This clinical trial aimed to study the effects of direct topical injection of tuberculin within the lesion in patients with resistant warts and to comparison the recovery rate of this method with conventional treatments. Resistant wart is defined as a wart which is sustain more than two years or did not respond to the conventional treatment or was not treated with a maximum of four sessions of cryotherapy. In an experimental study, 60 patients who has the criteria enter the study and will be randomly divided into two groups. The inclusion criteria is refractory warts. Exclusion criteria defined as pregnant and lactating mothers, who had a history of previous tuberculosis and those who has immunodeficiency. In the first group tuberculin wil be injected directly into the lesion and in the second group localized cryotherapy will be applied. To compare the two groups, the number, size, extent and location of the warts will be recorded before intervention and after each session and after 6 months follow-up data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407089844N3
Registration date:2014-08-01, 1393/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-01, 1393/05/10
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-10-08, 1392/07/16
Expected recruitment end date
2014-05-06, 1393/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison study of Intralusional injection of tuberculin vs cryotheraphy in treatment of resistance warts
Public title
The Comparison study of Intralusional injection of tuberculin vs cryotheraphy in treatment of resistance warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with resistant warts
Exclusion criteria:
Patients with Immunosuppression ; Pregnant weman and lactating mothers ; Patients with a history of TB.
Age
No age limit
Gender
Both
Phase
2-3
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 Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
5/4/7027
Health conditions studied
1
Description of health condition studied
Wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
2
Description of health condition studied
Wart
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Number of warts
Timepoint
4 to 6 times in 2 weeks interval from the onset of treatment
Method of measurement
By physical examination
2
Description
Size of warts
Timepoint
4 to 6 times in 2 weeks interval from the onset of treatment
Method of measurement
By physical examination
3
Description
Extent of warts
Timepoint
4 to 6 times in 2 weeks interval from the onset of treatment
Method of measurement
By physical examination
4
Description
Location of warts
Timepoint
4 to 6 times in 2 weeks interval from the onset of treatment
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
In the first group PPD or tuberculin antigen in an amount of 0/1 to 0/3 ml depending on the size of the lesion, injected intradermaly and in multiple warts it will be injected in two largest warts.
Category
Treatment - Other
2
Description
The second group will be treated with liquid nitrogen cryotherapy, using spray 1-2 cm away from the lesion for 20-30 seconds, depending on the size of the wart to create a white halo around the wart as much as 1 mm.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Sima Masoudnia
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sima Masoudnia
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave
City
Tabriz
Postal code
Phone
00
Fax
Email
simamasoudnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Dermatologist/Associate professor
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
00
Fax
Email
mehamiruo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Izadseresht
Position
Medical Student
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
00
Fax
Email
b.izadseresht@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)