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

HysensBio

Status and phase: Completed; Phase 2

Conditions: Dentin Hypersensitivity

Treatments: Drug: Placebo; Drug: KH001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06464939

KH-001-G201

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

KH001 and placebo

Treatment:

Drug: Placebo

Drug: KH001

Group B

Experimental group

Description:

KH001 and placebo

Treatment:

Drug: Placebo

Drug: KH001

Group C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo