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: Recruiting

Administrative data

• NCT number: NCT06264453
• Other study ID #: KH-001-D201
• Status: Recruiting
• Phase: Phase 2
• Start date: March 19, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: HysensBio Co., Ltd
• Contact: KeumHee Choi
• Phone: +82-2-502-6700
• Email: ckh113[@]hysensbio.com
• Is FDA regulated: No
• 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: 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

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Dental Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HysensBio Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

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	Baseline, Day 8, 15, 22, 36 and 43