Comparison of combination of crayotherapy & multipuncture intralesional injection of bleomycin and cryotherapy alone in treatment of resistant palmaplanter Warts
Effect of combination of cryotherapy and intralesional bleomycin injection in treatment of recalcitrant palmoplantar warts
Design
This is a randomized, double-blind, parallel-group, controlled phase III study. In this study, 60 patients with hand and foot resistant palmoplantar warts will be randomly divided into two groups of 30 in each, using RandList software. The control group will only receive cryotherapy and in the intervention group, in addition to cryotherapy, intraleisional injection of bleomycin will be performed.
Settings and conduct
Sixty patients with palmoplantar warts who will refer to Sina Hospital Dermatology Clinic will randomly be assigned into two groups of 30 subjects, intervention group (cryotherapy and intraleisional injection of bleomycin) and the control group (cryotherapy).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18- 50 years old patients with recalcitrant palmoplantar wart for more than 2 years.
Exclusion criteria: Patients with injection phobia; Patients with Raynaud or Rheumatologic disorder history; Patients with allergy to local anesthetics.
Intervention groups
Intervention group: Cryotherapy and intraleisional injection of bleomycin.
In the intervention group, 30 patients with palmoplantar warts will be treated with cryotherapy in combination with intraleisional injection of bleomycin (1 mg/ml) at the start of the study, and in case of failure at weeks 3 and 6 of the study.
Control group: Only cryotherapy
In the control group, 30 patients with palmoplantar warts will be treated with cryotherapy at the onset of the study and in case of failure, in the third and sixth weeks of the study.
Main outcome variables
Number of warts; diameter of the largest wart; rate of Improvement; probable side effects; relapse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120524009844N6
Registration date:2019-04-08, 1398/01/19
Registration timing:prospective
Last update:2019-04-08, 1398/01/19
Update count:0
Registration date
2019-04-08, 1398/01/19
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
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combination of crayotherapy & multipuncture intralesional injection of bleomycin and cryotherapy alone in treatment of resistant palmaplanter Warts
Public title
Evaluation of intralesional injection and multipuncture of bleomycin in resistant palmaplanter Warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with palmoplantar wart resistant to treatment
Have disease for more than 2 years
Patients with age range of 18- 50 years old
Exclusion criteria:
Patients with Injection phobia
Patients with Raynaud or Rheumatologic disorder history
Patients with allergy to local anesthetics
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization will be carried out on an individual basis by RandList software. The allocation will be sealed by an independent monitor and will not be broken until the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator assessing outcome and analyzing the data will be blinded to treatment allocation until the end of the study.
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
Sina Hospital, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.TBZMED.REC.1397.817
Health conditions studied
1
Description of health condition studied
resistant palmaplanter Warts
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Numbers of Warts
Timepoint
weeks 0,3,6 and 9
Method of measurement
Counting
2
Description
Diameter of the largest wart
Timepoint
Weeks 0,3,6,9
Method of measurement
Measure by ruler
Secondary outcomes
1
Description
Improvement
Timepoint
Weeks 3, 6, 9
Method of measurement
Observation
2
Description
Probable side effects
Timepoint
Weeks 3, 6, 9
Method of measurement
Observation
3
Description
Disease relapse
Timepoint
weeks 3, 6, 9
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Cryotherapy and intraleisional injection of bleomycin. In the intervention group, 30 patients with palmoplantar warts will be treated with cryotherapy in combination with intraleisional injection of bleomycin (1 mg/ml) at the start of the study, and in case of failure at weeks 3 and 6 of the study.
Category
Treatment - Other
2
Description
Control group: Only cryotherapy In the control group, 30 patients with palmoplantar warts will be treated with cryotherapy at the onset of the study and in case of failure, in the third and sixth weeks of the study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mehdi Amirnia
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ataa Mahmoudpour
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
mehamir46@gmail.com
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
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
Tabriz University of Medical Sciences
Full name of responsible person
دکتر مهدی امیرنیا
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mehdi Anirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after being unidentified.
When the data will become available and for how long
At any time
To whom data/document is available
It will be free for everyone.
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Email: mehamir46@gmail.com
Dr Mehdi Amirnia
09143113577
Dermatology Department - Sina Hospital- Azadi Street- Tabriz
What processes are involved for a request to access data/document
The Request will be checked, then data will be sent by Email in 1 month.