Topical Imiquimod Treatment of Oral Dysplasia

Phase 2RecruitingNCT07210775

University of Southern California20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oral Dysplasia Leukoplakia Oral Leukoplakia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

Frequency of Adverse Effects

Percentage of participants experienced at least 1 adverse events

Time frame: 24 months

Manageability of Adverse effects

Percentage of adverse effect can not be managed by OTC medication

Time frame: 24 months

Treatment Adherence

Percentage of patient with treatment adherence (≥80% Day adherence)

Time frame: 24 months

Topical Imiquimod Treatment of Oral Dysplasia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts