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

NAOS Les Laboratoires

Status: Enrolling

Conditions: Atopic Dermatitis; Eczema

Treatments: Other: Placebo; Other: Study product

Study type: Interventional

Funder types: Industry

Identifiers

NCT06756438

RC2024PSaib+PL

Details and patient eligibility

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Amr 1: Study product

Experimental group

Description:

Product 1: Study product, Emollient. Face and body

Treatment:

Other: Study product

Arm 2: Placebo

Placebo Comparator group

Description:

Product 2: Placebo, Emollient. face and body

Treatment:

Other: Placebo