High prevalence of Wart and its impact on patient's social life necessitates efficacious ,economical and safe therapeutic interventions. This study is a randomized controlled clinical trial aiming to evaluate the efficacy and safety of of thermotherapy in the treatment of wart. Sixty patients with the age of eighteen and above who have warts on trunk and limbs with no history of intolerance to cold and heat, diabetes mellitus, peripheral vascular disease, immunodeficiency, treatment of wart during the last three months and are not pregnant and breast feeding would be included. They will be randomized into two groups of cryotherapy and thermotherapy. In cryotherapy group the treatment would be done every two weeks for a maximum of six sessions. The final follow-up is three months after the last session of cryotherapy. In thermotherapy group we would do the treatment for just one session and then patient would be visited every two weeks for three months. In each visit the size of wart, side effects and patients' satisfaction would be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010120514N1
Registration date:2015-01-25, 1393/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2015-02-15, 1393/11/26
Expected recruitment end date
2016-02-15, 1394/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy and safety of thermotherapy and cryotherapy in the treatment of wart
Public title
The efficacy and safety of heattherapy and coldtherapy in the treatment of wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 years old and above; less than 10 warts; signed informed consent voluntarily and knowingly. Exclusion criteria: being treated during the last two months; warts on the face and genital; plane warts; pregnancy; breast feeding; intolerance to heat; intolerance to cold; diabetes mellitus; peripheral vascular disease; immunodeficiency.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 in Research Committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences , Ghods intersection , Keshavarz blvd.
City
Tehran
Postal code
1417653761
Approval date
2014-12-07, 1393/09/16
Ethics committee reference number
9111166002-1
Health conditions studied
1
Description of health condition studied
wart
ICD-10 code
12
ICD-10 code description
B07
Primary outcomes
1
Description
Disappearing of wart
Timepoint
Before the intervention, every month in thermotherapy group after discontinuation of tretment for three month and in cryotherapy group before the intervention and every two weeks for the maximum six sessions and then 3 months after the discontinuation of treatment
Method of measurement
physical examination, Digital photography, patient's satisfaction
Secondary outcomes
1
Description
Blister
Timepoint
After each session of intervention
Method of measurement
Asking patients
2
Description
Ulcer
Timepoint
After each session of intervention
Method of measurement
Asking patients
3
Description
Infection
Timepoint
After each session of intervention
Method of measurement
Asking patients
Intervention groups
1
Description
Intervention group : Thermotherapy once
Category
Treatment - Other
2
Description
Control group: Cryotherapy every two weeks until warts are removed or for maximum six sessions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Leila Izadi Firouzabadi
Street address
Vahdat-Eslami Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Reasearch of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Central Construction of Tehran University of Medical Sciences , Ghods intersection , Keshavarz blvd. Vice chancellor for research of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Reasearch of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Leila Izadi Firouzabadi
Position
Resident of dermatology
Other areas of specialty/work
Street address
Vahdate-Eslami Square
City
Tehran
Postal code
119963911
Phone
+98 21 5566 4089
Fax
+98 21 5562 0300
Email
lilaizadi@yahoo.com
Web page address
razidermgroup.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Leila Izadi Firouzabadi
Position
Resident of dermatology
Other areas of specialty/work
Street address
Vahdat-Eslami Square
City
Tehran
Postal code
119963911
Phone
+98 21 5566 4089
Fax
+98 21 5562 0300
Email
lilaizadi@yahoo.com
Web page address
razidermgroup.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Leila Izadi Firouzabadi
Position
Resident of dermatology
Other areas of specialty/work
Street address
Vahdat-Eslami Square
City
Tehran
Postal code
119963911
Phone
+98 21 5566 4089
Fax
+98 21 5562 0300
Email
lilaizadi@yahoo.com
Web page address
razidermgroup.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)