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RecruitingInterventionalPhase 1/Phase 2

Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments

NCT ID: NCT07210775Sponsor: University of Southern CaliforniaLast updated: 2026-03-04

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.

Arms & interventions

  • DrugImiquimod (topical use)

    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.

Outcome measures

Primary

  • Effectiveness by Clinical Response

    Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria

    Time frame: 52 weeks after the start of the participant's treatment course

  • Effectiveness by histopathological assessment

    Evaluation of the changes of degree of dysplasia following the WHO three-tier grading of oral dysplasia in which Oral epithelial dysplasia is graded as mild, moderate, and severe.

    Time frame: 52 weeks after the start of participant's treatment course

Secondary

  • Frequency of Adverse Effects

    Time frame: 24 months

  • Manageability of Adverse effects

    Time frame: 24 months

  • Treatment Adherence

    Time frame: 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (1)

OralCare PreCancer and Pain Clinic

Los Angeles, California, 90089

Recruiting
Anette Vistoso Monreal · Contact
(213) 821-0148avistoso@ostrow.usc.edu
· Contact
avistoso@ostrow.usc.edu
Anette Vistoso Monreal · Principal Investigator

References

  • Sroussi H, Villa A, Alhadlaq MA, Ikeda K, Veluppillai S, Treister N, Monreal AV, Vacharotayangul P, Lodolo M, Woo SB. Imiquimod for the treatment of oral leukoplakia: A two-center retrospective study. Oral Dis. 2025 Feb;31(2):444-451. doi: 10.1111/odi.15069. Epub 2024 Jul 15.(PubMed)