Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study Vs Placebo -- Use Test Under Dermatological Control -
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NAOS Les Laboratoires
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- SCOring Atopic Dermatisis (SCORAD)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 3 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sex: female and/or male;
- •Age: from 3 months up to 12 years old;
- •Phototype: I to IV;
- •100% with atopic skin;
- •100% with sensitive skin;
- •Subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6 months before start of the study, including the crisis observed on D-X.
- •Subject presenting on the visit D-X a flare-up of eczema for which the dermatologist prescribed treatment with topical corticosteroids treatment;
- •Subjects with SCORAD between 15 and 40 on D-X;
- •Subject who do not require medical treatment anymore after using prescribed topical corticosteroids from D-X up to D0 and clinical signs of atopic dermatitis are resolved, to be defined on D0 visit (in case of insufficient healing of inflammatory lesions, the subject continues medical treatment as recommended by the investigator).
- •Healthy subject;
Exclusion Criteria
- •Cutaneous pathology on the study zone other than atopic dermatitis;
- •Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on D-X and in case of flare-up during the study course);
- •Subject having undergone a surgery under general anesthesia within the previous month;
- •Excessive exposure to sunlight or UV-rays within the previous month;
- •Subject enrolled in another clinical trial during the study period (concerns the studied zones);
- •Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).
Outcomes
Primary Outcomes
SCOring Atopic Dermatisis (SCORAD)
Time Frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
SCORING ATOPIC DERMATITIS BY SUBJECT'S PARENT/LEGAL GUARDIAN (PO-SCORAD)
Time Frame: Before (Day -X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The PO-SCORAD ( Patient-Oriented SCOring Atopid Dermatisis) scale ranges from a minimum score of 0 to a maximum score of 75, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
CUTANEOUS ACEPTABILITY
Time Frame: On Day 0, Month 2, Month 4 and Month 6 of the product use, the body and face of the subject is examined by the dermatologist in charge of the study.
The product's capacity to maintain human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist in charge of the study to assess each following parameters : erythema, edema, dryness, desquamation, roughness, fonctional and physical signs.
Evaluation of "xerosis", "pruritus" and "insomnia" evolution based on SCORAD
Time Frame: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
The SCORAD (Scoring Atopic Dermatitis) scale ranges from a minimum score of 0 to a maximum score of 103, where higher scores indicate a worse outcome, reflecting more severe atopic dermatitis.
Secondary Outcomes
No secondary outcomes reported