Topical Imiquimod Treatment of Oral Dysplasia
Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
University of Southern California
20 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to determine the effectiveness of imiquimod in treating oral dysplasia in adult patients. Imiquimod 5% cream could be a safe and practical treatment for oral epithelial dysplasia (a precancerous change in the mouth). The main questions it aims to answer are: 1. Does imiquimod help to make the lesions smaller and make the abnormal cell changes less severe? 2. How can we make this treatment safer and more feasible? Participants will apply topical imiquimod cream to treat the oral dysplasia and receive two follow-up biopsies after the treatment.
Eligibility
Inclusion Criteria4
- The patient has a biopsy-proven diagnosis of oral epithelial dysplasia.
- The patient is ineligible for or unwilling to undergo surgical or laser therapy.
- The patient is over 18 years old.
- The patient agrees to join the study and completes the informed consent process.
Exclusion Criteria4
- The patient has OL, and excisional surgical removal is indicated.
- The patient is immunocompromised.
- The patient is under 18 years old.
- The patient refused to join the study or did not complete the informed consent process.
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Interventions
Participants will be prescribed imiquimod 5% cream, with instructions to apply the cream with soft tray or gauze daily for one hour, five days a week (Monday to Friday). 6 week as one course and additional course may be added based on participant's conditions and consent. 2 follow up biopsies are scheduled 6 months and 12 months after the start of the treatment course.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07210775