This is a phase 3 parallel, self controlled clinical trial with before-after measurement for evaluating effectiveness of local WARTNER in the treatment of genital warts. Subjects are 20 more than 18 years old men with genital wart who has been referred to TUMS skin and leprosy diseases research center. Eligible patient are sufficiently informed about objectives, potential adverse events and method of responsiveness. Patients are referred to dermal lab and are given informed consent. after registration of patients, subject identification form is assigned to each patient. 20 patients are included. 2 random lesion are selected for each patient and WARTNER is used to treat one of them. The other lesion is considered as control. both lesions are photographed. All patients are recommended to clean the site and come again after 14 days. At that time, both lesions are assessed by size and clearance (total removal of lesion). Primary outcome is two week difference in size of the intervention lesion compared to control one.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811073200N1
Registration date:2015-04-11, 1394/01/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-11, 1394/01/22
Registrant information
Name
Kazem Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 5948
Email address
k_heidari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Manoosha-Daru pharmaceutical Co.
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A parallel, self-controlled clinical trial to determine the healing effect of WARTNER in male patients with genital wart
Public title
Efficacy of WARTNER anti-wart local drug on genital warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male sex, >= 18 years old of age, at least 2 genital wart lesion approved by dermatologist, consent to participate and being followed for visits, consent to discontinue the other anti-genital wart drugs
Exclusion criteria: diagnosed case of diabetes mellitus, Drug addiction, Other STDs, HIV positive, other immunodeficiency diseases, active skin lesion in genital ares, serious adverse event or intolerance to previous cryotherapy , cold sensitivity history, any tattoo, scar or pigmentation in the field of intervention which could affect the evaluation of the site, Being in the waiting list or participation in another cryotherpy trial at the same time of our study
Age
From 18 years old to 139 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences, ethics committee
Street address
TUMS central building, Keshavarz Blvd.
City
Tehran
Postal code
1346694135
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
94-01-159-28140-141082
Health conditions studied
1
Description of health condition studied
Genital wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts
Primary outcomes
1
Description
intervention and control lesion size
Timepoint
Days 0 and 14
Method of measurement
Caliper and Camera
Secondary outcomes
1
Description
Clearance of lesion
Timepoint
Day 14
Method of measurement
Observation and photography
2
Description
Adverse event
Timepoint
2 weeks after intervention
Method of measurement
Patient information
3
Description
lesion recurrence
Timepoint
6 weeks after intervention
Method of measurement
observation
Intervention groups
1
Description
Control lesion: no intervention
Category
N/A
2
Description
Intervention lesion: according to instruction, applicator is placed in sponge section. Then aerocele can is contacted to applicator and sponge is cryoliquid polluted. After waiting for 20 seconds, applicator is placed on the intervention lesion for 20 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Alireza Firooz
Street address
No. 415, Taleqni Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Manoosha-Daru
Full name of responsible person
Dr Mohamad Asnavandi
Street address
Unit 9, 3rd floor, No 12, 4th alley, in front of Tehran clinic, Ghaem-magham street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Manoosha-Daru
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
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Alireza Firooz
Position
Professor
Other areas of specialty/work
Street address
No. 415, Taleqni Ave
City
Tehran
Postal code
1416613675
Phone
+98 88972220
Fax
Email
FIROZALI@TUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Alireza Firooz
Position
Professor
Other areas of specialty/work
Street address
No. 415, Taleqni Ave
City
Tehran
Postal code
1416613765
Phone
+98 88972220
Fax
Email
FIROZALI@TUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center For Research And Training In Skin Diseases And Leprosy
Full name of responsible person
Alireza Firooz
Position
Professor
Other areas of specialty/work
Street address
No. 415, Taleqni Ave
City
Tehran
Postal code
1416613675
Phone
+98 88972220
Fax
Email
FIROZALI@TUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)