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Идёт набор NCT06716398

A Comparative Study of Cosmetic Product in Subjects With Facial Acne During an Associated-treatment Phase Followed by a Maintenance Phase

Без фазы С лечением Acne

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: Test product, Comparator product.
Кому может быть актуально
Состояния в реестре: Acne. Базовые параметры: 14 лет — 24 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
Бразилия
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

A Randomized Investigator-blinded Comparative Study to Assess the Efficacy of the Cosmetic Care Product RV4133C - Formula JT2559 in Subjects With Facial Acne, During a 3-month-associated-treatment Phase Followed by a 3-month-maintenance Phase

Обзор

In this study, we are interested in the global benefit of the tested product as complementary care to a topical medical treatment during a 3 month-associated treatment phase followed by a 3 month-maintenance phase, compared to a light moisturizing cream, in teenagers and adults with acne. We also want to evaluate the tolerance of the tested product in association and in maintenance of the topical medical treatment.

Вмешательства

  • Другое Test product
    Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.
  • Другое Comparator product
    Twice daily applications, in association of a reference medical treatment during a 3-month-associated-treatment phase, then alone during a 3-month-maintenance phase. The product is applied to the entire face.

Первичные конечные точки

  • Assessment of number of total acne lesions on the face [Срок оценки: Assessment after 24 weeks of use]
Вторичные конечные точки (12)
  • Investigator's global assessment (IGA) [Срок оценки: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Acne lesions counting [Срок оценки: Assessment at baseline and 1 week, 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Acne QoL questionnaire [Срок оценки: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Subject's Global change Assessment (SGA) [Срок оценки: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Post-Inflammatory Hyperpigmentation (PIH) lesions counting [Срок оценки: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Post-Inflammatory Erythema (PIE) lesions counting [Срок оценки: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Subject's Global change Assessment (SGA) of post inflammatory lesions [Срок оценки: Assessment at baseline and after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Acne worsening/ relapse [Срок оценки: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Time to relapse [Срок оценки: Assessment after 4 weeks and 12 weeks of use, without reference medical treatment]
  • Global tolerance assessed by the investigator on a 5-point scale [Срок оценки: Assessment after 4 weeks, 12 weeks, 16 weeks and 24 weeks of use]
  • Compliance of the subjects to the product RV4133C [Срок оценки: Through study completion, 6 months]
  • Cosmetic satisfaction as regards to the use of the test product RV4133C by Cosmetic acceptability questionnaire assessed by the patient [Срок оценки: Assessed after 4 weeks of use]

Критерии участия

Критерии включения

  • Male or Female aged between 14 and 24 years (included)
  • Subject with facial acne with score index severity IGA = 2 or 3, assessed on a scale ranged from 0 to 4.
  • Subject for whom a prescription of 12 weeks of a reference topical medical treatment is required from the day of the inclusion visit, for mild to moderate face acne

Критерии исключения

Criteria related to the disease:

  • Facial skin disease other than acne, skin abnormalities, or dermatological condition on the face liable to interfere with the study assessments
  • Acne conglobata, Acne fulminans, nodulocystic acne or acneiform eruptions, according to investigator's assessment
  • Other type of pigmentation disorder than acne-related PIH liable to interfere with the study assessments according to the investigator

Criteria related to treatments and/or products:

\- Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational products

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
Поддерживающая терапия

Центры проведения

Бразилия · 1 центр
  • UNIFESP — São Paulo

Идентификаторы

NCT: NCT06716398 · RV4133C20230380

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗