A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity
- Registration Number
- NCT06264453
- Lead Sponsor
- HysensBio Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C Placebo Water for Injection Group A KH001 KH001 0.2mg/mL Group B KH001 KH001 0.4mg/mL
- Primary Outcome Measures
Name Time Method Change from baseline in Schiff sensitivity score Baseline and Day 36 Schiff sensitivity score 0-3 by air blast
- Secondary Outcome Measures
Name Time Method Change from baseline in a Schiff sensitivity score Baseline, Day 8, 15, 22 and 43 Schiff sensitivity score 0-3 by an evaporative air
Change from baseline in Visual Analogue Scale Baseline, Day 8, 15, 22, 36 and 43 100mm Visual Analogue Scale
Change from baseline in a Tactile threshold Baseline, Day 8, 15, 22, 36 and 43 Tactile threshold by yeaple probe
Trial Locations
- Locations (1)
Kyung Hee University Dental Hospital
🇰🇷Seoul, Korea, Republic of