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.
⁃ 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.