To assess the effect of intra-lesion injection of vitamin D3 versus cryotherapy on the treatment of plantar warts
Design
This is a randomized clinical trial, phase II, in which 192 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with plantar 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 drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Plantar warts,
Exclusion criteria:
Pregnancy or breastfeeding,
Immunodeficiency syndrome,
Presence of wound or infection or active dermal lesion on the plantar area,
History of convulsion
Intervention groups
Intervention group:
Intra-lesion injection of vitamin D3 0.75 mg every 3 weeks for 3 times plus topical ointment zinc oxide 1% twice daily for 2 weeks
Control group:
Cryotherapy of the wart for 20 second every 2 weeks for 5 times plus topical ointment zinc oxide 1% twice daily for 2 weeks
Main outcome variables
Primary outcome:
Improvement of plantar wart
Secondary outcome:
Side effects including pain, erythema, swelling, and pigmentation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N358
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
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
2020-05-04, 1399/02/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intra-lesion injection of vitamin D3 versus cryotherapy on the treatment of plantar warts: a randomized clinical trial
Public title
Effect of intra-lesion injection of vitamin D3 versus cryotherapy on the treatment of plantar warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Plantar warts,
Exclusion criteria:
Pregnancy or breastfeeding,
Immunodeficiency syndrome,
Presence of wound or infection or active dermal lesion on the plantar area
History of convulsion
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment 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 patient will be assigned to the intervention or 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
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.221
Health conditions studied
1
Description of health condition studied
Plantar wart
ICD-10 code
B07.0
ICD-10 code description
Plantar wart
Primary outcomes
1
Description
Improvement of plantar wart
Timepoint
Every 3 weeks in the intervention group and every 2 weeks in the control group for 2 months
Method of measurement
With physical examination
Secondary outcomes
1
Description
Side effects including pain, erythema, swelling, and pigmentation
Timepoint
Every 3 weeks in the intervention group and every 2 weeks in the control group for 2 months
Method of measurement
with physical examination
Intervention groups
1
Description
Intervention group: Intra-lesion injection of vitamin D3 0.75 mg every 3 weeks for 3 times plus topical ointment zinc oxide 1% twice daily for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Cryotherapy of the wart for 20 second every 2 weeks for 5 times plus topical ointment zinc oxide 1% twice daily for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Shima Baniardalan
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
shima_ba@hotmail.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 Shima Baniardalan
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
6517838695
Email
shima_ba@hotmail.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