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

NCT07670676 | Completed

• 1 other identifier: #STUU525AA1865
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atopic Dermatitis (Eczema)

Keywords

eczema; supplement; dry skin; lotion; l-histidine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

Group 1 (ages 1-3 years)

EXPERIMENTAL

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

Group 2 (ages 4-12 years)

EXPERIMENTAL

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

Interventions

Powder Supplement + Topical Oil + Unscented Soap OTHER

The intervention includes 3 products: 1. A powder dietary supplement containing 0.8g of L-histidine to be mixed with food or liquid of choice. 2. A topical oil 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.

Group 1 (ages 1-3 years)

Gummy Supplement + Topical Lotion + Unscented Soap OTHER

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.

Group 2 (ages 4-12 years)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Codex Labs Corporation: lead

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Oils

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: December 19, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)