To compare the effect of CO2 laser versus cryotherapy on the treatment of plantar warts
Design
This is a randomized clinical trial, phase II, in which 66 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with plantar warts who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in the trial and the right and left side of the patients will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 6 to 80 years;
Bilateral plantar warts.
Exclusion criteria:
Pregnancy or breastfeeding;
Immunodeficiency;
Active skin disease;
Coagulopathy.
Intervention groups
Intervention group:
CO2 laser with a power of 10 to 30 W one or two pulse every two weeks for 2 months
Control group:
Cryotherapy using liquid nitrogen for 20 seconds once every two weeks for 2 months
Main outcome variables
Improvement of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N275
Registration date:2019-05-11, 1398/02/21
Registration timing:prospective
Last update:2019-05-11, 1398/02/21
Update count:0
Registration date
2019-05-11, 1398/02/21
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of CO2 laser versus cryotherapy on the treatment of plantar warts: a randomized clinical trial
Public title
Comparison of the effect of CO2 laser versus cryotherapy on the treatment of plantar warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 6 to 80 years
Bilateral plantar warts
Exclusion criteria:
Pregnancy or breastfeeding
Immunodeficiency
Active skin disease
Coagulopathy
Age
From 6 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the right side of the patient will be assigned to the intervention and the other side to the control group.
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
2019-04-27, 1398/02/07
Ethics committee reference number
IR.UMSHA.REC.1398.009
Health conditions studied
1
Description of health condition studied
Plantar warts
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Assessing the improvement of the lesion
Timepoint
2 months after the intervention
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: CO2 laser with a power of 10 to 30 W one or two pulse every two weeks for 2 months
Category
Treatment - Other
2
Description
Control group: Cryotherapy using liquid nitrogen for 20 seconds once every two weeks for 2 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Dr Faeze Mohammadi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
faeze.m2991@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 Faeze Mohammadi
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
faeze.m2991@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
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
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