Residual or recurrent Cervical Intraepithelial Neoplasia (CIN)
Conditions
Interventions
Trade Name: Imiquimod (aldara) creme 5%
Product Name: Imiquimod 5% creme
Pharmaceutical Form: Cream
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven CIN2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis - Histologically proven persistent CIN 1 after previous surigcal treament at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology - The patient is willing to use a medically acceptable method of contraception throughout the study - Women older than 18 years of age 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 410 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or lactation - (Micro-)invasive carcinoma - Past history of cervical cancer - Hypersensitivity of any components of the formulation - History of psoriasis or other inflammatory dermatosis of the vulva - Immunodeficiency or treatment with immunosuppressive medication - Insufficient understanding of the Dutch or English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of imiquimod 5% cream compared to treatment with Large Loop excision of the transformation zone (LLETZ) for recurrent/residual CIN.;Secondary Objective: Evaluation of the effect of treatments on HPV DNA presence in CIN lesions Evaluations of tolerability of imiquimod in CIN lesions Evaluation of quality of life Establishment of long term recurrence rate of CIN lesions;Primary end point(s): - Reduction from CIN 2-3 or persistent CIN 1 to normal cytology 6 months after start treatment.;Timepoint(s) of evaluation of this end point: 6 months after start treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Presence or absence of HPV DNA in CIN lesions at 0 and 26 weeks. o Reduction from CIN to no dysplasia 10 weeks after the treatment with imiquimod. o Improvement in quality of life o Side effects of imiquimod o Durability of the clinical response at 12 and 24 months o Long term recurrence defined by follow up in the screening program for cervical cancer in The Netherlands ;Timepoint(s) of evaluation of this end point: - 10 weeks after treatment with imiquimod - at inclusion, 6 and 12 months after treatment - during the treatment with imiquimod - 12 and 24 months after start treatment - first cervical smear according to dutch screening program | — |
Countries
Netherlands
Outcome results
None listed