NCT06464939已完成2 期
A Randomized, Double-blinded, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of Three Topical Applications of KH001 in Providing Long-term Relief From Dentin Hypersensitivity
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline in Schiff sensitivity score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.
详细描述
The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years old by the time of the screening visit
- •Is in good general health as determined by the investigator
- •Has at least 2 non-adjacent teeth and is diagnosed with hypersensitive
排除标准
- •Is allergic to the active drug substance or other excipients used in the investigational product
- •Has any history of alcohol or drug abuse
- •Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
- •Is jedged by the investigator as ineligible for participation for other reasons
研究组 & 干预措施
Group A
Experimental
KH001 and placebo
干预措施: KH001 (Drug)
Group A
Experimental
KH001 and placebo
干预措施: Placebo (Drug)
Group B
Experimental
KH001 and placebo
干预措施: KH001 (Drug)
Group B
Experimental
KH001 and placebo
干预措施: Placebo (Drug)
Group C
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Schiff sensitivity score
时间窗: Baseline and Week 5
Schiff sensitivity score 0-3 by an evaporative air
次要结局
- Change from baseline in a Schiff sensitivity score(Baseline, Up to 8 Weeks)
- Change from baseline in a Tactile threshold(Baseline, Up to 8 Weeks)
- Change from baseline in Visual Analogue Scale(Baseline, Up to 8 Weeks)
研究者
研究点 (2)
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