Atopic DermatitisNCT06756438
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
A study testing Study product in people with Atopic Dermatitis and Eczema, run by NAOS Les Laboratoires at 1 site in Poland.
Trial summary
Atopic eczema is a chronic inflammatory skin disease, mainly affecting children, characterized by itching and flare-ups. It results from genetic and environmental factors, leading to immunological and cutaneous abnormalities. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Study product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- 2 Sep 2024to 1 Sep 2025
- 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Specific
- Sex: female and/or male;
- Age: from 3 months up to 12 years old;
- Phototype: I to IV;
- 100% with atopic skin;
- 100% with sensitive skin;
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- Subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6 months before start of the study, including the crisis observed on D-X.
- Subject presenting on the visit D-X a flare-up of eczema for which the dermatologist prescribed treatment with topical corticosteroids treatment;
- Subjects with SCORAD between 15 and 40 on D-X;
- Subject who do not require medical treatment anymore after using prescribed topical corticosteroids from D-X up to D0 and clinical signs of atopic dermatitis are resolved, to be defined on D0 visit (in case of insufficient healing of inflammatory lesions, the subject continues medical treatment as recommended by the investigator).
- General
- Healthy subject;
- 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;
- 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 efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on D-X and in case of flare-up during the study course);
- Subject having undergone a surgery under general anesthesia within the previous month;
- Excessive exposure to sunlight or UV-rays within the previous month;
- Subject enrolled in another clinical trial during the study period (concerns the studied zones);
- Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study vs Placebo -- Use Test Under Dermatological Control -
Atopic eczema is a chronic inflammatory skin disease, mainly affecting children, characterized by itching and flare-ups. It results from genetic and environmental factors, leading to immunological and cutaneous abnormalities.
The aim of this study is to assess the efficacy of a product for atopic skin versus a placebo. Primary objectives include assessing the number, the delay and severity of recurrences of atopic dermatitis (measured by the SCORAD score), and the evolution of symptoms such as dryness and pruritus. Secondary objectives include quality of life and quality of sleep and skin acceptability.
The study protocol is a multicenter, double-blind, randomized clinical trial, in which participants receive either the study product or a placebo, while continuing their topical corticosteroid treatment.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Study product, Placebo
- Keywords
- ATOPIC DERMATITIS, Eczema, Dermocosmetic
- 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.
Study productOther
Anti-itching, anti-replapse and repairing treatment. Emollient.
PlaceboOther
Emollient
| Study group | Role | What they receive |
|---|---|---|
| Amr 1: Study product | Experimental | Product 1: Study product, Emollient. Face and body Receives: Other: Study product |
| Arm 2: Placebo | Placebo comparator | Product 2: Placebo, Emollient. face and body Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCOring Atopic Dermatisis (SCORAD)
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
Measured: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
SCORING ATOPIC DERMATITIS BY SUBJECT'S PARENT/LEGAL GUARDIAN (PO-SCORAD)
The PO-SCORAD ( Patient-Oriented SCOring Atopid Dermatisis) scale ranges from a minimum score of 0 to a maximum score of 75, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
Measured: Before (Day -X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
CUTANEOUS ACEPTABILITY
The product's capacity to maintain human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist in charge of the study to assess each following parameters : erythema, edema, dryness, desquamation, roughness, fonctional and physical signs.
Measured: On Day 0, Month 2, Month 4 and Month 6 of the product use, the body and face of the subject is examined by the dermatologist in charge of the study.
Evaluation of "xerosis", "pruritus" and "insomnia" evolution based on SCORAD
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
Measured: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start2 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted under a double-blind, randomized, multicenter, before-and-after, parallel-group design. Participants received either the test product or a placebo, while continuing topical corticosteroid treatment in combination or as a relay.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- NAOS Les Laboratoires
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756438
- Sponsor's protocol ID
- RC2024PSaib+PL
- Status last verified
- Oct 2026
- First submitted
- 28 Nov 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study vs Placebo -- Use Test Under Dermatological Control -
- ClinicalTrials.gov ID
- NCT06756438
- Acronym / sponsor ID
- RC2024PSaib+PL
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- ATOPIC DERMATITIS, Eczema, Dermocosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- NAOS Les LaboratoiresIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Jan 2025 (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.
Atopic eczema is a chronic inflammatory skin disease, mainly affecting children, characterized by itching and flare-ups. It results from genetic and environmental factors, leading to immunological and cutaneous abnormalities.
The aim of this study is to assess the efficacy of a product for atopic skin versus a placebo. Primary objectives include assessing the number, the delay and severity of recurrences of atopic dermatitis (measured by the SCORAD score), and the evolution of symptoms such as dryness and pruritus. Secondary objectives include quality of life and quality of sleep and skin acceptability.
The study protocol is a multicenter, double-blind, randomized clinical trial, in which participants receive either the study product or a placebo, while continuing their topical corticosteroid treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study was conducted under a double-blind, randomized, multicenter, before-and-after, parallel-group design. Participants received either the test product or a placebo, while continuing topical corticosteroid treatment in combination or as a relay.
| Arm | Type | Receives |
|---|---|---|
| Amr 1: Study product | Experimental | Other: Study productProduct 1: Study product, Emollient. Face and body |
| Arm 2: Placebo | Placebo comparator | Other: PlaceboProduct 2: Placebo, Emollient. face and body |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Specific
- Sex: female and/or male;
- Age: from 3 months up to 12 years old;
- Phototype: I to IV;
- 100% with atopic skin;
Key exclusion criteria (6 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 efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on D-X and in case of flare-up during the study course);
- Subject having undergone a surgery under general anesthesia within the previous month;
- Excessive exposure to sunlight or UV-rays within the previous month;
- Subject enrolled in another clinical trial during the study period (concerns the studied zones);
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 |
|---|---|---|
| Study productAnti-itching, anti-replapse and repairing treatment. Emollient. | Other | Amr 1: Study product |
| PlaceboEmollient | Other | Arm 2: Placebo |
Primary outcome
SCOring Atopic Dermatisis (SCORAD)
Time frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
SCORING ATOPIC DERMATITIS BY SUBJECT'S PARENT/LEGAL GUARDIAN (PO-SCORAD)
Time frame: Before (Day -X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The PO-SCORAD ( Patient-Oriented SCOring Atopid Dermatisis) scale ranges from a minimum score of 0 to a maximum score of 75, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
CUTANEOUS ACEPTABILITY
Time frame: On Day 0, Month 2, Month 4 and Month 6 of the product use, the body and face of the subject is examined by the dermatologist in charge of the study.
The product's capacity to maintain human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist in charge of the study to assess each following parameters : erythema, edema, dryness, desquamation, roughness, fonctional and physical signs.
Evaluation of "xerosis", "pruritus" and "insomnia" evolution based on SCORAD
Time frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
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 16 Oct 2026.
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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?
A study testing Study product in people with Atopic Dermatitis and Eczema, run by NAOS Les Laboratoires at 1 site in Poland.
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 15 inclusion and 6 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 16 Oct 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. Some participants in this study may receive a placebo. 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?
SCOring Atopic Dermatisis (SCORAD) (time frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)). 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?
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 16 Oct 2026.