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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06464939

Enrollment

120

Registered

2024-06-18

Start date

2024-10-08

Completion date

2025-12-22

Last updated

2026-01-13

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 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.

Interventions

DRUGKH001

Applications of KH001 over a 1 or 2-week period, and application of placebo

DRUGPlacebo

Applications of water for injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in Schiff sensitivity score	Baseline and Week 5	Schiff sensitivity score 0-3 by an evaporative air

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

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