The aim of this treatment was to compare 2 methods of autologous cultured melanocytes transfer along with PUVA therapy with PUVA therapy alone in vitiligo treatment. 20 patients with vitiligo were randomly assigned to receive autologous cultured melanocytes transfer along with PUVA therapy or PUVA therapy alone. Re-pigmentation rate, time of re-pigmentation, and side effects were checked 3 weeks, 3 months, and 6 months after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706111159N1
Registration date:2010-09-07, 1389/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-07, 1389/06/16
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
Iran National Science Foundation
Expected recruitment start date
2007-08-30, 1386/06/08
Expected recruitment end date
2011-08-30, 1390/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of the efficacy of Autologus melanocyte transfer along with PUVA therapy and PUVA therapy alone in vitiligo patients
Public title
Comparative Evaluation of the efficacy of Autologus melanocyte transfer along with PUVA therapy and PUVA therapy alone in vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no treatment method since prior to 6 months ago, age 11-60, treatment history for 3 months
Exclusion criteria: pregnancy, breast feeding, depigmented patch >5 squared cm, active vitiligo, infection on treated site, cloid history, Cobner reaction
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jarib blv., Azadi sq., Isfahan
City
Isfahan
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
29033
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 rate
Timepoint
3 weeks, 3 months, 6 months after treatment
Method of measurement
perfect >90%, good 65-89%, moderate 25-64%, fair <25%
2
Description
side effects
Timepoint
3 weeks, 3 months, 6 months after treatment
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
autologous melanocyte culture along with puva therapy
Category
Treatment - Surgery
2
Description
puva therapy alone
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Disease and Leishmaniasis Research Center
Full name of responsible person
Mohammad Ali Nilforoushzadeh M.D
Street address
Third floor, Sedighe Tahereh building, Khorram st., Jomhoori sq., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr mahmood ahmadinejad
Street address
No 1, 5th street, Jalale al Ahmad cross, North Kargar Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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 Disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences,
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Third floor, Sedighe Tahereh building, Khorram st., Jomhoori sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
sdlrc@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin Disease and Leishmaniasis Research Center
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Third floor, Sedighe Tahereh building, Khorram st., Jomhoori sq., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
sdlrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)