NCT06756438

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

Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study Vs Placebo -- Use Test Under Dermatological Control -

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: NAOS Les Laboratoires · Industry
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Eczema

Interventions

Type	Name	Description
OTHER	Study product	Anti-itching, anti-replapse and repairing treatment. Emollient.
OTHER	Placebo	Emollient

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-01-03
• Last updated: 2025-01-06

Locations

1 site across 1 country: Poland