NCT06756438Completed
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study vs Placebo -- Use Test Under Dermatological Control -
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 28 Nov 2024
- Start date
- 2 Sept 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- NAOS Les Laboratoires
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06756438
What you commit to
- Study type: Interventional
- Participants enrolled: 88
- From 2 Sept 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).
Other
- Cutaneous pathology on the study zone other than atopic dermatitis;
- Subject enrolled in another clinical trial during the study period (concerns the studied zones);
Who the study is looking for
- 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;
- 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.
Age in the registry: 3 months to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| EUROFINS Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.