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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06264453

Enrollment

171

Registered

2024-02-20

Start date

2024-03-19

Completion date

2024-09-25

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Hypersensitivity

Keywords

Dentin Sensitivity, Denin Hypersensitivity

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.

Interventions

DRUGKH001

topical applications of KH001

DRUGPlacebo

topical applications of Water for Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Schiff sensitivity score	Baseline and Day 36	Schiff sensitivity score 0-3 by air blast

Secondary

Measure	Time frame	Description
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 a Tactile threshold	Baseline, Day 8, 15, 22, 36 and 43	Tactile threshold by yeaple probe
Change from baseline in Visual Analogue Scale	Baseline, Day 8, 15, 22, 36 and 43	100mm Visual Analogue Scale

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026