Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
Eligible age
0.3–12 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: NAOS Les Laboratoires
You may qualify if…
- ✓ 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;
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 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).
Source: ClinicalTrials.gov · NCT06756438 · last updated 2025-01-06