Topical Imiquimod for Oral Precancerous Lesions

This trial tests whether a cream called imiquimod can safely and effectively treat oral dysplasia, a precancerous condition in the mouth. Researchers aim to determine if the cream can reduce the size and severity of lesions. Participants will apply the cream to the affected area and undergo two follow-up biopsies. This trial suits adults with a confirmed diagnosis of oral dysplasia who are not eligible for or do not want surgery or laser treatment. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage treatment development.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that imiquimod 5% cream might be a safe option for treating early signs of oral cancer. Studies suggest that imiquimod can help manage various mouth conditions, including these early signs, by slowing their progression into cancer.

Reports indicate that imiquimod is generally well-tolerated for treating oral dysplasia, an early-stage mouth condition. Although specific side effects are not mentioned, its ongoing testing in early trials means its safety is still under close observation.

The FDA has already approved imiquimod for other skin conditions, suggesting it might be safe. This trial aims to determine if it is also safe for use in the mouth.

Unlike standard treatments for oral precancerous lesions, which often involve surgical removal or laser therapy, Imiquimod is a topical cream that stimulates the immune system to target abnormal cells directly. This unique delivery method allows for a non-invasive approach, potentially reducing the need for more aggressive procedures. Researchers are excited about Imiquimod because it harnesses the body's own defenses, offering a promising alternative with potentially fewer side effects and disruptions to healthy tissue.

Research has shown that imiquimod 5% cream can effectively treat oral dysplasia, which are early signs of potential cancer in the mouth. One study found that it reduced the size of these lesions by 50% or more in 65.8% of cases. Another study suggested that imiquimod might help prevent these lesions from becoming cancerous. It has also successfully treated similar early-stage conditions on other moist body surfaces. In this trial, participants will receive topical imiquimod applied to the oral dysplasia site. Overall, imiquimod appears to be a safe and practical treatment option for reducing and managing oral dysplasia.¹²⁶⁷⁸