]>
IRCT20230811059116N1 IRCT 2023-09-23 Iran University of Medical Sciences The effect of topical Imiquimod5% in treatment of high-grade cervical neoplasias (CIN2,3) The effect of topical Imiquimod5% in treatment of high-grade cervical neoplasias (CIN2,3) 2023-10-23 anticipated 80 Complete https://irct.ir/trial/72206 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 The recovery rate of high-grade cervical neoplasias. Intervention 1: 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. . Intervention 2: Control group: Group receiving Loop Electrosurgical Excision procedure (LEEP). Yes - There is a plan to make this available What will be shared: Part of the data, such as information related to the main outcome or similar, can be shared. When: The access period starts 6 months after the results are published. To whom: It will be available for researchers working in academic and scientific institutions, and also people who are working in industry can apply for them. Conditions: For use in research projects. Where to obtain: Email to : nooshin_wxw@yahoo.com How to obtain: Sending an email and requesting information and waiting a few days to receive an email response. Comments:
public Nooshin Sarikhani
Tehran, Hammet highway, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1445613131 +98 21 8670 2503 nooshin_wxw@yahoo.com Iran University of Medical Sciences scientific Somaye Noeiteymoordash
Firoozgar Hospital, Beh afarin St, Karim khan Zand St, Valiasr Square
Tehran Iran (Islamic Republic of) 0000000000 +98 21 8214 1000 noeiteymoordash.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 20-45 years old Diagnosis of high-grade cervical neoplasia (CIN2,3) Obtaining informed consent 20 years 45 years Female Cortone therapy Pregnancy Suppressed immune system due to HIV or organ transplant Prior treatment for HSIL Treatment - Drugs Treatment - Surgery 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. . Control group: Group receiving Loop Electrosurgical Excision procedure (LEEP) Cervical intraepithelial neoplasia (CIN). Timepoint: 12 weeks after using topical imiquimod cream5%. Method of measurement: Loop Electrosurgical Excision Procedure and histological examination. Iran University of Medical Sciences Approved 2022-11-09 Ethics committee of medical school of Iran University of Medical Sciences Iran University of medical sciences, Hammat highway, Tehran Tehran Tehran Iran (Islamic Republic of)