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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-12-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

KH001 and placebo

Group Type EXPERIMENTAL

KH001

Intervention Type DRUG

Applications of KH001 over a 1 or 2-week period, and application of placebo

Placebo

Intervention Type DRUG

Applications of water for injection

Group B

KH001 and placebo

Group Type EXPERIMENTAL

KH001

Intervention Type DRUG

Applications of KH001 over a 1 or 2-week period, and application of placebo

Placebo

Intervention Type DRUG

Applications of water for injection

Group C

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Applications of water for injection

Interventions

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KH001

Applications of KH001 over a 1 or 2-week period, and application of placebo

Intervention Type DRUG

Placebo

Applications of water for injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No