Oral DysplasiaPhase 1/2NCT07210775
Topical Imiquimod Treatment of Oral Dysplasia
A Phase 1/2 study testing Imiquimod (topical use) in people with Oral Dysplasia and Leukoplakia Oral, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Dysplasia, Leukoplakia Oral, Leukoplakia
- What is being tested?
- Imiquimod (topical use)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OralCare PreCancer and Pain Clinic
Los Angeles, California, 90089
Anette Vistoso Monreal, (213) 821-0148, avistoso@ostrow.usc.edu
avistoso@ostrow.usc.edu
About this study
Official title: Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
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:
- Does imiquimod help to make the lesions smaller and make the abnormal cell changes less severe?
- 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
- Oral Dysplasia, Leukoplakia Oral, Leukoplakia
- Being tested
- Imiquimod (topical use)
- Keywords
- oral dysplasia, leukoplakia, prevent cancer, topical application
- Medical subject headings
- Leukokeratosis, Hereditary Mucosal, Leukoplakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients have topical imiquimod applied to oral dysplasia site | Experimental | Not described Receives: Drug: Imiquimod (topical use) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness by Clinical Response
Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria
Measured: 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.
Measured: 52 weeks after the start of participant's treatment course
Secondary outcomes (3)
Frequency of Adverse Effects
Percentage of participants experienced at least 1 adverse events
Measured: 24 months
Manageability of Adverse effects
Percentage of adverse effect can not be managed by OTC medication
Measured: 24 months
Treatment Adherence
Percentage of patient with treatment adherence (≥80% Day adherence)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anette Vistoso Monreal, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210775
- Sponsor's protocol ID
- HS-24-00015
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39007165
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
- ClinicalTrials.gov ID
- NCT07210775
- Acronym / sponsor ID
- HS-24-00015
- Conditions
- Oral Dysplasia, Leukoplakia Oral, Leukoplakia
- Keywords
- oral dysplasia, leukoplakia, prevent cancer, topical application
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does imiquimod help to make the lesions smaller and make the abnormal cell changes less severe?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients have topical imiquimod applied to oral dysplasia site | Experimental | Drug: Imiquimod (topical use) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imiquimod (topical use)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. | Drug | Patients have topical imiquimod applied to oral dysplasia site |
Primary outcome
Effectiveness by Clinical Response
Time frame: 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
Time frame: 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.
3 secondary outcomes
Frequency of Adverse Effects
Time frame: 24 months
Manageability of Adverse effects
Time frame: 24 months
Treatment Adherence
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 39007165Sroussi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Imiquimod (topical use) in people with Oral Dysplasia and Leukoplakia Oral, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anette Vistoso Monreal ((213) 821-0148, avistoso@ostrow.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness by Clinical Response (time frame: 52 weeks after the start of the participant's treatment course). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.