Imiquimod treatment of premalignant lesions of the uterine cervix.

TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001260-34-NL

Enrollment

210

Registered

2014-06-02

Start date

2014-09-09

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade cervical intraepithelial neoplasia.

Interventions

Trade Name: Aldara Product Name: Aldara Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - de novo, CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy, - 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - immuno-compromised women, - pregnant or lactating women, - legally incapable women, - previous high-grade CIN lesions

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions.;Secondary Objective: - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy. - To assess health-related quality of life before, during and after treatment. - To assess the incidence and severity of adverse effects of imiquimod and LLETZ treatment. - To assess long-term recurrence of disease after treatment, by cytological examinations.;Primary end point(s): The endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions after imiquimod or observational management, defined as regression to CIN 1 or less, at 20 weeks.;Timepoint(s) of evaluation of this end point: 20 weeks	—

Measure

Time frame

Main Objective: To investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions.;Secondary Objective: - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy. - To assess health-related quality of life before, during and after treatment. - To assess the incidence and severity of adverse effects of imiquimod and LLETZ treatment. - To assess long-term recurrence of disease after treatment, by cytological examinations.;Primary end point(s): The endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions after imiquimod or observational management, defined as regression to CIN 1 or less, at 20 weeks.;Timepoint(s) of evaluation of this end point: 20 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy. - Health-related quality of life before, during and after treatment. - incidence and severity of adverse effects of imiquimod and LLETZ treatment. - long-term recurrence of disease after treatment, by cytological examinations;Timepoint(s) of evaluation of this end point: - Biomarker model: baseline. - quality of life: baseline, 20 weeks and one year - adverse effects: 6, 10, 16 and 20 weeks. - recurrence: 6, 12 and 24 months.	—

Measure

Time frame

Secondary end point(s): - Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy. - Health-related quality of life before, during and after treatment. - incidence and severity of adverse effects of imiquimod and LLETZ treatment. - long-term recurrence of disease after treatment, by cytological examinations;Timepoint(s) of evaluation of this end point: - Biomarker model: baseline. - quality of life: baseline, 20 weeks and one year - adverse effects: 6, 10, 16 and 20 weeks. - recurrence: 6, 12 and 24 months.

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Countries

Netherlands

Contacts

Public ContactM. Koeneman

Maasticht University Medical Center

m.koeneman@alumni.maastrichtuniversity.nl0031433874767

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026