The Effects of an L-histidine-Based Supplement, Eczema Topical, and Unscented Soap on Children With Eczema
2026年6月22日 更新者：Codex Labs Corporation
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
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).
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Gdansk、波兰
- Eurofins Dermscan Poland
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1 (ages 1-3 years)
The participant is provided with a daily powder supplement containing 0.8g of L-histidine, a topical oil to be used at least twice daily, and an unscented soap to be used twice daily.
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The intervention includes 3 products:
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实验性的：Group 2 (ages 4-12 years)
The participant is provided with daily gummy supplements containing 0.8g of L-histidine, a topical lotion to be used at least twice daily, and an unscented soap to be used twice daily.
|
The intervention includes 3 products: 1. Gummy supplements containing 0.8g of L-histidine.
2. A topical lotion to be used at least twice daily and as often as needed on the face and body.
3.
An unscented soap to be used twice daily (in the morning and evening) on the face and body, in replacement of the usual cleansing product.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
湿疹严重程度的客观和主观评分
大体时间：8周
|
使用Scorad（特应性皮炎的评分）评估了湿疹严重程度的变化。
答：首先，研究人员评估了湿疹在不同身体区域的传播，并计算为百分比，最高为100％。
B.第二，研究人员从0到3次，皮肤发红，肿胀，渗出痕迹，划痕，皮肤增厚和干燥的强度是对0，其中1个，1个轻度，2是中等的，3是严重的。
C.最后，对于主观评分，要求参与者报告从0到10的症状强度（瘙痒和失眠），其中0不痒或没有睡眠，而10个是最不可能想象的瘙痒或失眠症的最糟糕的睡眠。
用以下公式获得了客观刻板的总分数：scorad = a/5 + 7 b/2 + c
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8周
|
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湿疹严重程度的客观和主观评分
大体时间：4周
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使用Scorad（特应性皮炎的评分）评估了湿疹严重程度的变化。
答：首先，研究人员评估了湿疹在不同身体区域的传播，并计算为百分比，最高为100％。
B.第二，研究人员从0到3次，皮肤发红，肿胀，渗出痕迹，划痕，皮肤增厚和干燥的强度是对0，其中1个，1个轻度，2是中等的，3是严重的。
C.最后，对于主观评分，要求参与者报告从0到10的症状强度（瘙痒和失眠），其中0不痒或没有睡眠，而10个是最不可能想象的瘙痒或失眠症的最糟糕的睡眠。
用以下公式获得了客观刻板的总分数：scorad = a/5 + 7 b/2 + c
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4周
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Eczema Area Severity Index (EASI) score
大体时间：8 weeks
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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.
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8 weeks
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Eczema Area Severity Index (EASI) score
大体时间：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.
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Sleep
大体时间：8 weeks
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Parent/guardian will fill out the Children Sleep Habit's questionnaire for their child. This questionnaire inquires about bedtime, sleep behavior, waking during the night, and morning wake-up. Possible answers include: "Always", "Usually", "Sometimes", "Rarely", and "Never". "Always" is selected if a certain behavior occurs every night, "Usually" is selected if it occurs 5 or 6 times a week, "Sometimes" if it occurs 2 to 4 times a week, "Rarely" if it occurs once a week, and "Never" if it occurs less than once a week. |
8 weeks
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Quality of Sleep
大体时间：4 weeks
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Parent/guardian will fill out the Children Sleep Habit's questionnaire for their child. This questionnaire inquires about bedtime, sleep behavior, waking during the night, and morning wake-up. Possible answers include: "Always", "Usually", "Sometimes", "Rarely", and "Never". "Always" is selected if a certain behavior occurs every night, "Usually" is selected if it occurs 5 or 6 times a week, "Sometimes" if it occurs 2 to 4 times a week, "Rarely" if it occurs once a week, and "Never" if it occurs less than once a week. |
4 weeks
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Subjective Eczema Severity
大体时间：8 weeks
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Parent/guardian will fill out the Patient-Oriented Eczema Measure (POEM).
This includes 7 questions about the number of days over the last week that their child experienced certain symptoms of eczema.
Possible answers include: "No Days", "1-2 Days", "3-4 Days", "5-6 Days", or "Everyday".
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8 weeks
|
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Subjective Eczema Severity
大体时间：4 weeks
|
Parent/guardian will fill out the Patient-Oriented Eczema Measure (POEM).
This includes 7 questions about the number of days over the last week that their child experienced certain symptoms of eczema.
Possible answers include: "No Days", "1-2 Days", "3-4 Days", "5-6 Days", or "Everyday".
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4 weeks
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Emotional and Behavioral Questionnaire
大体时间：8 weeks
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Parent/guardian will fill out the Pediatric Symptom Checklist-17 (PSC-17) for their child.
It includes 17 questions that relate to how often a certain behaviors or mood occurs.
Answers include "Never", "Sometimes", "Often".
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8 weeks
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Emotional and Behavioral Questionnaire
大体时间：4 weeks
|
Parent/guardian will fill out the Pediatric Symptom Checklist-17 (PSC-17) for their child.
It includes 17 questions that relate to how often a certain behaviors or mood occurs.
Answers include "Never", "Sometimes", "Often".
|
4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月19日
初级完成 (实际的)
2026年3月31日
研究完成 (实际的)
2026年3月31日
研究注册日期
首次提交
2026年6月22日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月26日
研究记录更新
最后更新发布 (实际的)
2026年6月26日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- #STUU525AA1865
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Data will need to be protected for patentability reasons while IP is being filed.
Once IP considerations are finalized, data can be shared.
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不
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