Imiquimod cream for oral dysplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with biopsy-proven oral epithelial dysplasia who are ineligible for or decline surgical or laser removal will apply topical 5% imiquimod cream to their oral lesions. The study combines Phase 1 safety and feasibility objectives with Phase 2 measures of lesion size and tissue change, and includes two follow-up biopsies after treatment to document histologic response. Investigators will monitor for local side effects and practical issues with intraoral application to refine a safe, usable regimen. The goal is to determine whether topical therapy can be a non-surgical option for managing dysplastic oral lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• OralCare PreCancer and Pain Clinic
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Anette Vistoso Monreal
• Email: avistoso@ostrow.usc.edu
• Phone: (213) 821-0148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.