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Topical Imiquimod Treatment of Oral Dysplasia

Topical Imiquimod Treatment of Oral Dysplasia

Recruiting
18 years and older
All
Phase 1/2

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Overview

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.

Eligibility

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 details
    Oral Dysplasia
    Leukoplakia Oral
    Leukoplakia

NCT07210775

University of Southern California

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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