Actively Recruiting
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
Led by NAOS Les Laboratoires · Updated on 2025-01-06
88
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male children
- Age from 3 months up to 12 years old
- Skin phototype I to IV
- Atopic skin
- Sensitive skin
- At least 3 eczema flare-ups in the last 6 months including current flare-up
- Currently experiencing an eczema flare-up treated with topical corticosteroids prescribed by a dermatologist
- SCORAD score between 15 and 40 at baseline visit
- No longer requiring medical treatment after corticosteroid use and resolved clinical signs by Day 0
- Generally healthy
- Parent or legal guardian has given informed consent
- Parent or legal guardian willing to follow study procedures
- Polish citizenship
You will not qualify if you...
- Skin disease in the study area other than atopic dermatitis
- Use of treatments in the past weeks that may affect study results except prescribed corticosteroids
- Surgery under general anesthesia within the previous month
- Excessive sunlight or UV exposure within the previous month
- Participation in another clinical trial affecting the study zones
- Presence of oozing eczema lesions or signs of infection such as pus on eczema
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
EUROFINS
Gdansk, Poméranie, Poland, 82-210
Actively Recruiting
Research Team
W
Wioleta MALINOWWSKA-KAKOL
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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