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NCT Number: NCT07210775

Topical Imiquimod Treatment of Oral Dysplasia

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.

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Key information

Conditions

Oral Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Leukokeratosis, Hereditary Mucosal Leukoplakia Leukoplakia Oral Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

OralCare PreCancer and Pain Clinic

Los Angeles, California, 90089, United States

Location status: Recruiting

Location contact

Anette Vistoso Monreal

CONTACT

[email protected]

(213) 821-0148

Anette Vistoso Monreal

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Frequency of Adverse Effects

    Time frame: 24 months

    Percentage of participants experienced at least 1 adverse events

  2. Manageability of Adverse effects

    Time frame: 24 months

    Percentage of adverse effect can not be managed by OTC medication

  3. Treatment Adherence

    Time frame: 24 months

    Percentage of patient with treatment adherence (≥80% Day adherence)

Study contacts

Contact information is provided by the study sponsor or research team.

Anette Vistoso Monreal

CONTACT

[email protected]

(213) 821-0148

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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