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

NCT06756438 | Recruiting

• 1 other identifier: RC2024PSaib+PL
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

ATOPIC DERMATITIS; Eczema; Dermocosmetic

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Amr 1: Study product

EXPERIMENTAL

Product 1: Study product, Emollient. Face and body

Other: Study product

Arm 2: Placebo

PLACEBO COMPARATOR

Product 2: Placebo, Emollient. face and body

Other: Placebo

Interventions

Study product OTHER

Anti-itching, anti-replapse and repairing treatment. Emollient.

Amr 1: Study product

Placebo OTHER

Emollient

Arm 2: Placebo

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Specific
• Sex: female and/or male;
• Age: from 3 months up to 12 years old;
• Phototype: I to IV;
• % with atopic skin;
• % 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NAOS Les Laboratoires: lead

Study Sites (1)

EUROFINS

Gdansk, Poméranie, 82-210, Poland

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Wioleta MALINOWWSKA-KAKOL

CONTACT

587320290; wioleta.malinowska-kakol@cpt.eurofinseu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was conducted under a double-blind, randomized, multicenter, before-and-after, parallel-group design. Participants received either the test product or a placebo, while continuing topical corticosteroid treatment in combination or as a relay.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 3, 2025
• Study Start: September 2, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)