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Imiquimod Treatment of High-grade CIN

NCT02917746 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-16

No results posted yet for this study

Summary

This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod.

120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference:

1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks.
2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

Imiquimod

Patients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy.

PROCEDURE

Large Loop Excision of the Transformation Zone

Patients in this group are treated with LLETZ.

Sponsors & Collaborators

  • Clinical Trial Center Maastricht B.V.

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • A.J. Kruse, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-07-31
Completion
2020-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02917746 on ClinicalTrials.gov