Leukoplakia, Leukoplakia Oral, Oral Dysplasia
Conditions
Keywords
oral dysplasia, leukoplakia, prevent cancer, topical application
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.
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.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
CONTACTAnette Vistoso Monreal
Outcome results
None listed