To assess the efficacy of autologous, non-cultured and non-trypsinized melanocyte transplantation in treatment of stable vitiligo
Design
This phase 3 study is performed in 93 vitiligenous lesions at single center in vitiligo patients who refer to single center of Haj daie dermatology clinic in Kermanshah city. Information about this procedure is given to the patients and after obtaining consent enroll in study.
Settings and conduct
Vitiligo is a common dermatology disorder that usually unresponsive to medical therapy and associated with unpleasant appearance, familial problems and neuro-psychiatric disorder.The donor site containing normal pigmentation such as buttock and thigh area is selected. After local anesthesia, firstly the epidermis is shaved using a curretage number 2 until point bleeding appears as a marker of the epidermis and dermis junction, later he harvested material is mixed with some hyaluronic acid gel in a sterile container and finally this suspension transplanted in recipient denuded sites. This site is dressed with semi-permeable dressing.
The patient is evaluated at the first and third week and then monthly. The rate of re-pigmentation and possible complications are recorded.
Participants/Inclusion and exclusion criteria
Patients who clinically confirmed stable vitiligo are subjected to treatment.Pregnant and breast feeding women, patients with cardio-vascular and repair disorder, unstable and universal vitiligo rule out from study.
Intervention groups
Because of absence of melanocyte reservoir in vitiligenous lesions most of vitiligo unresponsive to ordinary treatment and phototherapy. Autologous, non-cultured and non-trypsinized melanocyte transplantation is a safe and less aggressive procedure that can be a appropriate method for treatment of refractory vitiligo.
Main outcome variables
The rate of re-pigmentation in treated area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110507006403N9
Registration date:2020-03-16, 1398/12/26
Registration timing:registered_while_recruiting
Last update:2020-03-16, 1398/12/26
Update count:0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1837 5424
Email address
hkawosi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of autologous non-cultured and non-trypsinised melanocytes and keratinocytes grafting in treatment of refractory vitiligo
Public title
Efficacy of autologous and non-processed melanocyte grafting in treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically documented vitiligenous lesions
Exclusion criteria:
Unstable vitiligo
Pregnancy
Breast feeding
Generalized vitiligo
Patients recently subject to phototherapy and drugs used for vitiligo
Cardio-vascular patients
Patients with repair disorder
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:
20
More than 1 sample in each individual
Number of samples in each individual:
5
Patients usually have more than one lesion.
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 Kermanshah University of Medical Sciences
Street address
hajdaei clinic
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.KUMS.REC.1398.975
2
Ethics committee
Name of ethics committee
ethicts committee of medical univercity of kermanshah
Street address
mostafa emami
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
ir.kums.rec.1398.975
3
Ethics committee
Name of ethics committee
ethics committee of kermanshah univercity medical science
Street address
mostafa emami Ave., kermanshah city,
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.KUMS.REC.1398.975
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Re-pigmentation
Timepoint
The first and third week and then every month for up to 4 months
Method of measurement
Area measurement with software
Secondary outcomes
empty
Intervention groups
1
Description
The epidermis is shaved from the lower limb as donor site, which has normal pigment with a disposable and sharp curettage device. The harvested materials is mixed with hyaluronic acid gel. The vitiligo skin patches as recipient site, also is shaved with curettage. Later the harvested suspension is transplanted in the recipient site. The patient is evaluated at the first and third week and then monthly.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj daie dermatology clinic
Full name of responsible person
Hossein Kavoussi
Street address
No.1, Haj daie clinic, Golestan Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714647934
Phone
+98 83 3845 3486
Email
hkawosi@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
No 2 bulding, Shahid Beheshty Blvd
City
Kermanshqah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 0541
Email
farid_n32@yahoo.com
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
Fatemeh Ahmad Aghaei
Position
Dermatology residency
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.1, Haj daie dermatology clinic, Golestan Blvds
City
Kermanshah
Province
Kermanshah
Postal code
6714647934
Phone
+98 83 3845 3486
Email
fatemehahmadaghaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 1, Haj daie dermatology clinic, Golestan Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714647934
Phone
+98 83 3845 3486
Email
Ebrahimider@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Kavoussi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 1, Haj daie drmatology clinic, Golestan Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714647934
Phone
+98 83 3845 3486
Email
reza.kavoussi73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD