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New treatment option for HSIL, High-Grade Squamous Intraepithelial Lesions
Official title Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
ClinicalTrials.gov ID: NCT06356012
What this study is testing
What is Imiquimod?
Imiquimod is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for hsil, high-grade squamous intraepithelial lesions.
Also referred to as IXIUM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Patients between 25 and 45 years of age (reproductive age);
- High-risk HPV carriers;
- Residents less than 300 km from the city of Barretos-São Paulo;
- With a histological diagnosis of high-grade cervical squamous intraepithelial lesion (CIN 3), obtained through colposcopy-guided biopsy performed at...
- Acceptance of the Informed Consent Form.
You likely can't join if
- Suspicion of invasive squamous cell carcinoma or Adenocarcinoma (in situ or invasive) by colposcopy and/or cytology;
- Pregnant or breastfeeding;
- Immunodeficiency condition;
- Previous treatment for high-grade cervical squamous intraepithelial lesion;
- Who have been immunized for HPV;
- Have used antibiotics in the last 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Barretos, Brazil
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 female, 25 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barretos, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.