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

Dentin Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464939
• Other study ID #: KH-001-G201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 19, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: HysensBio Co., Ltd
• Contact: Sunhee Park
• Phone: +82-2-502-6700
• Email: sunheepark[@]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 subjects with dentin hypersensitivity.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dentin Hypersensitivity
• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• KH001
Applications of KH001 over a 1 or 2-week period, and application of placebo
• Placebo
Applications of water for injection

Locations

Country	Name	City	State
United States	ADA Forsyth	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
HysensBio Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Schiff sensitivity score	Schiff sensitivity score 0-3 by an evaporative air	Baseline and Week 5
Secondary	Change from baseline in a Schiff sensitivity score	Schiff sensitivity score 0-3 by an evaporative air	Baseline, Up to 8 Weeks
Secondary	Change from baseline in a Tactile threshold	Tactile threshold by yeaple probe	Baseline, Up to 8 Weeks
Secondary	Change from baseline in Visual Analogue Scale	Visual Analogue Scale by an evaporative air	Baseline, Up to 8 Weeks