Меню
Идёт набор NCT06930365

Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products In Atopic Dermatitis

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: Anti-itching and repairing treatment. Emollient., Emollient cream.
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis, Eczema. Базовые параметры: от 18 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
Грузия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Clinical-Instrumental Study To Evaluate And Compare The Efficacy And Tolerability Of Two Emollients Products (Investigational Product Versus Placebo) In Atopic Dermatitis

Обзор

Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with erythema, scaly and oozing plaques, and severe pruritus which has an important impact on quality of life and quality of sleep. It is divided into 2 chronic phases : flare-up and remission period. Signs and symptoms of AD are associated with a compromised immune system, a defective skin barrier, a cutaneous dysbiosis and overall inflammatory status. The aim of the study is to evaluate and compare the efficacy and tolerability of two face and body cream products, new emollient versus placebo, in used over the course of 5 weeks as a replacement of usual or any emollient by female and male subjects with atopic dermatitis. This is an interventional, single-center, double-blind, randomized and comparative study.

Вмешательства

  • Другое Anti-itching and repairing treatment. Emollient.
    Anti-itching and repairing treatment. Emollient.
  • Другое Emollient cream
    Emollient cream

Первичные конечные точки

  • SCORAD (SCOring Atopic Dermatisis) [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • EASI (Eczema Area and Severity Index) [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Transepidermal water loss by Vapometer® [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Samplings of the cutaneous microbiota [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10+28 (+/- 48 hours)]
  • Filling of a DLQI questionnaires by participants [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Sleep quality by questionnaire (Pittsburgh Sleep Quality Index) filled in by participants [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]
  • Safety Endpoints [Срок оценки: Day 0, Day 5 to Day 10, Day 5 to Day 10 + 28 (+/- 48hours)]

Критерии участия

Критерии включения

  • Female and/or male participants,
  • Participant aged between 18 years old and more included,
  • All ethnicities
  • Phototype II to IV
  • Participant with all skin types, sensitive or not sensitive,
  • 44 subjects having a rash of eczema (SCORAD between 25 and 50) with at least 1 lesional area requiring topical corticosteroid treatment,
  • 22 healthy subjects (without any dermatological pathology nor disorder),
  • 44 participants having whitened eczema lesions at Dx (between 5 to 10 days) after the topical corticosteroid treatment,
  • Participants having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization,
  • Participant able to comply with the protocol and follow protocol's constraints and specific requirements.

Критерии исключения

  • Participant does not meet the inclusion criteria,
  • Known pregnancy, participant breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study,
  • Participant with dermatological problems in the test areas other than atopic dermatitis,
  • Pharmacological treatments (topic or systemic) other than topical corticosteroids, known to interfere with skin metabolism / physiology. In particular, no antibiotics taken within 4 weeks preceding the inclusion, nor anti- inflammatories taken within 2 weeks before the inclusion
  • Participant being deprived of liberty by judicial or administrative decision, or under guardianship,
  • Participant being linguistically or psychologically incapable of signing informed consent and unable to comply with the protocol requirements,
  • Participant who has a relevant change in his state of health since registered in the LTD "Health" Database (change incompatible with inclusion in the study),
  • Participant currently enrolled in another similar clinical study or in an exclusion period of a study,
  • Participant having a skin recently exposed to sunlight (natural or artificial) and / or having applied a self-tanner on the application areas and /or tanning activator (dietary supplement) within 2 weeks preceding the inclusion.
  • Participant having bathed in a swimming pool within 1 week preceding the inclusion or planning to bath in a swimming pool during the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Грузия · 1 центр
  • Ltd Health — Batumi

Идентификаторы

NCT: NCT06930365 · RC2024/PSaib+/GE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗