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Comparison of therapeutic effects and complications of 40% topical hydrogen peroxide solution with cryotherapy in genital wart lesions

Protocol summary

Study aim
The purpose of this study is to evaluate the effect of 40% topical hydrogen peroxide solution in patients with genital wart lesions.
Design
Randomized clinical trial with control group, with parallel groups, without blinding, , phase 3 on 40 patients. For randomization, closed envelopes with A and B written inside them were used.
Settings and conduct
This study was performed in Sina Hospital, Tabriz, dermatology ward, and there is no blinding. Patients in the intervention and control groups will be randomly evaluated using Sealed envelopes.
Participants/Inclusion and exclusion criteria
Patients over 18 years old ,having at least 1 genital wart ,Not using previous treatment, and consent to participate in the study will be included in the study. Pregnant and lactating women, patients who are afraid to use the treatment will be excluded from the study.
Intervention groups
In the intervention group, only local hydrogen peroxide solution (40% by volume) will be applied in one or two of their wart lesions and it will be kept for 20 seconds with rotating movements and pressure on the lesion. In each session, this cycle will be repeated 4 times, which will be 80 seconds in total.For other warts in this group, the standard treatment of genital warts (cryotherapy) will be performed. in control group only cryotherapy will be used.Medication (for the intervention group) and cryotherapy (for the control group) will be done in the first visit, the visit 3 weeks later, and the visit 6 weeks later, and each time the patients will be examined in terms of the effects of the treatment, efficacy and side effects of receiving the medicine And In the visit 8 weeks later, the patients will only be examined in terms of the effects of the treatment and the side effects of taking the medicine and will not receive any intervention.
Main outcome variables
Diameter and Height of warts. probable side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120524009844N10
Registration date: 2023-04-13, 1402/01/24
Registration timing: registered_while_recruiting

Last update: 2023-04-13, 1402/01/24
Update count: 0
Registration date
2023-04-13, 1402/01/24
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2023-05-04, 1402/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects and complications of 40% topical hydrogen peroxide solution with cryotherapy in genital wart lesions
Public title
Therapeutic effects and complications of hydrogen peroxide solution in genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 1 genital wart Satisfaction with the study Age above 18 years
Exclusion criteria:
Pregnant and beast feeder women Patients who are afraid to use treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by RandList software. The selection of patients will be based on sealed envelopes that be written A and B inside them. 40 envelopes will be prepared in two groups. After entering the clinic and before the visit, patients will receive the envelope from the secretary and hand it over to the physician.
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 Tabriz University of Medical Sciences
Street address
Sina Hospital, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.TBZMED.REC.1401.1005

Health conditions studied

1

Description of health condition studied
Genital wart
ICD-10 code
B07.8
ICD-10 code description
Other viral warts

Primary outcomes

1

Description
Diameter of warts
Timepoint
Weeks 0,3,6 and 8 after treatment
Method of measurement
Clinical examination and Measure by ruler

2

Description
Height of warts
Timepoint
Weeks 0,3,6 and 8 after treatment
Method of measurement
Clinical examination and measurement with caliper

3

Description
Probable side effects
Timepoint
Weeks 0,3,6 and 8 after treatment
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: In each patient, after examining the warts and relative matching according to the size and location, local 40% hydrogen peroxide solution will be used on one or two genital wart lesions in the intervention group. this solution will be used on the lesion to cover the entire surface of the lesion And then it will be kept for 20 seconds with rotating movements and pressure on the lesion. In each session, this cycle will be repeated 4 times, which will be 80 seconds in total. This intervention will be done at the beginning of the study and will be repeated in the third and sixth weeks if there is no improvement.For their other lesions, only standard genital wart treatment (cryotherapy) will be used.in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention.
Category
Treatment - Other

2

Description
Control group: The Control group will be treated with liquid nitrogen cryotherapy, using spray 1-2 cm away from the lesion for 20-30 seconds, depending on the size of the wart to create a white halo around the wart as much as 1 mm. Cryotherapy (for the control group) will be performed in the first visit, the visit 3 weeks later and the visit 6 weeks later, and each time the patients will be examined in terms of the effects of the treatment, efficiency and side effects of the treatment, and in the visit 8 weeks later, the patients will be evaluated only in terms of The effects of treatment, efficiency and side effects of receiving the drug have been checked and they will not receive intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mehdi Amirnia
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Central Building of Medical Sciences, Daneshgah Square.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Amirnia
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mehdi Anirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.
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