A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 176
- 试验地点
- 3
- 主要终点
- Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
研究概览
简要总结
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 30 - 60 years of age
- •Moderate to severe vertical glabellar lines at maximum frown at baseline
排除标准
- •Silicone injections into the upper face
- •Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
- •Any planned facial cosmetic surgery during the study period
- •A history of ablative skin resurfacing of the area to be treated during the study.
研究组 & 干预措施
Dysport RU 20 U
干预措施: Botulinum toxin type A (Biological)
Dysport RU 50 U
干预措施: Botulinum toxin type A (Biological)
Dysport RU 75 U
干预措施: Botulinum toxin type A (Biological)
Dysport (Azzalure) 50 U
干预措施: Botulinum toxin type A (Biological)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
时间窗: Day 29
Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.
次要结局
- Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.(Days 8, 15, 57, 85 and 113)
- Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.(Days 8, 15, 57, 85 and 113)
- Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.(Days 8, 15, 57, 85 and 113)
- Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders(Day 113)
- Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.(Day 29)
- Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)(Days 8, 15, 29, 57, 85 and 113)
- Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)(Day 29)