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Идёт набор NCT06756438

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

Без фазы С лечением Atopic Dermatitis Eczema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Study product, Placebo.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis, Eczema. Базовые параметры: 3 мес. — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy Evaluation and Cutaneous Acceptibility of a Dermocosmetic Product on Subjects Suffering of Atopic Dermatisis - Study Vs Placebo -- Use Test Under Dermatological Control -

Обзор

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.

Вмешательства

  • Другое Study product
    Anti-itching, anti-replapse and repairing treatment. Emollient.
  • Другое Placebo
    Emollient

Первичные конечные точки

  • SCOring Atopic Dermatisis (SCORAD) [Срок оценки: 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) [Срок оценки: Before (Day -X) and after the products use (Day 0, Month 2, Month 4 and Month 6)]
  • CUTANEOUS ACEPTABILITY [Срок оценки: 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 [Срок оценки: Before (Day-X) and after the products use (Day 0, Month 2, Month 4 and Month 6)]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • EUROFINS — Gdansk

Идентификаторы

NCT: NCT06756438 · RC2024PSaib+PL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗