NCT06264453

A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: HysensBio Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	KH001	topical applications of KH001
DRUG	Placebo	topical applications of Water for Injection

Timeline

• Start date: 2024-03-19
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2024-02-20
• Last updated: 2025-03-14

Locations

1 site across 1 country: South Korea