Recruiting
Phase 1
Phase 2

Imiquimod

Sponsor:

University of Southern California

Code:

NCT07210775

Conditions

Oral Dysplasia

Leukoplakia Oral

Leukoplakia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imiquimod (topical use)

Study Details

Brief 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.

Conditions

Oral Dysplasia

Leukoplakia Oral

Leukoplakia

Study ID

NCT07210775

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients have topical imiquimod applied to oral dysplasia site

Interventions

Imiquimod (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.

Primary outcome measure

  • Effectiveness by Clinical Response [ Time Frame: 52 weeks after the start of the participant's treatment course ]
  • Effectiveness by histopathological assessment [ Time Frame: 52 weeks after the start of participant's treatment course ]

Central Contacts and Locations

Central contacts

Anette Vistoso Monreal

(213) 821-0148avistoso@ostrow.usc.edu

Locations

OralCare PreCancer and Pain Clinic

Recruiting

Los Angeles, California, United States, 90089

Contacts

Anette Vistoso Monreal

(213) 821-0148avistoso@ostrow.usc.edu

avistoso@ostrow.usc.edu

Principal Investigator:

Anette Vistoso Monreal

More Information

Sponsor

University of Southern California

Last update posted

Mar 4, 2026

Last verified

Sep, 2025

Keywords

  • oral dysplasia
  • leukoplakia
  • prevent cancer
  • topical application

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-03-04.