Investigating the effect of zinc nanoparticles on the transmission of HPV infection from a person infected with HPV virus
Design
A clinical trial with two patient groups, parallel treatment, balanced block randomization, and double-blind (The researcher and the participant). 70 patients were referred to Sinai Hospital.
Settings and conduct
In the group of this clinical trial at Sina Hospital in Tehran, Urology Research Centre, double-blind (patient and researcher) Weber balanced block randomization will be performed on 70 patients. Patients are divided into two groups: The first group, the Human papillomavirus sample, is taken 5 minutes after using the ointment containing zinc oxide nanoparticles.Second, the human papillomavirus sample will be taken 5 minutes after the local application of the placebo ointment on the wart (this ointment does not contain any nanoparticles and is used only to prevent the distorting effect in the study).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men between the ages of 18 and 60 who have obvious warts، Obtaining informed consent from patients.
Exclusion criteria: People who have received the Gardasil vaccine according to the previous indications.
Intervention groups
Intervention group: human papillomavirus sample,5 minutes after using ointment containing zinc nanoparticles
Control group: human papillomavirus sample, 5 minutes after topical application of placebo ointment on the wart (this ointment does not contain any nanoparticles and is used only to prevent the effect of confusion in the study).
Main outcome variables
Transmission of human papillomavirus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N21
Registration date:2023-11-12, 1402/08/21
Registration timing:prospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of zinc nanoparticles on the transmission of HPV infection from a person infected with HPV virus
Public title
Investigating the effect of zinc nanoparticles on the transmission of HPV infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men in the age range of 18 to 60 years who have prominent genital warts
Obtaining informed consent from patients
Exclusion criteria:
Men who have received the Gardasil vaccine according to the previous indications
Age
From 18 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the balanced block randomization method is used to generate blocks with size of 4. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the Sealdenvelop online site, the generated sequence will be available to a technician outside the research team. blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected, and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the group (Double G plus placebo: 30 patients) or (Double G plus theophylline: 30 patients).
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind, randomized clinical trial. The researcher and the participant will not know about the randomization method.
The present study is a double-blind, randomized clinical trial study.
The researcher and the participant will not know how to be placed in the control or intervention groups. In both groups, the same ointment made by Bonyakhte company is used. The first group is an ointment containing zinc oxide nanoparticles ، The Second group is a placebo ointment that does not contain any nanoparticles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees in Medical Medical Research
Street address
Room 604, Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.107
Health conditions studied
1
Description of health condition studied
Genital warts in the genitals of men
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
The use of zinc oxide nanoparticles on HPV transmission
Timepoint
Before and 5 minutes after topical application of the ointment
Method of measurement
Molecular diagnosis laboratory (Real Time PCR )
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sample of human papillomavirus, 5 minutes after using the ointment containing zinc oxide nanoparticles, 25% (every 100 grams contains 25 groups of drugs), Bonyakhte Technology Company, use it once on the wart and then take a sample.
Category
Treatment - Drugs
2
Description
Control group: human papillomavirus sample, 5 minutes after topical application of placebo ointment on the wart (Vaseline ointment that does not contain any nanoparticles and is used only to avoid the confounding effect in the study)، Bonyakhte Technology Company, use it once on the wart and then take a sample.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
mkaghamir@tums.ac.ir
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.