Clinical trial · Interventional
Topical Imiquimod Treatment of Oral Dysplasia
Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukoplakia | — | UNRESOLVED | — |
| Leukoplakia Oral | — | UNRESOLVED | — |
| Oral Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod (topical use) | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients have topical imiquimod applied to oral dysplasia site
- interventionNames
- Drug: Imiquimod (topical use)
Primary outcomes (2)
- measure
- Effectiveness by Clinical Response
- timeFrame
- 52 weeks after the start of the participant's treatment course
- description
- Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria
- measure
- Effectiveness by histopathological assessment
- timeFrame
- 52 weeks after the start of participant's treatment course
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSroussi 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. PMID 39007165