The effect of biodegradable polymeric electrospun nanofiber as the biological dressing for vitiligo treatment
Design
This study is a nonblinded clinical trial. The research population will be included of all patients referring to private skin clinic in Kermanshah city.20 eligible patients will be selected conveniently and Non-random assigned to intervention and control groups.
Settings and conduct
This study is a non-blind non randomizes clinical trial which will be conducted at a personal office of a Dermatologist in Kermanshah. At the beginning of the study, the color and approximate size of the skin lesions are evaluated and recorded in a checklist and will be re-examined after the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unstable vitiligo
Exclusion criteria: Pregnancy; lactation; other systemic diseases such as cardiovascular disease; Renal or liver failure.
Intervention groups
In the intervention group, nano-bandages (Polyvinyl alcohol, Merck Germany) will be used on vitiligo skin lesion for one week to ten days. Dressing will not be changed, it will only be checked for infection every two days.
In the control group for a week to ten days, the usual dressing (Cellulose) will be used on the lesion. Dressing will not be changed, it will only be checked for infection every two days.
Main outcome variables
Skin lesion size، Change in the color of skin lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N98
Registration date:2018-08-16, 1397/05/25
Registration timing:registered_while_recruiting
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2019-01-15, 1397/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nano bandage and cellulose bandage on the size of the skin lesion in patients with Vitiligo
Public title
The effect of nano bandage for vitiligo treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unstable vitiligo
Exclusion criteria:
Pregnancy and lactation
Other systemic diseases such as cardiovascular disease
Renal or liver failure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not 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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-07-05, 1396/04/14
Ethics committee reference number
ir.kums.rec.1396.176
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
The skin lesion size
Timepoint
At the beginning of the study, ten days and six months after the end of the study
Method of measurement
Using the digimizer software
2
Description
Change in the color of skin lesions
Timepoint
At the beginning of the study, ten days and six months after the end of the study
Method of measurement
Using the digimizer software
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, nano-bandages(Polyvinyl alcohol, Merck Germany) will be used for one week to ten days. The dressing will not be changed, it will only be checked for infection every two days once
Category
Treatment - Other
2
Description
In the control group the usual dressing (Cellulose) will be used for a week to ten days. The dressing will not be changed, it will only be checked for infection every two days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Sara Kahrarian
Street address
Golestan Square
City
Kermanshah
Province
Kermanshah
Postal code
6715813142
Phone
+98 83 3427 6482
Email
kahrariansara@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sarar Kahrarian
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar blvd
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6489
Email
kahrariansara@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Elham Arkan
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Faculty of Pharmacy, Parastar blvd
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6489
Email
earkan@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Kahrarian
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Parastar blvd
City
Kermanshah
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6489
Email
kahrariansara@yahoo.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
If the data in this study is necessary for another study
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail