The Effects of an L-histidine-Based Supplement, Eczema Topical, and Unscented Soap on Children With Eczema

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).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis (Eczema)
• Intervention / Treatment: Other: Powder Supplement + Topical Oil + Unscented Soap; Other: Gummy Supplement + Topical Lotion + Unscented Soap

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdansk, Poland
    • Eurofins Dermscan Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Powder Supplement + Topical Oil + Unscented Soap; The intervention includes 3 products: A powder dietary supplement containing 0.8g of L-histidine to be mixed with food or liquid of choice.; A topical oil to be used at least twice daily and as often as needed on the face and body.; 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.
Experimental: 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.	Other: Gummy Supplement + Topical Lotion + Unscented Soap; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective and Subjective Scoring of Eczema Severity	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	8 weeks
Objective and Subjective Scoring of Eczema Severity	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	4 weeks
Eczema Area Severity Index (EASI) score	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.	8 weeks
Eczema Area Severity Index (EASI) score	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Sleep	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
Quality of Sleep	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
Subjective Eczema Severity	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".	8 weeks
Subjective Eczema Severity	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".	4 weeks
Emotional and Behavioral Questionnaire	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".	8 weeks
Emotional and Behavioral Questionnaire	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

Collaborators and Investigators

• Sponsor: Codex Labs Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: eczema; supplement; dry skin; lotion; l-histidine
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; Lipids; Oils
• Other Study ID Numbers: #STUU525AA1865

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No