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

HysensBio Co., Ltd171 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

171

Conditions

Dentin Hypersensitivity

Interventions

KH001DRUG

topical applications of KH001

PlaceboDRUG

topical applications of Water for Injection

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyung Hee University Dental Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline in Schiff sensitivity score

Schiff sensitivity score 0-3 by air blast

Time frame: Baseline and Day 36

Secondary Outcomes

Change from baseline in a Schiff sensitivity score

Schiff sensitivity score 0-3 by an evaporative air

Time frame: Baseline, Day 8, 15, 22 and 43

Change from baseline in a Tactile threshold

Tactile threshold by yeaple probe

Time frame: Baseline, Day 8, 15, 22, 36 and 43

Change from baseline in Visual Analogue Scale

100mm Visual Analogue Scale

Time frame: Baseline, Day 8, 15, 22, 36 and 43

Data from ClinicalTrials.gov

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