The purpose of the study is the comparison of PRP and hair transplantation with hair transplantation alone in the treatment of vitiligo. In this study 22 patients from the clinic of Dr.Feily would be selected. After fulfill the consent form patients undergo the hair transplantation in some lesions in both sides of the body.Inclusion criteria : Patients diagnosed with stable, refractory vitiligo ages below 12 or above 60 years. Several lesions would be selected in both sides of the body symmetrically then hair transplantation by FIT method would be performed. After 5 days dressing would be removed and PRP would be perform on both hair transplanted and non hair transplanted lesions on one side of the body randomly . After 2 days NBUVB would be started for both sides of the body. Every months until 3 months peri-follicular pigmentation would be measure with caliper. In non transplanted lesions VETI score would be calculate. After 3 months we compare the result of both sides of the body. Ultimately in would be clear that whether PRP increases the peri-follicular pigmentation or it does not have therapeutic efficacy.
General information
Acronym
PRP: platelet-rich plasma
IRCT registration information
IRCT registration number:IRCT2015120725407N1
Registration date:2016-01-29, 1394/11/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-29, 1394/11/09
Registrant information
Name
Amir Feily
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 715234665
Email address
dr.feily@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Expected recruitment start date
2015-12-21, 1394/09/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of PRP and hair transplantation with hair transplantation alone in the treatment of vitiligo
Public title
Effect of PRP on the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patients diagnosed with stable; refractory vitiligo; No treatment in the last 6 months; depigmented patch more than 5 cm; ages between 12 and 60 years old.
Exclusionary criteria included : pregnancy; lactation; hepatitis; HIV infection; active vitiligo; infection in the recipient site; history of photosensitivity or skin cancer; history of keloid healing; history of Kobner phenomenon.
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-11-17, 1394/08/26
Ethics committee reference number
IR.TUMS.REC.1394.1186
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
perifollicular repigmentation after treatment
Timepoint
1 month, 2 months, 3 months after treatment
Method of measurement
Caliper, VETTI score
Secondary outcomes
empty
Intervention groups
1
Description
follicular grafts would be transplanted With FIT technique throughout some lesions. After 5 days dressings would be removed and PRP would be injected on hair transplanted and non hair transplanted lesions. Two days later the entire lesions would exposed to phototherapy twice a week for three months; the dose would be increased 15% at each treatment interval
Category
Treatment - Surgery
2
Description
In the lesions of the other site of the body follicular grafts would be transplanted With FIT technique throughout the lesions. After 5 days dressings would removed. Two days later the lesional skin was exposed to phototherapy twice a week for three months; the dose increased 15% at each treatment interval
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Feily Clinic of Dermatology and Hair Transplantation
Full name of responsible person
Amir Feily
Street address
Dr.Feily Clinic of Dermatology and Hair Transplantation. Moalem BLVD, Jahrom, Iran
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Skin and Stem cell Research Center of Tehran University of Medical S
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Grant name
مستقل
Grant code / Reference number
123700016
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Skin and Stem cell Research Center of Tehran University of Medical S
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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amir Feily
Position
Dermatologist
Other areas of specialty/work
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
dr.feily@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amir Feily
Position
DErmatologyst
Other areas of specialty/work
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
dr.feily@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amir Feily
Position
Dermatologist
Other areas of specialty/work
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
dr.feily@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)