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NCT06264453 Clinical Trial

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

Dentin Hypersensitivity Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06264453
Other study ID # KH-001-D201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 11, 2024
Est. completion date August 30, 2024

Study information
Verified date February 2024
Source HysensBio Co., Ltd
Contact KeumHee Choi
Phone +82-2-502-6700
Email ckh113@hysensbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 171
Est. completion date August 30, 2024
Est. primary completion date August 23, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• KH001
3 topical applications of KH001
• Placebo
3 topical applications of Water for Injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
HysensBio Co., Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Schiff sensitivity score Schiff sensitivity score 0-3 by air blast Baseline and Day 36
Secondary Change from baseline in a Schiff sensitivity score Schiff sensitivity score 0-3 by an evaporative air Baseline, Day 8, 15, 22 and 43
Secondary Change from baseline in a Tactile threshold Tactile threshold by yeaple probe Baseline, Day 8, 15, 22, 36 and 43
Secondary Change from baseline in Visual Analogue Scale 100mm Visual Analogue Scale by ice cold water Baseline, Day 8, 15, 22, 36 and 43
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Completed NCT03965039 - A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity N/A
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