Oral leukoplakia is a white patch in the mouth usually developing due to smoking and can convert to oral cancer if not treated. In the following trial, medicinal treatment is being tested which can potentially reverse the changes and stop the development of oral cancer
Phase 3
Completed
- Conditions
- Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
- Registration Number
- CTRI/2022/07/044182
- Lead Sponsor
- Dr Vijayalakshmi KR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients between 18 to 70 years of age
Patients with clinically and histopathologically confirmed oral leukoplakia
Patients willing to be a part of the study and agreeing for the follow-up duration
Exclusion Criteria
Pregnant and lactating patients
Patients undergoing treatment for leukoplakia or any other oral potentially malignant disorder (OPMD) or other systemic pre-cancerous or cancerous conditions
Patient allergic to toluidine blue dye and/ or imiquimod
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OLEP StagingTimepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks
- Secondary Outcome Measures
Name Time Method VAS scoreTimepoint: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks