A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Exploratory Study to Investigate NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Change from Baseline to Week 4 in Pore Volume in the Cheek Area
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.
详细描述
Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cheek pore size assessed as "large" by the investigator
- •Oily skin on the forehead
排除标准
- •Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months
- •Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months
- •Treatment with any dermal filler in the face within the last 12 months
- •Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate)
- •Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype
研究组 & 干预措施
NT 201
Single NT 201 injection treatment.
干预措施: NT 201 (Drug)
Placebo
Single placebo injection treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
时间窗: Baseline (Day 1), Week 4
Antera 3D will be used as an assessment tool.
Change from Baseline to Week 4 in Sebum Level in the Forehead Area
时间窗: Baseline (Day 1), Week 4
Sebumeter will be used as an assessment tool.
次要结局
未报告次要终点