Actively Recruiting
Evaluation of a Dermocosmetic Product Versus Placebo for Atopic Dermatitis in Children A Randomized, Double-Blind Study Under Dermatological Supervision
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 condition mainly affecting children, marked by itching and flare-ups. This study evaluates the effectiveness of a dermocosmetic product compared to a placebo in managing atopic skin, focusing on reducing the number, timing, and severity of eczema recurrences. The study also looks at symptoms including dryness, itching, and sleep quality, while monitoring skin acceptability of the treatments. Participants are randomly assigned to receive either the study product, which is an anti-itching, anti-relapse, and repairing emollient treatment, or a placebo emollient. These products are applied under dermatological supervision, alongside the participants' ongoing topical corticosteroid treatments. The study is conducted as a multicenter, double-blind clinical trial. During the study, eczema severity is measured using the SCORAD score at baseline (Day -X), Day 0, and at 2, 4, and 6 months after starting treatment. Dermatologists examine participants' skin on these same days to assess skin acceptability and monitor symptoms like dryness, itching, and sleep disturbances. Quality of life, sleep quality, and safety are also evaluated throughout the trial, which includes children aged 3 months to 12 years.
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
EUROFINS
Gdansk, Poméranie, Poland, 82-210
Actively Recruiting
Research Team
W
Wioleta MALINOWWSKA-KAKOL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here