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Идёт набор NCT06205797

To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III)

Фаза III С лечением Glabellar Lines

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: HU-045, Xeomin®.
Кому может быть актуально
Состояния в реестре: Glabellar Lines. Базовые параметры: 19 лет — 65 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
South Korea
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, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HU-045 Compared to Xeomin® in Adult Patients With Moderate or Severe Glabellar Lines

Обзор

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines

Вмешательства

  • Препарат HU-045
    HU-045 is a medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use. White powder Other Names: IncobotulinumtoxinA
  • Препарат Xeomin®
    Xeomin® is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It should be reconstituted with sterile, preservative-free 0.9% saline before use. Other Names: IncobotulinumtoxinA

Первичные конечные точки

  • Percentage of participants whose glabellar lines at maximal frown are improved [Срок оценки: Week4]
Вторичные конечные точки (4)
  • Percentage of participants whose glabellar lines at maximal frown are improved [Срок оценки: Week8, Week12, Week16]
  • Percentage of participants whose glabellar lines at resting are improved [Срок оценки: Week4, Week8, Week12, Week16]
  • Subject's satisfaction rate after injection [Срок оценки: Week4, Week8, Week12, Week16]
  • Percentage of subjects who assessed their Glabellar Lines are improved ≥ +2 grade [Срок оценки: Week4, Week8, Week12, Week16]

Критерии участия

Критерии включения

  • 19 Years to 65 Years(Adult, Older Adult)
  • 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
  • Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.

Критерии исключения

  • Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
  • History of bleeding disorder
  • Infection, dermatological condition or scar at the treatment injection sites
  • Subject who has marked facial asymmetry
  • History of facial nerve palsy or eyebrow/eyelid ptosis
  • History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
  • History of malignant tumor within 5 years (except for basal cell carcinoma
  • Any disease and condition that, in the view of the investigator, would interfere with study participation
  • History of alcohol or drug addiction
  • Subject who has been treated with any botulinum toxin drug within 6 months
  • Persons who have received the following drugs with systemic muscle relaxant action within 4 weeks of screening
  • Subjects taking more than 1,000 IU/day of anticoagulants, antiplatelet agents, NSAIDs, or vitamin E within 7 days prior to administration of the investigational drug (excluding low-dose aspirin)
  • A person who has received a retinoid series of medications during the following period as of the time of screening
  • Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
  • History of Anaphylaxis or severe combined allergy disease
  • Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
  • Pregnant and lactating women F- ertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
  • Participant who has been treated with any investigational drug within 30 days from screening
  • Subject who are not eligible for this study based on investigator's judgement.

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

South Korea · 1 центр
  • Kangbuk Samsung Hospital — Seoul

Идентификаторы

NCT: NCT06205797 · HU-045_P3

Первоисточники (государственные реестры)

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