Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

Официальное название

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection (Eveotox) Compared With a Single Treatment of Botox and Placebo,and Repeated Treatment of Eveotox in Moderate to Severe Glabellar Lines

Обзор

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.

Вмешательства

• Биопрепарат Rcombinant botulinum toxin type A for injection（Eveotox)
  Rcombinant botulinum toxin type A for injection（Eveotox)
• Биопрепарат OnabotulinumtoxinA (Botox)
  OnabotulinumtoxinA (Botox)
• Биопрепарат Placebo
  Placebo

Первичные конечные точки

• Primary Outcome Measure [Срок оценки: Within 4 weeks]

Вторичные конечные точки (1)

• Secondary Outcome Measure [Срок оценки: Within 52 weeks]

Критерии участия

Критерии включения

• Male or female subjects who are between 18 to 65 years of age
• Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
• Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
• Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Критерии исключения

• Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
• Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
• Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
• Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• Peking Union Medical College Hospital — Пекин
• Peking University First Hospital — Пекин
• Peking University Third Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Jinan University — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The First Hospital of Hebei Medical University — Shijiazhuang
• The Third Xiangya Hospital of Central South University — Чанша
• … и ещё 7 центров

Идентификаторы

NCT: NCT06937944 · JHM03-CT301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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