A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
A Phase 1 Study to Evaluate the Safety and Efficacy of Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL.
AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States.
Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：ABBVIE CALL CENTER
- 电话号码：844-663-3742
- 邮箱：abbvieclinicaltrials@abbvie.com
学习地点
-
-
Arizona
-
Glendale、Arizona、美国、85308
- 招聘中
- Advanced Research Associates - Glendale /ID# 283833
-
-
California
-
Newport Beach、California、美国、92663
- 招聘中
- Eye Research Foundation /ID# 283835
-
Vista、California、美国、92083
- 招聘中
- Pacific Clinical Innovations /ID# 283812
-
-
Louisiana
-
New Orleans、Louisiana、美国、70130
- 招聘中
- Etre, Cosmetic Dermatology And Laser Center /ID# 283831
-
-
Massachusetts
-
Chestnut Hill、Massachusetts、美国、02467
- 招聘中
- Skincare Physicians /ID# 283851
-
-
North Carolina
-
Wilmington、North Carolina、美国、28403
- 招聘中
- Wilmington Dermatology Center /ID# 283853
-
-
Tennessee
-
Nashville、Tennessee、美国、37215
- 招聘中
- Tennessee Clinical Research Center /ID# 283894
-
-
Texas
-
Pflugerville、Texas、美国、78660
- 招聘中
- Austin Institute for Clinical Research - Pflugerville /ID# 283817
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters
- Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator.
Exclusion Criteria:
- Severe glabellar lines at rest as assessed by the investigator using the FWS
- Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening
- History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.
|
Injection
Injection
|
|
实验性的：Cohort 2 - AGN-151586 and BOTOX
Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.
|
Injection
Injection
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
大体时间：Up to Approximately Day 141
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The investigator assesses the relationship of each event to the use of study drug and the study drug injection procedure.
|
Up to Approximately Day 141
|
合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.