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

March 13, 2025 updated by: HysensBio Co., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

171

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

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 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

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 0.2mg/mL
Drug: KH001
topical applications of KH001
Experimental: Group B
KH001 0.4mg/mL
Drug: KH001
topical applications of KH001
Placebo Comparator: Group C
Water for Injection
Drug: Placebo
topical 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 Day 36
Schiff sensitivity score 0-3 by air blast
Baseline and Day 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in a Tactile threshold
Time Frame: Baseline, Day 8, 15, 22, 36 and 43
Tactile threshold by yeaple probe
Baseline, Day 8, 15, 22, 36 and 43
Change from baseline in a Schiff sensitivity score
Time Frame: Baseline, Day 8, 15, 22 and 43
Schiff sensitivity score 0-3 by an evaporative air
Baseline, Day 8, 15, 22 and 43
Change from baseline in Visual Analogue Scale
Time Frame: Baseline, Day 8, 15, 22, 36 and 43
100mm Visual Analogue Scale
Baseline, Day 8, 15, 22, 36 and 43

Collaborators and Investigators

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

Sponsor

HysensBio Co., Ltd

Investigators

  • Principal Investigator: Kyoung-Kyu Choi, D.D.S, Kyung Hee University Dentistry Hospital

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)

March 19, 2024

Primary Completion (Actual)

September 25, 2024

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH-001-D201

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

No

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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