Topical Imiquimod Treatment of Oral Dysplasia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Imiquimod (topical use)
DrugParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients have topical imiquimod applied to oral dysplasia siteExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness by Clinical Response
Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria
Time frame
52 weeks after the start of the participant's treatment course2
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.
Time frame
52 weeks after the start of participant's treatment courseSecondary outcomes
1
Frequency of Adverse Effects
Percentage of participants experienced at least 1 adverse events
Time frame
24 months2
Manageability of Adverse effects
Percentage of adverse effect can not be managed by OTC medication
Time frame
24 months3
Treatment Adherence
Percentage of patient with treatment adherence (≥80% Day adherence)
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov