The aim of this study is the Evaluation of therapeutic effect of cryotherapy with TCA on anogenital wartst. This study is a randomized clinical trial. Population of patients with anogenital warts visit in dermatology clinic of sina hospital or sheikh olrayis clinic. Inclusion criteria: patients with anogenital warts that their disease was detected by the clinical or pathological evidence.
Exclusion criteria: patient with anogenital pathological defect and pregnancy. 100 patients were selected and randomly divided into two groups.
First group treatment with Cryotherapy and second group treatment with TCA. The study was began from 2012/6/21. The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up, recovery and complications the patient has been taking a careful history and physical examination as well as the series of experiments, two groups were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307153566N3
Registration date:2013-08-23, 1392/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-09, 1392/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of cryotherapy with TCA on anogenital warts
Public title
Therapeutic effect of TCA on anogenital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with anogenital warts that their disease was detected by the clinical or pathological evidence.
Exclusion criteria: patient with anogenital pathological defect and pregnancy.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tabriz University of Medical Sciences
Street address
Azady avenue/golgasht avenue
City
Tabriz
Postal code
Approval date
2013-05-08, 1392/02/18
Ethics committee reference number
9223
Health conditions studied
1
Description of health condition studied
Anogenital wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
Number of warts
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up.
Method of measurement
Physical exam
Secondary outcomes
1
Description
Skin irritation
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up.
Method of measurement
Physical exam
2
Description
Itching
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up.
Method of measurement
Physical exam
3
Description
Fever
Timepoint
The patients for eleven months and at weeks zero, one, two, three, and four, two months later, three months later, fiv months later e, seven months later, nine months later and eleven months later of treatment follow up.
Method of measurement
Physical exam
Intervention groups
1
Description
Intervention grup: treatment by TCA 40% and controled every two weeks for two mouths.
Category
Treatment - Drugs
2
Description
Control grupe: treatment by cryotherapy and controled every two weeks for two mounths.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr. Azimi
Street address
Sina hospital- Azadi avenue-Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, assistance research
Full name of responsible person
Dr. Meshkini
Street address
Golgasht avenue, Azady avenu tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, assistance research
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Other areas of specialty/work
Street address
Sina hospital, Azadi avenue
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Other areas of specialty/work
Street address
Sina hospital, Azadi avenue
City
Tabriz
Postal code
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)