Topical Imiquimod Treatment of Oral Dysplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Dysplasia Leukoplakia Oral Leukoplakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients have topical imiquimod applied to oral dysplasia site

Group Type EXPERIMENTAL

Imiquimod (topical use)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No