Clinical Trial

Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.

Recruiting
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Record status
This record was last updated January 6, 2025 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-23.
Trial Details
NCT Number NCT06756438
Lead Sponsor NAOS Les Laboratoires
Conditions Atopic Dermatitis, Eczema
Enrollment 88 participants
Start Date 2024-09-02
Primary Completion 2025-09-01 (estimated)
Study Completion 2025-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-06