NCT06464939

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: HysensBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	KH001	Applications of KH001 over a 1 or 2-week period, and application of placebo
DRUG	Placebo	Applications of water for injection

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-12-22
• Completion: 2025-12-22
• First posted: 2024-06-18
• Last updated: 2026-01-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study