jRCT2031230499进行中（未招募）不适用
A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatmentof Japanese Subjects with Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AbbVie GK
- 入组人数
- 24
- 主要终点
- Facial Wrinkle Scale with Asian (FWS-A) Photonumeric Guide
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 65age old not（—）
- 性别
- All
入选标准
- •Participants must be in good health as per investigator'sjudgment based on medical history, physical examination,neurological assessment, clinical laboratory evaluations,ECG results, and vital sign measurements.
- •Participants must have moderate or severe GL at maximum frown as assessed by the investigator using theFWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.
排除标准
- •Participants must not have uncontrolled systemic disease.
- •History of known immunization to any botulinum neurotoxin serotype
- •Tattoos, jewelry, or clothing which obscure the glabellararea and cannot be removed.
- •Anticipated need for surgery or overnight hospitalizationduring the study.
- •History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
- •History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
- •Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- •Female subject who is pregnant or breastfeeding, and isconsidering becoming pregnant or donating eggs during thestudy or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
- •Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- •Anticipated need for treatment with botulinum neurotoxinof any serotype for any reason during the study (other thanstudy drug).
结局指标
主要结局
Facial Wrinkle Scale with Asian (FWS-A) Photonumeric Guide
时间窗: at anytimepoint through Day 7
Percentage of participants with a >= 2-grade improvement from baseline on the Facial Wrinkle Scale with Asian (FWS-A) Photonumeric Guide according to investigator assessment of Glabellar Lines (GL) severity at maximum frown
次要结局
- Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
- Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
- Percentage of participants with a None or Mild on the FWS-A according to investigator assessment of GL severity at maximum frown over time
研究者
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