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Идёт набор NCT06403501

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

Фаза III С лечением Acne Vulgaris

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: Clascoterone, Vehicle cream.
Кому может быть актуально
Состояния в реестре: Acne Vulgaris. Базовые параметры: от 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
Китай
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 Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris

Обзор

The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Вмешательства

  • Препарат Clascoterone
    Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
  • Препарат Vehicle cream
    Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.

Первичные конечные точки

  • Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) [Срок оценки: Week 12]
  • Change From Baseline in Non-inflammatory Lesion (NIL) Counts [Срок оценки: Week 12]
  • Change From Baseline in Inflammatory Lesion (IL) Counts [Срок оценки: Week 12]
Вторичные конечные точки (4)
  • Change From Baseline in Total Lesion Counts [Срок оценки: Week 12]
  • Percent Change From Baseline in Total Lesion Counts [Срок оценки: Week 12]
  • Percent Change From Baseline in Inflammatory Lesion Counts [Срок оценки: Week 12]
  • Percent Change From Baseline in Non-inflammatory Lesion Counts [Срок оценки: Week 12]

Критерии участия

Критерии включения

  • Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
  • Male or female, 12 years of age or older;
  • Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.

Критерии исключения

  • Subject has greater than two (2) facial nodules;
  • Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
  • Subject has used topical and systemic anti-acne medications or therapies;
  • Subject has received hormonal therapy for acne treatment;
  • Subject has used a skincare product with acne removal effect;
  • Subject has other serious underlying diseases such as mental illness or malignant tumors;
  • Subject has any of the clinically significant laboratory test indicators at screening;
  • Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;
  • Subject engaged in drug abuse or excessive alcohol intake;
  • Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;
  • Subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial;
  • Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;
  • Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.

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

Китай · 1 центр
  • Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06403501 · LWY23090C

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗