Study of the efficacy of nano dressing in comparison common dressing after grafting of epidermal suspension containing melanocyte and keratinocyte in treatment of resistant vitiligo
Study of the efficacy of nano dressing in comparison common dressing after grafting of epidermal suspension containing melanocyte and keratinocyte in treatment of refractory vitiligo
Design
This study is a one-blinded clinical trial. The study population will be all patients referring to HajiDay Clinic in Kermanshah. 130 eligible patients will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
This study, which will be conducted at Taleghani Hospital of Kermanshah, is one-blind one that the researcher is unaware of the intervention method which is the type of dressing. After the intervention, the radiographs will be taken before and after the procedure and during the Follow-up Period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 11 and 60; Patients with vitiligo who have not been treated with corticosteroids or PUVA for at least 12 weeks; No active vitiligo; The absence of the Kubner phenomenon in the past
Exclusion criteria: Fertile and lactating women; Colloid history
Intervention groups
The intervention group will be dressed for one week with biodegradable and biodegradable nano dressing prepared by electrospinning. The control group will be dressed with conventional tetracycline ointment for one week
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N133
Registration date:2019-12-25, 1398/10/04
Registration timing:prospective
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
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
2020-01-10, 1398/10/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of nano dressing in comparison common dressing after grafting of epidermal suspension containing melanocyte and keratinocyte in treatment of resistant vitiligo
Public title
Study of the efficacy of nano dressing in comparison common dressing treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 11 and 60
Patients with vitiligo who have not been treated with corticosteroids or PUVA for at least 12 weeks
No active vitiligo
The absence of the Kubner phenomenon in the past
Exclusion criteria:
Fertile and lactating women
Colloid history
Age
From 11 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly by tossing coin
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is blinded to the intervention, which is a type of dressing and does not know which type of dressing will be used to treat them.
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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
ir.kums.rec.1398.674
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Wound healing
Timepoint
The first month is weekly and then monthly for up to 6 months
Method of measurement
Medical Imaging
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will be dressed for one week with biodegradable and biodegradable nano dressing prepared by electrospinning.
Category
Treatment - Drugs
2
Description
The control group will be dressed with conventional tetracycline ointment for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan, Haji Dai Clinic
Full name of responsible person
Hamid Eftekharipirouz
Street address
Golestan, Haji Dai Clinic
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 9054
Email
Hamideftekharipirous@gmail.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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
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
Hamid Eftekharipour
Position
Resident in Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Skin
Street address
Golestan, Haji Dai Clinic
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 9054
Email
Hamideftekharipirous@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ali Ebrahimi
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Beautiful skin and hair
Street address
Golestan, Haji Dai Clinic
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 9054
Email
aebrahimi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hamid Eftekharipirouz
Position
Resident in Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Skin
Street address
Golestan, Haji Dai Clinic
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 9054
Email
Hamideftekharipirous@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
2 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
Collected data is confidential and will not be shared with anyone else
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