A Study to Evaluate the Efficacy and Safety of KH001 in P... | NCT06264453

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

NCT06264453

Sponsor

HysensBio Co., Ltd

Status

Completed

Last Update Posted

Mar 14, 2025Actual

Enrollment

171Actual

Phase

Phase 2

Conditions

Dentin Hypersensitivity

Interventions

KH001
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2024Actual

Primary Completion Date

Sep 25, 2024Actual

Completion Date

Sep 25, 2024Actual

First Submitted Date

Feb 9, 2024

First Submission Date that Met QC Criteria

Feb 9, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2025

Last Update Posted Date

Mar 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

171Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	KH001 0.2mg/mL	Drug: KH001
Group B	Experimental	KH001 0.4mg/mL	Drug: KH001
Group C	Placebo Comparator	Water for Injection	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KH001	Drug	topical applications of KH001	Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in a Schiff sensitivity score	Schiff sensitivity score 0-3 by an evaporative air	Baseline, Day 8, 15, 22 and 43
Change from baseline in a Tactile threshold	Tactile threshold by yeaple probe

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyoung-Kyu Choi, D.D.S	Kyung Hee University Dentistry Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyung Hee University Dental Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003807	Dentin Sensitivity

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided