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临床试验/NCT04247074
NCT04247074已完成3 期

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

Galderma R&D12 个研究点 分布在 2 个国家目标入组 413 人开始时间: 2020年2月10日最近更新:
适应症
干预措施

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

Experimental

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

Experimental

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

Placebo Comparator

A buffered solution; Mode of administration:

intramuscular injection

干预措施: Placebo (Biological)

QM1114-DP in the LCL + GL

Experimental

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

Experimental

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

Experimental

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)

研究者

发起方
Galderma R&D
申办方类型
Industry
责任方
Sponsor

研究点 (12)

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