Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
Recruiting
Phase 4
Interventional Study
HSIL, High-Grade Squamous Intraepithelial Lesions
Vaginal Microbiome
Biomarkers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 25 – 45
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 96 (estimated)
- Sponsor
- Barretos Cancer Hospital · Other
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About This Trial
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 wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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-g…
Contacts
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