NCT07210775

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. 1.Does imiquimod help to make the lesions smaller and make the abnormal cell changes less severe?
  2. 2.How can we make this treatment safer and more feasible?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
17mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

September 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 4, 2026

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 18, 2025

Last Update Submit

March 3, 2026

Conditions

Oral DysplasiaLeukoplakia OralLeukoplakia

Keywords

oral dysplasialeukoplakiaprevent cancertopical application

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Frequency of Adverse Effects

    24 months

  • Manageability of Adverse effects

    24 months

  • Treatment Adherence

    24 months

Study Arms (1)

Patients have topical imiquimod applied to oral dysplasia site

EXPERIMENTAL
Drug: Imiquimod (topical use)

Interventions

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.

Patients have topical imiquimod applied to oral dysplasia site

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OralCare PreCancer and Pain Clinic

Los Angeles, California, 90089, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39007165BACKGROUND

MeSH Terms

Conditions

Leukokeratosis, Hereditary MucosalLeukoplakia

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPrecancerous ConditionsNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Anette Vistoso Monreal

CONTACT

(213) 821-0148avistoso@ostrow.usc.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of OralCare PreCancer and Pain Clinic

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 7, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 4, 2026

Record last verified: 2025-09

Locations

US(1)