A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- IGA-FWS
研究概览
简要总结
This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be outpatient, male or female subjects, in good general health, 18 years of age or older
- •Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS
- •Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS
排除标准
- •Previous treatment with botulinum toxin type A in the face, or treatment with >200 U of any botulinum toxin anywhere else in the body, in the past 6 months prior to screening
- •Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception
- •Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product
研究组 & 干预措施
Active Treatment (DAXXIFY)
All subjects will receive DAXXIFY for injection as IM injections.
干预措施: DAXXIFY (Drug)
结局指标
主要结局
IGA-FWS
时间窗: Week 4
• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in GL severity at maximum contraction (maximum frown) at Week 4 as assessed by the IGA-FWS
IGA-FHWS
时间窗: Week 4
• The proportion of subjects achieving a score of 0 (none) or 1 (mild) in FHL severity at maximum contraction (maximum eyebrow elevation) at Week 4 as assessed by the IGA-FHWS
次要结局
未报告次要终点