NCT06264453
Completed
Phase 2
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-designed, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
Overview
- Phase
- Phase 2
- Intervention
- KH001
- Conditions
- Dentin Hypersensitivity
- Sponsor
- HysensBio Co., Ltd
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Change from baseline in Schiff sensitivity score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.
Detailed Description
This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is at least 19 years old by the time of the screening visit
- •Be in good general health as determined by the investigator
- •Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive
Exclusion Criteria
- •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
- •Has active dental caries or history of dental caries
Arms & Interventions
Group A
KH001 0.2mg/mL
Intervention: KH001
Group B
KH001 0.4mg/mL
Intervention: KH001
Group C
Water for Injection
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in Schiff sensitivity score
Time Frame: Baseline and Day 36
Schiff sensitivity score 0-3 by air blast
Secondary Outcomes
- Change from baseline in a Schiff sensitivity score(Baseline, Day 8, 15, 22 and 43)
- Change from baseline in Visual Analogue Scale(Baseline, Day 8, 15, 22, 36 and 43)
- Change from baseline in a Tactile threshold(Baseline, Day 8, 15, 22, 36 and 43)
Study Sites (1)
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