A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 413
- 试验地点
- 12
- 主要终点
- Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years of age or older.
- •Moderate to severe LCL at maximum smile as assessed by the Investigator.
- •Moderate to severe LCL at maximum smile as assessed by the subject.
- •Moderate to severe GL at maximum frown as assessed by the Investigator.
- •Moderate to severe GL at maximum frown as assessed by the subject
排除标准
- •Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- •Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- •Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).
研究组 & 干预措施
QM1114-DP in the LCL + Placebo in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
干预措施: Placebo (Biological)
Placebo in the LCL + QM1114-DP in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection
干预措施: Placebo (Biological)
Placebo in the LCL and GL
A buffered solution; Mode of administration:
intramuscular injection
干预措施: Placebo (Biological)
QM1114-DP in the LCL + GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
干预措施: botulinum toxin neuromodulator (Biological)
Placebo in the LCL + QM1114-DP in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection
干预措施: botulinum toxin neuromodulator (Biological)
QM1114-DP in the LCL + Placebo in the GL
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
干预措施: botulinum toxin neuromodulator (Biological)
结局指标
主要结局
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
时间窗: Month 1
Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
时间窗: Month 1
Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).
次要结局
- Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown(Month 1)
- Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.(Month 1)
