comparison of effect of PRP and Micro-needling with micro-needling alone in the treatment of Vitiligo
Design
A total 10 patients with vitiligo were enrolled for a prospective open pilot study
Settings and conduct
In this study 10 patients were chosen from the clinic of skin and stem cell research center of Tehran University of medical science being diagnosed with stable Non-segmental vitiligo for ages fifteen to sixty years old.
3 patches are selected from each individual .the first patches Micro-needling then PRP and second patches Micro-needling alone would be performed. The third patches is control .this procedure is repeated every two weeks for maximum 3 month in 6 sessions.in the end ,in order to evaluate the findings of this study the vitiligo European task factor (VETF) score ,Biometry ,Colorimetry and photography will be used to assess effectiveness of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with stable non segmental vitiligo,ages between 15 and 60
Exclusionary criteria: pregnancy, lactation, HIV infection, active vitiligo, infection in the recipient site, hepatitis, history of Keloid healing, history of Kobner phenomenon
Intervention groups
Patche number (1) Micro-needling then Intradermal PRP injection would be performed. . this procedur was repeated every 2 week for maximum 3 month(6 session)
patches number( 2 )Micro-needling alone would be performed. this procedur was repeated every 2 week for maximum 3 month(6 session)
patches number 3 was control.
Main outcome variables
Repgmentation of vitiligo patch
General information
Reason for update
Acronym
PRP(platelet Rich Plasma)
IRCT registration information
IRCT registration number:IRCT20160813029327N9
Registration date:2018-05-14, 1397/02/24
Registration timing:retrospective
Last update:2018-05-14, 1397/02/24
Update count:0
Registration date
2018-05-14, 1397/02/24
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effect of PRP and Micro-needling with micro-needling alone in the treatment of Vitiligo
Public title
Effect of Platelet Rich Plasma with Micro –needling in Regimentation of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with stable non segmental vitiligo
ages between 15 and 60
depigmented patches more than 2cm
Exclusion criteria:
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
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 Islamic Azad University of Pharmaciutical Science
Street address
Islamic Azad university of Pharmaciutical Science, Yakhchal Street, Shariati Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
6466_19395
Approval date
2017-01-05, 1395/10/16
Ethics committee reference number
IR.IAUREC.1395.44
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Disorders of pigmentation
Primary outcomes
1
Description
repigmentation
Timepoint
befor session 1 and one month after session six
Method of measurement
Biometry and calorimetry and photoraphy
Secondary outcomes
1
Description
Quality of life
Timepoint
Before of first session of treatment and one month after of last session
Method of measurement
Dermatology life quality index
Intervention groups
1
Description
Intervention group 1 : ) Micro-needling and intradermal PRP injection
Category
Treatment - Other
2
Description
Intervention group 2 : ) Micro-needling
Category
Treatment - Other
3
Description
Control group: there was no intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center Of Tehran University Of Medical Science
Full name of responsible person
Parvin Mansouri
Street address
No 4,Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
8164635597
Phone
+98 21 2220 1710
Email
mansouripr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Mansouri
Street address
No 4,Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
8164635597
Phone
+98 21 2220 1710
Email
mansouripr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Islamic Azad University
Full name of responsible person
Shaylan kalavi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad university of Pharmaciutical Science, Yakhchal Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
6466_19395
Phone
+98 21 2264 0056
Email
shaylan.k.sk@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Mansouri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4,Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
8164635597
Phone
+98 21 2220 1710
Email
mansouripr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rajabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Islamic Azad University Of Pharmaciutical Science, Yakhchal Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
6466_19395
Phone
+98 21 2264 0056
Email
Mehdirj@aol.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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