Phase 2 Study of KH001 in Long-term Relief from Dentin Hypersensitivity

Phase 2

Recruiting

• Conditions: Dentin Hypersensitivity
• Interventions: Drug: KH001; Drug: Placebo

• Registration Number: NCT06464939
• Lead Sponsor: HysensBio Co., Ltd

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Status Verified: 2024-10
• Study Start: 2024-10-08
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-02-28
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

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
• Is jedged by the investigator as ineligible for participation for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Placebo	KH001 and placebo
Group B	KH001	KH001 and placebo
Group A	KH001	KH001 and placebo
Group B	Placebo	KH001 and placebo
Group C	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in Schiff sensitivity score	Baseline and Week 5	Schiff sensitivity score 0-3 by an evaporative air

Secondary Outcome Measures

Name	Time	Method
Change from baseline in a Schiff sensitivity score	Baseline, Up to 8 Weeks	Schiff sensitivity score 0-3 by an evaporative air
Change from baseline in a Tactile threshold	Baseline, Up to 8 Weeks	Tactile threshold by yeaple probe
Change from baseline in Visual Analogue Scale	Baseline, Up to 8 Weeks	Visual Analogue Scale by an evaporative air

Trial Locations

Locations (2)

Forsyth Institute; 🇺🇸 Cambridge, Massachusetts, United States

ADA Forsyth; 🇺🇸 Cambridge, Massachusetts, United States