Atopic Dermatitis (Eczema)NCT07670676

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

A study testing Powder Supplement + Topical Oil + Unscented Soap and Gummy Supplement + Topical Lotion + Unscented Soap in people with Atopic Dermatitis (Eczema), run by Codex Labs Corporation at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 1 year to 12 years
Conditions the study is for: Atopic Dermatitis (Eczema)
What is being tested?: Powder Supplement + Topical Oil + Unscented Soap and Gummy Supplement + Topical Lotion + Unscented Soap
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 sitePoland
Study dates: 19 Dec 2025to 31 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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;

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Eurofins Dermscan Poland
Gdansk

Other trials in Poland

About this study

Official title: 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

Conditions: Atopic Dermatitis (Eczema)
Being tested: Powder Supplement + Topical Oil + Unscented Soap, Gummy Supplement + Topical Lotion + Unscented Soap
Keywords: eczema, supplement, dry skin, lotion, l-histidine
Medical subject headings: Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Powder Supplement + Topical Oil + Unscented SoapOther
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.
Gummy Supplement + Topical Lotion + Unscented SoapOther
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.

Study groups in NCT07670676
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Gummy Supplement + Topical Lotion + Unscented Soap

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 weeks

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 202531 Mar 2026

First posted26 Jun 2026
Study start19 Dec 2025
Primary completion31 Mar 2026
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07670676
Sponsor's protocol ID: #STUU525AA1865
Status last verified: Jun 2026
First submitted: 22 Jun 2026
Last updated: 26 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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All Atopic Dermatitis (Eczema) trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07670676
Acronym / sponsor ID: #STUU525AA1865
Conditions: Atopic Dermatitis (Eczema)
Keywords: eczema, supplement, dry skin, lotion, l-histidine
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Codex Labs CorporationIndustry (pharma, biotech, devices)
Study start: 19 Dec 2025 (actual)
Primary completion: 31 Mar 2026 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 26 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 (ages 1-3 years)	Experimental	Other: Powder Supplement + Topical Oil + Unscented SoapThe 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.
Group 2 (ages 4-12 years)	Experimental	Other: Gummy Supplement + Topical Lotion + Unscented SoapThe 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.

Who may qualify

Ages: 1 year to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

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);

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Powder Supplement + Topical Oil + Unscented SoapThe 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.	Other	Group 1 (ages 1-3 years)
Gummy Supplement + Topical Lotion + Unscented SoapThe 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.	Other	Group 2 (ages 4-12 years)

Primary outcome

Objective and Subjective Scoring of Eczema Severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

6 secondary outcomes

Quality of Sleep
Time frame: 8 weeks
Quality of Sleep
Time frame: 4 weeks
Subjective Eczema Severity
Time frame: 8 weeks
Subjective Eczema Severity
Time frame: 4 weeks
Emotional and Behavioral Questionnaire
Time frame: 8 weeks
Emotional and Behavioral Questionnaire
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Individual participant dataSharing planned: No. Data will need to be protected for patentability reasons while IP is being filed. Once IP considerations are finalized, data can be shared.

Related trials for Atopic Dermatitis (Eczema)

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
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RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective and Subjective Scoring of Eczema Severity (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07670676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.