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Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ

NCT04859361 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-05-03

No results posted yet for this study

Summary

Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. LLETZ as standard treatment is possibly associated with premature labour, higher subfertility rate and a higher rate of spontaneous abortion. Since premature delivery is one of the most important causes of perinatal morbidity and mortality, alternative conservative methods for SIL treatment are constantly being evaluated. The immunomodulator imiquimod is one of the main target compounds for treating HSIL.

Primary objective: to establish the efficacy of treatment with imiquimod (experimental arm) and compare it to the standard treatment with LLETZ (control arm).

Secondary objective:

* incidence and severity of the side effects in both groups;
* need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm;
* modulatory effect of imiquimod on immunoregulatory molecules.

Study design: Single-centre randomized controlled intervention trial.

Study population: 104 women with HSIL (52 in each arm).

Intervention:

\- randomization in two arms:

1. Experimental arm (imiquimod): treatment for 16 weeks with 5% imiquimod.
2. Control arm (LLETZ).

Successful treatment in the experimental arm is defined as absence of histological HSIL in diagnostic biopsies at 20-week follow-up (4 weeks after treatment completion) and in the control arm successful treatment is defined as absence of cytological HSIL in cytology 6 months after LLETZ (same as in our national guidelines).

Conditions

  • Intraepithelial Neoplasia, Cervical

Interventions

DRUG

Aldara 5% Topical Cream

5% Imiquimod cream (1 sachet) will be administered via menstrual cup, before going to sleep, 3 times per week for 16 weeks. Menstrual cup will be inserted in the vagina for a duration of 6-8 hours. In case of severe side effects applications can be reduced to twice per week and if side effects are persistent, to once per week. For maximum control of cervical disease, control colposcopy with a PAP smear and a punch biopsy will be scheduled at 10 weeks to rule out progression, and at 20 weeks after treatment initiation to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present, and if there are any new lesions present, additional biopsies will be performed. In case of disease progression or persistence, treatment with LLETZ will be offered.

PROCEDURE

LLETZ

LLETZ will be performed in an outpatient setting with local anesthesia, using KLS Martin Maxium with loop devices ranging from 10 mm to 20 mm in size. The excision will be performed using monopolar current with a cut frequency set to 100-150 W. Treatment success will be evaluated in accordance with our national guidelines 24 weeks after the procedure using a PAP smear with or without a punch biopsy.

Sponsors & Collaborators

  • University Medical Centre Maribor

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-04-21
Completion
2023-09-15

Countries

  • Slovenia

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 NCT04859361 on ClinicalTrials.gov