Topical Imiquimod Treatment of Oral Dysplasia

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT07210775
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Leukoplakia
  • Leukoplakia Oral
  • Oral Dysplasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients have topical imiquimod applied to oral dysplasia site

Primary Outcome Measure

Effectiveness by Clinical Response [ Time Frame: 52 weeks after the start of the participant's treatment course ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OralCare PreCancer and Pain ClinicLos AngelesCalifornia90089
Anette Vistoso Monreal
[email protected]
(213) 821-0148
[email protected]
Anette Vistoso Monreal (PRINCIPAL_INVESTIGATOR)

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By research site
OralCare PreCancer and Pain Clinic· Los Angeles, CA

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