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

January 11, 2026 updated by: HysensBio Co., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • Forsyth Institute
      • Cambridge, Massachusetts, United States, 02142
        • ADA Forsyth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
KH001 and placebo
Drug: KH001
Applications of KH001 over a 1 or 2-week period, and application of placebo
Drug: Placebo
Applications of water for injection
Experimental: Group B
KH001 and placebo
Drug: KH001
Applications of KH001 over a 1 or 2-week period, and application of placebo
Drug: Placebo
Applications of water for injection
Placebo Comparator: Group C
Placebo
Drug: Placebo
Applications of water for injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HysensBio Co., Ltd

Collaborators

The Forsyth Institute

Investigators

  • Principal Investigator: Hatice Hasturk, ADA Forsyth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Actual)

December 22, 2025

Study Completion (Actual)

December 22, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH-001-G201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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