Menu
Recruiting NCT07210775

Topical Imiquimod Treatment of Oral Dysplasia

Phase I / Phase II Interventional Oral Dysplasia Leukoplakia Oral Leukoplakia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Imiquimod (topical use).
Who it may be relevant to
Registry conditions: Oral Dysplasia, Leukoplakia Oral, Leukoplakia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments

Overview

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

  • Drug 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.

Primary outcome measures

  • Effectiveness by Clinical Response [Time frame: 52 weeks after the start of the participant's treatment course]
  • Effectiveness by histopathological assessment [Time frame: 52 weeks after the start of participant's treatment course]
Secondary outcome measures (3)
  • Frequency of Adverse Effects [Time frame: 24 months]
  • Manageability of Adverse effects [Time frame: 24 months]
  • Treatment Adherence [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • OralCare PreCancer and Pain Clinic — Los Angeles

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. PMID 39007165

Identifiers

NCT: NCT07210775 · HS-24-00015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗