COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-10-08
Study Completion:2025-12-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06464939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is at least 18 years old by the time of the screening visit
  2. * Is in good general health as determined by the investigator
  3. * Has at least 2 non-adjacent teeth and is diagnosed with hypersensitive
  1. * Is allergic to the active drug substance or other excipients used in the investigational product
  2. * Has any history of alcohol or drug abuse
  3. * Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
  4. * Is jedged by the investigator as ineligible for participation for other reasons

Contacts and Locations

Principal Investigator

Hatice Hasturk
PRINCIPAL_INVESTIGATOR
ADA Forsyth

Study Locations (Sites)

ADA Forsyth
Cambridge, Massachusetts, 02142
United States
Forsyth Institute
Cambridge, Massachusetts, 02142
United States

Collaborators and Investigators

Sponsor: HysensBio Co., Ltd

  • Hatice Hasturk, PRINCIPAL_INVESTIGATOR, ADA Forsyth

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-08
Study Completion Date2025-12-22

Study Record Updates

Study Start Date2024-10-08
Study Completion Date2025-12-22

Terms related to this study

Keywords Provided by Researchers

  • Dentin Sensitivity
  • Denin Hypersensitivity

Additional Relevant MeSH Terms

  • Dentin Hypersensitivity