Protocol summary

Study aim
To assess the effect of topical nitric-zinc complex solution versus cryotherapy on the treatment of warts
Design
This is a randomized clinical trial, in which 108 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with warts referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 7 to 80 years, Affected with warts, Exclusion criteria: Pregnancy or breastfeeding, Presence of wound, infection or active dermal disease at the site of treatment, Active coagulopathy, Presence of immune disorders, History of treatment of warts in the past two months, Cold intolerance, History of convulsion, History of cold urticaria
Intervention groups
Intervention group: Topical nitric-zinc complex solution 95% (manufactured by Hamadan School of Pharmacy) for a maximum of 20 seconds once every two weeks up to a maximum of four times Control group: Liquid nitrogen cryotherapy (manufactured by Pishidad Gas Industrial Group) for a maximum of 20 seconds once every two weeks up to a maximum of four times
Main outcome variables
Wart diameter

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N395
Registration date: 2021-05-14, 1400/02/24
Registration timing: prospective

Last update: 2021-05-14, 1400/02/24
Update count: 0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical nitric-zinc complex solution versus cryotherapy on the treatment of warts: a randomized clinical trial
Public title
Effect of topical nitric-zinc complex solution versus cryotherapy on the treatment of warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 7 to 80 years, Affected with warts,
Exclusion criteria:
Pregnancy or breastfeeding, Presence of wound, infection or active dermal disease at the site of treatment, Active coagulopathy, Presence of immune disorders, History of treatment of warts in the past two months, Cold intolerance, History of convulsion, History of cold urticaria
Age
From 7 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 108
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.UMSHA.REC.1400.113

Health conditions studied

1

Description of health condition studied
Wart
ICD-10 code
B07
ICD-10 code description
Viral warts

Primary outcomes

1

Description
Measurement of wart diameter
Timepoint
Before intervention and one month after that
Method of measurement
With wart imaging

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Topical nitric-zinc complex solution 95% (manufactured by Hamadan School of Pharmacy) for a maximum of 20 seconds once every two weeks up to a maximum of four times
Category
Treatment - Drugs

2

Description
Control group: Liquid nitrogen cryotherapy (manufactured by Pishidad Gas Industrial Group) for a maximum of 20 seconds once every two weeks up to a maximum of four times
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Sasan Dogohar
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
sasandogohar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Sasan Dogohar
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sasandogohar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Sobhan
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mreza_sobhan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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