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

Assessing effectiveness of combined therapy of antioxidant and topical 5% imiquimod in management of oral leukoplakia – A randomised clinical trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044182

Enrollment

Registered

2022-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue

Interventions

Intervention1: 5% imiquimod and oral antioxidants: 5% imiquimod for topical application will be prescribed along with oral antioxidants. Imiquimod is an anti tumor medication that will help in reversa

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
OLEP StagingTimepoint: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks	—

Secondary

Measure	Time frame
VAS scoreTimepoint: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks	—

Countries

India

Contacts

Public ContactDr Vanshika Jain

Government Dental College and Research Institute

vanshikajain13@gmail.com9818461796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026