The Effects of an L-histidine-Based Supplement, Eczema Topical, and Unscented Soap on Children Wi… (NCT07670676) | Clinical Trial Compass
CompletedNot Applicable
The Effects of an L-histidine-Based Supplement, Eczema Topical, and Unscented Soap on Children With Eczema
Poland40 participantsStarted 2025-12-19
Plain-language summary
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).
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective and Subjective Scoring of Eczema Severity
Timeframe: 8 weeks
2
Objective and Subjective Scoring of Eczema Severity