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Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
Sponsor: NAOS Les Laboratoires
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. 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.
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 -
Key Details
Gender
All
Age Range
3 Months - 12 Years
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2024-09-02
Completion Date
2025-09-01
Last Updated
2025-01-06
Healthy Volunteers
No
Conditions
Interventions
Study product
Anti-itching, anti-replapse and repairing treatment. Emollient.
Placebo
Emollient
Locations (1)
EUROFINS
Gdansk, Poméranie, Poland