The purpose of this study is to evaluate the histological response rate of high-grade cervical intraepithelial lesions after using topical imiquimod 5% with the histological response as low-grade cervical intraepithelial neoplasia or less in the LEEP sample. In addition, one of the other goals of this study is to determine a model for predicting the response to Imiquimod treatment in patients with cervical neoplasia.
Design
About 80 patients (age 20 to 45 years old) who were diagnosed with high-grade cervical neoplasia (CIN2, 3) by biopsy were selected *randomly* and divided into two groups of 40 people using quadruple permutation blocks. They are divided into four groups: 1- the group receiving 5% Imquimod drug, 2- the group receiving LEEP treatment
Settings and conduct
About 80 patients (age 20 to 45 years old) who were diagnosed with high-grade cervical neoplasia (CIN2, 3) by biopsy were selected *randomly* and divided into two groups of 40 people using quadruple permutation blocks. 1- the group receiving Imiquimod drug, 2- the group receiving LEEP treatment.
For patients in the hospital, once a week with suitable study conditions and equipment, for 12 weeks, Imiquimod 5% (250 mg) cream is used in the transformation zone of the cervix. After that, the patient is subjected to LEEP to determine the response to the treatment, and the regression rate is checked compared to the opposite group. Tissue slides are analyzed and interpreted by a pathologist.
Participants/Inclusion and exclusion criteria
Age 20-45 years.
Diagnosis of high-grade cervical neoplasia.
Obtaining informed consent.
Intervention groups
1- The group receiving topical imiquimod 5%
2- The group receiving surgical treatment (LEEP)
Main outcome variables
Percentage of histological response as low grade or less cervical intraepithelial neoplasia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230811059116N1
Registration date:2023-09-23, 1402/07/01
Registration timing:prospective
Last update:2023-09-23, 1402/07/01
Update count:0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Nooshin Sarikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7796 1458
Email address
nooshin_wxw@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical Imiquimod5% in treatment of high-grade cervical neoplasias (CIN2,3)
Public title
The effect of topical Imiquimod5% in treatment of high-grade cervical neoplasias (CIN2,3)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-45 years old
Diagnosis of high-grade cervical neoplasia (CIN2,3)
Obtaining informed consent
Exclusion criteria:
Cortone therapy
Pregnancy
Suppressed immune system due to HIV or organ transplant
Prior treatment for HSIL
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical school of Iran University of Medical Sciences
Street address
Iran University of medical sciences, Hammat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.IUMS.FMD.REC.1401.411
Health conditions studied
1
Description of health condition studied
The recovery rate of high-grade cervical neoplasias
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical intraepithelial neoplasia (CIN)
Timepoint
12 weeks after using topical imiquimod cream5%
Method of measurement
Loop Electrosurgical Excision Procedure and histological examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group receiving topical imiquimod 5%, for patients in the hospital, once a week with suitable study conditions and equipment, imiquimod cream 5% (250 mg) (Quimocyte® Cream 5% - Kimia Kala Razi Pharmaceutical Companyis) used in the transformation zone of the cervix for 12 weeks. .
Category
Treatment - Drugs
2
Description
Control group: Group receiving Loop Electrosurgical Excision procedure (LEEP)