Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ

• Status: Active, not recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Centre Maribor
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• newly diagnosed and previously untreated HSIL in women aged 18 to 35 years or up to 40 years in case of nulliparity;

• satisfactory colposcopy (i.e., fully visible lesion and transformation zone);

• negative pregnancy test;

• safe contraception;

• signed, informed consent.

Exclusion Criteria:

• previously diagnosed HSIL or AIS;

• previous LLETZ or classical conisation;

• concomitant vulvar or vaginal lesion or neoplasia;

• other malignancies;

• insufficient colposcopy;

• pregnancy or lactation;

• known hypersensitivity to imiquimod;

• any known contraindications to immunotherapy;

• known HIV or acute or chronic hepatitis;

• immune deficiency;

• participation in any other ongoing clinical trial.