Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ
Status:
Active, not recruiting
Trial end date:
2023-09-15
Target enrollment:
Participant gender:
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).