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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Anti-itching, anti-replapse and repairing treatment. Emollient.
Emollient
EUROFINS
Gdansk, Poméranie, Poland
RECRUITINGSCOring 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
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