Imiquimod cream for oral dysplasia
Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
This trial will test whether applying 5% imiquimod cream inside the mouth can shrink precancerous oral dysplasia and reduce abnormal cells in adults who cannot or do not want surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07210775 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with biopsy-proven oral epithelial dysplasia who are ineligible for or decline excisional/laser therapy and can complete informed consent are ideal candidates.
Not a fit: Patients whose lesions clearly require excisional surgery, immunocompromised individuals, and those under 18 are unlikely to benefit from this topical approach.
Why it matters
Potential benefit: If successful, this could provide a non-surgical way to shrink lesions and reduce abnormal cells, possibly lowering the risk of progression to cancer.
How similar studies have performed: Small case series and pilot reports of topical immune modulators for mucosal or skin precancerous lesions have shown promise, but well-controlled evidence specifically for oral dysplasia is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.