loss(8 weeks)
- Desquamation Index(8 weeks)
- Positive and Negative Affect(8 weeks)