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Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions

B

Barretos Cancer Hospital

Status and phase

Completed
Phase 2

Conditions

High Grade Intraepithelial Neoplasia
Cervix Cancer

Treatments

Drug: Imiquimod
Procedure: Control

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03233412
BarretosCH-20171

Details and patient eligibility

About

Cervical cancer is one of the leading malignancies affecting women, with 311,000 deaths in 2018, most of them seen in underdeveloped countries. This neoplasm has a pre-invasive state, such as cervical intraepithelial neoplasia (CIN), which is caused by HPV (Human Papillomavirus) infection. The female organism most often is able to eliminate the virus, especially in young patients. However, when the infection becomes persistent, especially for subtypes 16 and 18, the risk of CIN developing an increased. Cytological screening programs can efficiently and wirelessly do this. As high-grade intraepithelial lesions (CIN 2/3) are as demonstrated by worse regression rate, only 13.3% at one year, and higher risk for progression to invasive cancer. As CIN 2/3 need treatment, and as more therapies as they are excisional, which theoretically are better, however, they may compromise the reproductive future of women who are unthreatened, increasing the risk of preterm labor, premature rupture of amniotic membranes, low weight Birth and perinatal mortality. This relationship aroused interest in seeking alternative therapies. Decrease antiviral activity directed against HPV, associated with a higher rate of elimination of the infection. Immediate, an agent that stimulates like dendritic cells to producer cytokines and activates epithelial T cells. Imiquimode, when used in vulvar neoplasias, has been shown to be effective, presenting satisfactory results without treatment of CIN 2/3 of the uterine cervix, requiring a better scientific compilation. Based on these data, this study aims to evaluate the efficacy of topical immunomodulatory treatment for high-grade cervical intraepithelial lesions.

Enrollment

90 patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women between the ages of 25 and 50 with histological diagnosis of CIN 2/3;
  • Living 300 km or less from the city of Barretos-São Paulo / Brazil.

Exclusion criteria

  • Suspected adenocarcinoma (in situ or invasive) or invading squamous cell carcinoma by colposcopy and/or citology;
  • Being pregnant or breastfeeding;
  • Women with some immunodeficiency or transplanted;
  • Previous treatment history for CIN 2/3.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Control
Other group
Description:
Will be offered the standard treatment, which is the conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
Treatment:
Procedure: Control
Imiquimod
Experimental group
Description:
Will receive topical uterine cervix (Imiquimod) treatment for a period of 12 weeks with weekly applications (1x / week). 30-60 days afterwards they will be submitted to standard treatment with conization of the uterine cervix with loop electrosurgical excision procedure (LEEP).
Treatment:
Procedure: Control
Drug: Imiquimod

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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