This single blind clinical trial will be performed on patients with Palmoplantar warts referred to Bou-Ali Sina Hospital of Sari in 2016. Patients are divided into two groups of intervention and control using random numbers. for the intervention group, intralesional injection of MMR vaccine made by Razi institute and for the control group intralesional injection of normal saline made by the same institute is performed. Dose of the drug in the control group is 0.3mL and in MMR group it is determined based on positive reaction diameter. Diameter reaction less than 20mm recieves 0.3mL MMR, diameter of 20-40mm receives 0.2mL and diameter >40mm receives 0.1mL MMR vaccine. Injections are done with an interval of 2 weeks for up to 5 injections. During each session, photographs of lesions are taken and response to treatment is compared with the previous session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101027636N3
Registration date:2017-06-11, 1396/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Ghasem Rahmatpour Rokni
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3322 1755
Email address
gh.rahmatpour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Mazandaran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effect of intradermal injection of MMR vaccine in treatment of Palmoplantar warts in patients unresponsive to treatment
Public title
The therapeutic effect of intradermal injection of Measles, Mumps, and Rubella vaccine in treatment of palmoplantar warts in patients unresponsive to treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with Palmoplantar warts
Exclusion criteria: Acute febrile disease; treatment of warts within last month; History of allergic reaction to MMR vaccine; asthma; history of allergic skin disease such as eczema and hives, meningitis, seizure, primary or iatrogenic immunodeficiency; pregnancy; lactation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
NO.2 Building of Mazandaran University of Medical Sciences, Moallem Square, Sari
City
Sari
Postal code
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.MAZUMS.REC.95.1482
Health conditions studied
1
Description of health condition studied
Viral warts
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Wart size
Timepoint
0-2-4-6-8-10 Weeks
Method of measurement
Wart observation
2
Description
Number of warts
Timepoint
0-2-4-6-8-10 Weeks
Method of measurement
Observation
3
Description
Size of other lesions
Timepoint
0-2-4-6-8-10 Weeks
Method of measurement
Observation
Secondary outcomes
1
Description
Injection pain
Timepoint
0-2-4-6-8-10 weeks
Method of measurement
yes-no
2
Description
Recurrency
Timepoint
0-1-2-3-4-5-6 months
Method of measurement
yes-no
Intervention groups
1
Description
For the intervention group 0.1 mL intralesional MMR vaccine made by Razi institute will be injected
Category
Treatment - Drugs
2
Description
For the control group 0.3 mL intralesional normal saline will be injected.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Bualisina hospital of Sari
Full name of responsible person
Ghasem Rahmatpour Rokni
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
NO.2 Building of Mazandaran University of Medical Sciences, Moallem Square
City
Sari
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 of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ghasem Ramatpour Rokni, MD
Position
Dermatologist
Other areas of specialty/work
Street address
Bouali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3304 4804
Fax
Email
dr.rokni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ghasem Rahmatpour Rokni, MD
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Bualisina Hospital, Pasdaran Boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
dr.rokni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ozra Asghari Marzidareh
Position
General physician
Other areas of specialty/work
Street address
Bualisina Hospital, Pasdaran Boulevard, Sari
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
asqary19@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)