Topical Imiquimod Treatment of Oral Dysplasia

Recruiting now · Phase 1/Phase 2

Conditions studied: Oral Dysplasia, Leukoplakia Oral, Leukoplakia

In brief

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.

Key facts

Study ID

NCT07210775

Run by

University of Southern California

People needed

20

Starts

2025-10-01

Expected to finish

2027-10-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OralCare PreCancer and Pain Clinic — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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