Ongoing Clinical Trials for Anogenital Dysplasia
This article provides information about ongoing clinical trials for anogenital dysplasia, a condition involving abnormal cell growth in the genital and anal areas. Currently, there is 1 clinical trial underway investigating new treatment approaches for this condition. The trial is focused on combining topical therapy with a chemical procedure to treat anal high-grade squamous intraepithelial lesions in adults.
Clinical trial locations
Study on the Effectiveness of Green Tea Extract and Trichloroacetic Acid for Treating Anal High-Grade Squamous Intraepithelial Lesions in Adults
This clinical trial is investigating a combined treatment approach for anal high-grade squamous intraepithelial lesions, also known as HSIL. These are abnormal cells that grow in the anal area and have the potential to develop into cancer if left untreated. The study tests whether combining two treatments works better than using just one.
Main focus and goal: The trial aims to determine how effective the combination of a green tea extract ointment called Sinecatechins and a chemical procedure using trichloroacetic acid is in eliminating HSIL after 48 weeks of treatment. Participants will be randomly assigned to receive either both treatments together or just the chemical procedure alone. The study will track whether the lesions improve, disappear, or return over time.
Investigational drugs: The study uses two main treatments:
- Sinecatechins 10% ointment – This is a topical treatment derived from green tea leaves that is applied directly to the affected area. It contains antioxidant properties that help inhibit the growth of abnormal cells.
- Trichloroacetic acid – This chemical is applied directly to the skin to destroy abnormal tissue, allowing healthy tissue to grow in its place.
Who can participate (inclusion criteria):
- Adults aged 18 years or older
- Individuals infected with HIV-1
- Individuals diagnosed with anal HSIL through a biopsy within the last 6 months
- Individuals who voluntarily agree to participate by signing an informed consent form
- Individuals capable of understanding and following the study’s instructions and requirements
- Individuals likely to complete the full study as planned
Who cannot participate (exclusion criteria):
- Patients who still have HSIL after 48 weeks of treatment
- Patients who do not respond to treatment with Sinecatechins 10% ointment when used alongside the ablative procedure
- Patients who experience a return of HSIL after treatment
- Patients who belong to vulnerable populations, which includes groups with limited ability to provide informed consent or who are at higher risk of harm from the study
What participants can expect: Upon joining the study, participants will sign an informed consent form and undergo an initial assessment to confirm eligibility. During the treatment phase, which lasts up to 48 weeks, participants will apply the Sinecatechins ointment to the affected area and undergo the trichloroacetic acid procedure. Regular follow-up visits will monitor progress and check for side effects. A final assessment at the end of 48 weeks will evaluate whether the lesions have been reduced or eliminated.
Summary
Currently, there is one clinical trial available for individuals with anogenital dysplasia, specifically targeting anal high-grade squamous intraepithelial lesions. This trial is being conducted in Spain and focuses on patients who are also living with HIV-1. The study investigates whether combining a topical green tea extract ointment with a chemical ablative procedure is more effective than the procedure alone. The trial represents an important step in exploring new treatment options for a condition that, if left untreated, has the potential to progress to cancer. Patients interested in participating should meet specific criteria, including having a recent HSIL diagnosis and the ability to follow study requirements over a 48-week period.