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
概览
- 阶段
- 2 期
- 干预措施
- KH001
- 疾病 / 适应症
- Dentin Hypersensitivity
- 发起方
- HysensBio Co., Ltd
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline in Schiff sensitivity score
- 状态
- 已完成
- 最后更新
- 3个月前
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.
研究者
入排标准
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
KH001 and placebo
干预措施: KH001
Group A
KH001 and placebo
干预措施: Placebo
Group B
KH001 and placebo
干预措施: KH001
Group B
KH001 and placebo
干预措施: Placebo
Group C
Placebo
干预措施: Placebo
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)
研究点 (2)
Loading locations...
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