跳至主要内容
临床试验/NCT02607670
NCT02607670Unknown2 期

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of TAT4 Gel for the Reduction of Nasolabial Folds

Topokine Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
111
试验地点
1
主要终点
Nasolabial Fold Severity Scale (Clinician-Reported)

研究概览

简要总结

This is a Phase 2, randomized, double-blind, placebo-controlled study of TAT4 Gel for the reduction of moderate to severe nasolabial folds.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate to severe, bilateral nasolabial folds
  • Must understand and provide informed consent

排除标准

  • Pregnant or lactating women
  • History of skin hypersensitivity of atopic dermatitis
  • Any illness of disease that, in the investigator's opinion, would make trial participation inadvisable

研究组 & 干预措施

TAT4 Gel

Experimental

The participant will apply TAT4 Gel to the nasolabial fold area once daily.

干预措施: TAT4 Gel (Drug)

Placebo

Placebo Comparator

The participant will apply Placebo Gel to the nasolabial fold area once daily.

干预措施: Matching placebo (Drug)

结局指标

主要结局

Nasolabial Fold Severity Scale (Clinician-Reported)

时间窗: Day 91

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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