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

Last updated: January 3, 2025
Sponsor: NAOS Les Laboratoires
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Allergy

Rash

Treatment

Study product

Placebo

Clinical Study ID

NCT06756438
RC2024PSaib+PL
  • Ages 3-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 6months 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 dermatologistprescribed 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 topicalcorticosteroids from D-X up to D0 and clinical signs of atopic dermatitis areresolved, to be defined on D0 visit (in case of insufficient healing of inflammatorylesions, the subject continues medical treatment as recommended by theinvestigator).

General

  • Healthy subject;

  • Child whose at least one parent/legal guardian has given freely and expresslyher/his informed consent;

  • Child whose at least one parent/legal guardian is willing to adhere to the protocoland study procedures;

  • Polish citizenship.

Exclusion

Exclusion Criteria:

  • Cutaneous pathology on the study zone other than atopic dermatitis;

  • Use of topical or systemic treatment during the previous weeks liable to interferewith the assessment of the efficacy of the study products, including anti-histaminictreatment (except prescribed dermocorticoids on D-X and in case of flare-up duringthe study course);

  • Subject having undergone a surgery under general anesthesia within the previousmonth;

  • Excessive exposure to sunlight or UV-rays within the previous month;

  • Subject enrolled in another clinical trial during the study period (concerns thestudied zones);

  • Subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Study product
Phase:
Study Start date:
September 02, 2024
Estimated Completion Date:
September 01, 2025

Connect with a study center

  • EUROFINS

    Gdansk, Poméranie 82-210
    Poland

    Active - Recruiting

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