Comparative study on the efficacy of two methods of cryotherapy with intralesional injection of bleomycin in treatment of anogenital wart in patients referred to Shohada-e-Tajrish and Loghman Hakim Hospitals in Tehran in 2019-2020
Design
Patients are divided into two groups of 30. Also, to randomize the treatment, patients receive two envelopes, one containing "cryotherapy" phrase and one containing "bleomycin" phrase on a piece of paper, and the patient randomly selects one of them.
Settings and conduct
This study is carried out at dermatology clinics of Shohada Tajrish Hospital and Loghman Hakim Hospital,which based on the selected treatment modality the cryotherapy group are treated with liquid nitrogen by cotton swab while the other group recieve intra-lesional bleomycin.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Over 18 years old; informed consent.
Exclusion criteria: Immunodeficiency; Drug allergies; Other co-morbidities such as anogenital herpes infection; Vascular problems; Pregnant or breast feeding; Being under treatment in the last 4 weeks (such as cryotherapy or Imiquimod ointment); Warts on the shaft of penis.
Intervention groups
Intervention group 1: Cryotherapy of anogenital wart
Intervention group 2: Intra-lesional injection of bleomycin
Main outcome variables
Treatment of Anogenital wart
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190519043631N1
Registration date:2019-12-30, 1398/10/09
Registration timing:registered_while_recruiting
Last update:2019-12-30, 1398/10/09
Update count:0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Nasim Gholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2281 7237
Email address
nasim.gholizadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the efficacy of cryotherapy and intralesional injection of Bleomycin in treatment of anogenital wart
Public title
The efficacy of two methods of cryotherapy with intralesional injection of Bloemycin in treatment of anogenital wart
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anogenital wart referred to Loghman Hakim and Shohada-e-Tajrish hospitals during the years 2019-2020
Age over 18 years old
Having informed consent to participate in the study
Exclusion criteria:
Immunodeficiency
Drug allergy
Other comorbidities such as herpes at the anogenital site
Pregnancy and breast feeding
Vascular disorders
Receiving other treatments in the last 4 weeks (For example Cryotherapy or Imiquimod Ointment)
Wart on shaft of penis
Age
From 18 years old
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
To randomize the treatment, patients receive two envelopes, one containing "cryotherapy" phrase and one containing "bleomycin" phrase on a piece of paper, and the patient randomly selects one of them.
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 Shahid Beheshti University of Medical Sciences
Street address
Shohada hospital , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2019-04-14, 1398/01/25
Ethics committee reference number
IR.SBMU.SRC.REC.1398.002
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
Treatment of Anogenital wart
Timepoint
At 3-week intervals for 3 times
Method of measurement
Observation by dermatology resident
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cryotherapy ; Liquid nitrogen is applied with a cotton swab on lesions for two Freeze-Taw cycles and then intra-lesional normal saline is injected as a placebo.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intralesional injection of bleomycin ; The bleomycin vial 15 mg is dissolved in 5 cc normal saline and injected at 2: 1 ratio with lidocaine into the lesions (equivalent to 2 mg /ml).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-e-Tajrish Hospital
Full name of responsible person
Nasim Gholizadeh
Street address
Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nasim.gholizadeh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shohada Hospital , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nasim.gholizadeh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohada Hospital , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nasim.gholizadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Loghmn Hakim Hospital; Makhsus street, Lashgar intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2281 7237
Fax
Email
nasim.gholizadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Gholizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shohada Hospital , Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
nasim.gholizadeh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available