In this clinical trial study, stable vitiligo patients that are resistant to other usual treatments and have a restricted involvement will be selected. We recommend to patients to discontinue all previous treatments one month before graft surgery. For performing graft, at first the recipient site cryotherapy with liquid nitrogen through two 10 second cycles and after blister induction its roof (epidermis) will be separated. The donor site after cleaning with povidon iodine and local anesthesia attaché to the vacuum device by injected lidocaine and after 2-3 hours the blister be ready and graft will be fixed in the recipient site with suture. Donor and recipient sites are dressed with antibiotic ointment and Vaseline gauze. For keep the site immobile after dressing, the recipient site will be performed under pressure bandage. We take photo from the lesion site before graft and at each visit (monthly until 6 months) for determining repigmentation rate. Finally repigmentation rate of graft site and their severity changes during follow up will be evaluated by comparison photos from patients and their statements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902143862N1
Registration date:2010-09-23, 1389/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-23, 1389/07/01
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2008-07-16, 1387/04/26
Expected recruitment end date
2011-03-17, 1389/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Suction Blister Epidermal Graft Efficacy in Treatment of Resistant Localized Vitiligo
Public title
Blister graft in Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years, Patients with stable vitiligo to usual treatments with restricted lesion that their size and form fix until 6 month. Also all treatments must be discontinued one month ago. Filling special consent form before surgery. Exclusion criteria: Patients with progressing disease, patients with diffuse widespread disease and not receive other treatments, Age below 18 years and cases that don’t filling consent form
Age
From 18 years old to 80 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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2008-07-10, 1387/04/20
Ethics committee reference number
87060
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
complete healing
Timepoint
weekly during first month then monthly untill 6 months
Method of measurement
recorded as photo from lesion site at each follow up visit
Secondary outcomes
1
Description
side effect
Timepoint
weekly during first month and then monthly untill 6 months
Method of measurement
recorded as photo from lesion site at each follow up visit
Intervention groups
1
Description
Epidermal graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Masoud Maleki, Dr Vahid Sanjari Ardabili
Street address
Daneshgah Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr Jalil Tavakoli Afshari
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Department of Dermatology, Ghaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Scinences, Biologist
Other areas of specialty/work
Street address
Research center of skin diseases and cutaneous leishmaniasis
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
hadis_yousefzadeh@yahoo.com , src@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology, Imam Reza Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Masoud Maleki, Dr Mahnaz Banihashemi
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Imam Reza Hospital, Mashad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1802 2510
Fax
Email
m_maleki@mums.ac.ir, banihashemim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dermatology Department, Ghaem Hospital, Mashhad University of Medical sciences
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences, Biologist
Other areas of specialty/work
Street address
Research center for skin disease and cutaneous leishmaniasis,office building, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
hadis_yousefzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)