Clinical Efficacy Evaluation of a Supplement Combined With Eczema Lotion + Soap on Two Groups of Children Population Having Atopic Dermatitis- Use Test Under Dermatological Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 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 containing the amino acid, L-histidine, alongside a plant-biotech topical product, and an unscented bar soap on 2 age groups of children with mild to moderate atopic dermatitis (group 1: ages 1-3 years, group 2: 4-12 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: female and male;
- •Age : from 1 to 12 years old;
- •Phototype: I to IV;
- •Type: Caucasian;
- •Child having mild to moderate eczema and atopic dermatitis (including but not limited to flakiness, irritation, itching and dryness);
- •No change in hygiene, cosmetics - except for the product(s) under study - during the entire study duration;
- •Subjects/Subjects parent's agreeing not to change lifestyle habits of child during the study duration.
- •Healthy child;
- •Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent;
- •Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures;
- •Child with Polish citizenship.
排除标准
- •Cutaneous pathology on the study zone (other than atopic dermatitis);
- •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);
- •Child having undergone a surgery under general anesthesia within the previous month;
- •Excessive exposure to sunlight or UV-rays within the previous month;
- •Child enrolled in another clinical trial during the study period.
结局指标
主要结局
Objective and Subjective Scoring of Eczema Severity
时间窗: 8 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
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
Eczema Area Severity Index (EASI) score
时间窗: 8 weeks
Change in eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator at 4 body regions on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The EASI is the sum of these scores.
Eczema Area Severity Index (EASI) score
时间窗: 4 weeks
Change in eczema severity is assessed with the Eczema Area and Severity Index (EASI). Skin redness, elevation, scratching, and thickening are assessed by the investigator at 4 body regions on a scale of 0 to 3, where 0 is none, 1 is mild, 2 is moderate, 3 is severe. The EASI is the sum of these scores.
次要结局
- Quality of Sleep(8 weeks)
- Quality of Sleep(4 weeks)
- Subjective Eczema Severity(8 weeks)
- Subjective Eczema Severity(4 weeks)
- Emotional and Behavioral Questionnaire(8 weeks)
- Emotional and Behavioral Questionnaire(4 weeks)