Topical Imiquimod Treatment of Oral Dysplasia

Not Applicable

Recruiting

• Conditions: Oral Dysplasia; Leukoplakia Oral; Leukoplakia
• Interventions: Drug: Imiquimod (topical use)

• Registration Number: NCT07210775
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients have topical imiquimod applied to oral dysplasia site	Imiquimod (topical use)	-

Primary Outcome Measures

Name	Time	Method
Effectiveness by Clinical Response	52 weeks after the start of the participant's treatment course	Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria
Effectiveness by histopathological assessment	52 weeks after the start of participant's treatment course	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Effects	24 months	Percentage of participants experienced at least 1 adverse events
Manageability of Adverse effects	24 months	Percentage of adverse effect can not be managed by OTC medication
Treatment Adherence	24 months	Percentage of patient with treatment adherence (≥80% Day adherence)

Trial Locations

Locations (1)

OralCare PreCancer and Pain Clinic; 🇺🇸 Los Angeles, California, United States