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 -

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 Overview

• Status: Recruiting
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Other: Study product; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wioleta MALINOWWSKA-KAKOL; Phone Number: 587320290; Email: wioleta.malinowska-kakol@cpt.eurofinseu.com

Study Locations

• Poland
  • Poméranie
    • Gdansk, Poméranie, Poland, 82-210
      • Recruiting
      • Eurofins
      • Contact: Wioleta MALINOWSKA; Phone Number: +48 58 732 02 90; Email: wioleta.malinowska-kakol@cpt.eurofinseu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Specific

• 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).

General

• Healthy subject;
• Child whose at least one parent/legal guardian has given freely and expressly her/his informed consent;
• Child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures;
• Polish citizenship.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amr 1: Study product; Product 1: Study product, Emollient. Face and body	Other: Study product; Anti-itching, anti-replapse and repairing treatment. Emollient.
Placebo Comparator: Arm 2: Placebo; Product 2: Placebo, Emollient. face and body	Other: Placebo; Emollient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCOring Atopic Dermatisis (SCORAD)	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.	Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
SCORING ATOPIC DERMATITIS BY SUBJECT'S PARENT/LEGAL GUARDIAN (PO-SCORAD)	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.	Before (Day -X) and after the products use (Day 0, Month 2, Month 4 and Month 6)
CUTANEOUS ACEPTABILITY	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.	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.
Evaluation of "xerosis", "pruritus" and "insomnia" evolution based on SCORAD	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.	Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)

Collaborators and Investigators

• Sponsor: NAOS Les Laboratoires

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Eczema; ATOPIC DERMATITIS; Dermocosmetic
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: RC2024PSaib+PL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No