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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:
Participants will apply topical imiquimod cream to treat the oral dysplasia and receive two follow-up biopsies after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients have topical imiquimod applied to oral dysplasia site | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod (topical use) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness by Clinical Response | Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria | 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. | 52 weeks after the start of participant's treatment course |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Effects | Percentage of participants experienced at least 1 adverse events | 24 months |
| Manageability of Adverse effects | Percentage of adverse effect can not be managed by OTC medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anette Vistoso Monreal | Contact | (213) 821-0148 | avistoso@ostrow.usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OralCare PreCancer and Pain Clinic | Recruiting | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39007165 | Background | Sroussi H, Villa A, Alhadlaq MA, Ikeda K, Veluppillai S, Treister N, Monreal AV, Vacharotayangul P, Lodolo M, Woo SB. Imiquimod for the treatment of oral leukoplakia: A two-center retrospective study. Oral Dis. 2025 Feb;31(2):444-451. doi: 10.1111/odi.15069. Epub 2024 Jul 15. |
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| ID | Term |
|---|---|
| D053529 | Leukokeratosis, Hereditary Mucosal |
| D007971 | Leukoplakia |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| 24 months |
| Treatment Adherence | Percentage of patient with treatment adherence (≥80% Day adherence) | 24 months |
| D017437 | Skin and Connective Tissue Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |