NCT04859361

Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ

Status unknown NA Last updated 3 May 2021

What this trial tests

NA trial testing Aldara 5% Topical Cream in Intraepithelial Neoplasia, Cervical in 104 participants. Status unknown.

Timeline

20 November 2018

Primary endpoint
21 April 2020

15 September 2023

Quick facts

Lead sponsor	University Medical Centre Maribor
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	104
Start date	20 November 2018
Primary completion	21 April 2020
Estimated completion	15 September 2023
Sites	1 location across Slovenia

Drugs / interventions tested

• Aldara 5% Topical Cream — full drug profile →
• LLETZ

Conditions studied

• Intraepithelial Neoplasia, Cervical — all drugs for Intraepithelial Neoplasia, Cervical →

Sponsor

University Medical Centre Maribor

Who can join

Adults 18 to 40, female only, with Intraepithelial Neoplasia, Cervical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
2. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
3. Plasmacytoid dendritic cells at the forefront of anti-cancer immunity: rewiring strategies for tumor microenvironment remodeling.
   Monti M, Ferrari G, Gazzurelli L, Bugatti M, et al · · 2024 · cited 22× · PMID 39020402 · DOI 10.1186/s13046-024-03121-9
4. Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial.
   Cokan A, Pakiž M, Serdinšek T, Dovnik A, et al · · 2021 · cited 14× · PMID 34945073 · DOI 10.3390/jcm10245777
5. Modulation of sHLA-G, PD-1, and PD-L1 Expression in Cervical Lesions Following Imiquimod Treatment and Its Association with Treatment Success.
   Cokan A, da Silva NCH, Kavalar R, But I, et al · · 2024 · PMID 38610950 · DOI 10.3390/cancers16071272