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A randomized controlled study to assess the efficacy of topical Sinecathechins used as adjuvant therapy to topical ablative trichloroacetic acid in the Treatment of anal High grade squamous intraepithelial lesion.
EU CTIS ID: 2024-519782-21-00
What this study is testing
To describe the proportion of patients free of HSIL at 48 weeks of treatment, defined as a complete or partial response (regression from HSIL to normal or LSIL, respectively) and free of recurrence, with topical Sinecatechins 10% ointment used as adjuvant therapy to ablative treatment, compared with ablative treatment alone.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults ≥ 18 years of age.
- HIV-1 infected individuals
- Individuals with biopsy-proven anal HSIL within 6 months prior to the study.
- Voluntary signature of the informed consent.
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Be likely to complete the study as planned.
You likely can't join if
- Any disease or condition of the patient that, in the opinion of the investigator, is not suitable for participation in the study.
- Individuals who have received prior anal HSIL treatment in the last 3 months.
- Individuals with two or more recurrences of anal HSIL in the last 2 years.
- Individuals unable to understand the study protocol or any other condition that in the opinion of the investigator may compromise compliance with the protocol.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.