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

What this Trial Is About

Researchers are evaluating the use of topical imiquimod 5% cream to treat oral epithelial dysplasia, a precancerous condition affecting the mouth. This clinical trial aims to find out whether imiquimod can reduce the size of lesions and lessen abnormal cell changes, while also exploring how to make the treatment safer and easier to use. The study is sponsored by the University of Southern California and involves adult patients with biopsy-confirmed oral dysplasia who are not suitable for or decline surgical or laser therapy. Participants will apply the imiquimod cream daily for one hour, five days a week (Monday to Friday), over a six-week course. Depending on individual conditions and consent, additional treatment courses may be added. During the study, two follow-up biopsies will be performed at six months and twelve months after starting treatment to assess changes in the oral lesions. Throughout the trial, participants will be monitored for clinical and histological responses at 52 weeks after treatment begins. Safety will be evaluated by tracking the frequency and manageability of any side effects over 24 months, along with adherence to the treatment schedule. The study offers ongoing assessments to understand the effectiveness and feasibility of topical imiquimod for this condition.

Topical Imiquimod Treatment of Oral Dysplasia