Comparison of the effects of salicylic acid solutions versus Cryotherapy for the treatment of Extra genital wart on patients referred to the Farshchian hospital.
(1) Objective: Comparison of the effects of salicylic acid and Cryotherapy solutions to treat Extra genital wart.
(2) Design: Randomized clinical trial
(3) Setting and conduct: Compare the effectiveness of Cryotherapy and salicylic acid in the treatment of Extra Genital warts.
(4) Participants including major eligibility criteria: Inclusion criteria Extra genital wart; No an underlying disease such as diabetes; immunodeficiency; lack of medications that suppress the immune system; and more than 4 years of age and have at least two wart Exclusion criteria Individuals younger than 4 years; lactation; ulceration of the skin in the treatment of active disease; coagulation disorders active; Intolerance to cold; immune system dysfunction; People with cold urticarial.
(5) Intervention: In the group treated with Cryotherapy with liquid nitrogen and cotton wool buds used. Warts with a margin of 1 mm surrounding healthy skin for 5 to 20 seconds depending on the type and location will be frozen. If there is no improvement, Cryotherapy therapy was done once every two weeks and would be repeated up to five times. In the group salicylic acid in the same condition that Cryotherapy is one to three of its other warts that are based on randomly selected, considering the side effects once daily for 8 weeks done.
(6) Main outcome measures (variables): Warts healing based on gender of participants, type of wart, treatment history and age groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052328008N1
Registration date:2016-07-20, 1395/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of salicylic acid solutions versus Cryotherapy for the treatment of Extra genital wart on patients referred to the Farshchian hospital.
Public title
Compared the effect of salicylic acid and Cryotherapy in the treatment of warts.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Extra genital wart; No an underlying disease such as diabetes; immunodeficiency; lack of medications that suppress the immune system a; more than 4 years of age and have at least two wart.
Exclusion criteria
Individuals younger than 4 years; lactation; ulceration of the skin in the treatment of active disease; coagulation disorders active; Intolerance to cold; immune system dysfunction and people with cold urticarial.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
1
Registry name
.
Secondary trial Id
.
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics CommitteeHamadn University Medical ScienceHamadan
Street address
Hamadan University of Medical Sciences, Pazoehsh Crossroad, Faehmide St.
City
Hamadan
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.UMSHA.REC.1395.76
Health conditions studied
1
Description of health condition studied
Extragenital wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
The disappearance of or going Warts
Timepoint
At baseline, two weeks and, if no improvement up to 5 times in the Cryotherapy group
Method of measurement
Examination by dermatologist
Secondary outcomes
1
Description
Side effects, Such as erythema, pain and local irritation
Timepoint
2-5-7 week
Method of measurement
Physical examination
Intervention groups
1
Description
In group one, Cryotherapy was done with cotton swab dipped into liquid nitrogen and then applied on the warts for 5–20 seconds every week. If there is no improvement, Cryotherapy therapy was done once every two weeks and would be repeated up to five times.
Category
Treatment - Drugs
2
Description
In group two, 40% salicylic acid at the same illness that Cryotherapy is one to three other warts that are based on randomly selected was applied on the dry lesions with a cotton swab once daily for 8 weeks done. Both methods were done by a dermatologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Abbasali Hesari
Street address
Farshchian Sinai Medical Center, Mirzadeh Eshhgi St, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Said Bashirian
Street address
Vice Chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh St, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hamadan 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
Hamadan University Medical ScienceHamadan
Full name of responsible person
Abbasali Hesari
Position
Resident in Dermatology
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Mirzadeh Eshhgi St, Hamadan
City
Hamadan
Postal code
Phone
+98 81 2827 4184
Fax
Email
alihesari39@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Medical of ScienceHamadan
Full name of responsible person
Mohammad Reza Sobhan
Position
Assistant Professor (dermatologist)
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Mirzadeh Eshhgi St, Hamadan
City
Hamadan
Postal code
Phone
+98 81 2827 4192
Fax
Email
mreza_sobhan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Abbasali Hesari
Position
Resident in Dermatology
Other areas of specialty/work
Street address
Farshchian Sinai Medical Center, Mirzadeh Eshhgi St, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3428 9706
Fax
+98 81 3826 9808
Email
alihesari39@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)