Comparative evaluation of efficacy of dermabrasion alone, injection of melanocyte suspension and autologous melanocyte suspension transfer in the treatment of vitiligo
This study is a randomized clinical trial that its aim is to compare 4 methods of dermabrasion alone, injection of melanocyte suspension (only in Phosphate-buffered saline (PBS)), and combined dermabrasion and melanocyte suspension in PBS or media for the treatment of patients with stable vitiligo.
Seventy patients with vitiligo will be enrolled. Inclusion Criteria: Having no treatment within past 6 months and men or women of 11-60 years old. Exclusion Criteria: Vitiligo patients with active or progressive disease within last 12 months.
Randomization is done using random number table. In each patient 4 eligible patches will be randomly allocated in 4 above treatment groups (each patch in one group). After skin biopsy from donor site, cell suspension will be prepared in two forms of phosphate-buffered saline (PBS) and patient serum for transfer or injection in recipient site. In recipient site, dermabrasion alone with high-speed dermabrader is used until appearance of the dermo-epidermal junction and pinpoint bleeding. This area is covered with saline soaked gauze, or dermabrasion is done along with the transfer of cell suspension in the base of phosphate-buffered saline (PBS) and patient serum. In injection method, cell suspension is prepared in phosphate-buffered saline (PBS) and is injected in sub cutis area. The improvement rate will be assessed based on percent of repigmentation. Follow up visits will be done during 3 weeks, and 1 and 3 months after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904081159N6
Registration date:2013-08-25, 1392/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-25, 1392/06/03
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of efficacy of dermabrasion alone, injection of melanocyte suspension and autologous melanocyte suspension transfer in the treatment of vitiligo
Public title
Comparative evaluation of efficacy of multiple treatments in the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1- Having no treatment within past 6 months
2- Men or women of 11-60 years old
3- Have a diagnosis of vitiligo with depigmented patch more than 5 cm despite receiving at least 3 months active treatment
4- Stable vitiligo for at least 1 year
5- No infection at recipient site
6- No history of keloid and or koebner phenomenon
7- No history of active hepatitis the B, C, or AIDS
8- No pregnancy or breast-feeding
9- No active uncontrolled chronic systemic disease
Exclusion Criteria:
Vitiligo patients with active or progressive disease within last 12 months.
Age
From 11 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
57393
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
disorder of pigmentation
Primary outcomes
1
Description
Pigmentation
Timepoint
Before intervention and 1 week, 3 weeks, 1 month and 3 months after transplantation
Method of measurement
Observation, wood lamp, visioface software
Secondary outcomes
empty
Intervention groups
1
Description
Dermabrasion alone: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch
Category
Other
2
Description
Combined dermabrasion and melanocyte suspension in media: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc cell suspension in patient serum with replacement of patient serum with any dilution at the end of cell suspension preparation
Category
Other
3
Description
Injection of melanocyte suspension (only in phosphate-buffered saline (PBS)): One time 0.4 cc sub cutis injection of melanocyte suspension in phosphate-buffered saline with tenfold dilution
Category
Other
4
Description
Combined dermabrasion and melanocyte suspension in PBS: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc melanocyte suspension in phosphate-buffered saline with tenfold dilution
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Fariba Jaffary
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Fariba Jaffary
Position
Associate professor
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
jaffary@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Fariba Jaffary
Position
Associate professor
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
jaffary@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)