Evaluation of the Effectiveness of Fractional CO2 Laser versus Dermabrasion for the Preparation of Lesion Site for Autologous Melanocyte and Keratinocyte Transplantation for Cell Therapy in Patients with stable Vitiligo: A Randomized pilot study
To Determine the effectiveness of Fractional CO2 Laser versus Dermabrasion for Preparation of Lesion Site for Autologous Melanocyte and Keratinocyte Transplantation for Cell Therapy in Patients with stable Vitiligo: A Randomized pilot study.
Design
This is a randomized pilot clinical trial done by the use of block permutation method. This study included 10 patients (male, female) aged between 18 and 50 years. The patients are divided into two groups of 5. The patients with persistent vitiligo whose disease stability is confirmed by the absence of new lesions over the last year based on the patients' medical history reports will participate in this study.
Settings and conduct
This is a randomized pilot clinical trial with block randomization method. This study is done in collaboration with Molecular Dermatology Research Center and Burn Research Center and performed at Burn Research Center, Amir-Al-Momenin Hospital, Shiraz University of Medical Sciences. In this study, 10 patients aged 18 to 50 years old will be randomly divided into two groups of 5 and will receive preparation method for cell transplantation either by fractional CO2 laser or by dermabrasion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with stable vitiligo whose disease stability on the basis of the absence of new lesions within the past one year has been reported by using the patient's past medical history. Exclusion criteria: Patients with more than 30% body surface involvement, pregnant women, patients with skin cancer and patients who receive other vitiligo treatments
Intervention groups
Intervention group1: preparation for cell transplantation by using fractional CO2 laser
Intervention group 2: preparation for cell transplantation by using dermabrasion method
Main outcome variables
Wound healing in patients with vitiligo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110731007160N8
Registration date:2020-08-16, 1399/05/26
Registration timing:prospective
Last update:2020-08-16, 1399/05/26
Update count:1
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Nasrin Hamidizadeh
Name of organization / entity
Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
hamidizade@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-01-26, 1399/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Fractional CO2 Laser versus Dermabrasion for the Preparation of Lesion Site for Autologous Melanocyte and Keratinocyte Transplantation for Cell Therapy in Patients with stable Vitiligo: A Randomized pilot study
Public title
Evaluation of the efficacy of fractional laser in comparison with dermabrasion for preparation of cell therapy in vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have stable vitiligo
Patients with stable vitiligo, whose disease stability has been proven in the last year and who have no new lesions based on a patient's reported medical history, will participate in the project
Exclusion criteria:
Patients with more than 30% body surface involvement, pregnant women, patients with skin cancer, and patients who receive other treatments for vitiligo are not included in the study.
pregnant women
patients with skin cancer and other vitiligo treatments
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a piloting-randomized pilot study using 2-block or 5-block blocks, in which 10 male or female patients are divided into two groups of 5 and randomly prepared by two methods of cell preparation. Therapies will be selected.
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 Shiraz University of Medical Sciences
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
shiraz
Province
Fars
Postal code
7134844119
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SUMS.REC.1399.127
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Melanin pigment production rate in skin
Timepoint
After 3 to 6 weeks of treatment
Method of measurement
Vitiligo Area Scoring Index (VASI)
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: The recipient area (max. 25 cm (30 min before beginning the procedure) is topically disinfected with chlorhexidine solution. Topical anesthesia is done using 2.5% Lidocaine and 2.5% Prilocaine topical cream,The recipient area is scratched with dermabrader device to reach the papillary dermis (spot bleeding) and the area is covered with a gauze. the cell sediment is placed in 1 ml of DMEMF / 12 and transferred to 1 ml syringe. A varying volume of solution is sprayed (0.1-0.5) and then the area is coverd with amniotic membrane.
Category
Treatment - Other
2
Description
Second group: The recipient area is disinfected with chlorhexidine solution and then anesthetized with 2.5% lidocaine cream - 2.5% prilocaine and then 4 cm2 area is lasered by using Fractional CO2 Laser (Microxel MX-7000, Wave length: 10,600, South Korea) with 20. Joules per second energy and five hundred micrometer spacing method, and a pre-prepared cell suspension is sprayed on the laser area, and the injected volume is between 0.5 and 0.1, depending on the size of the area being treated and then Is covered with amniotic membrane.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز تحقیقات مولکولی پوست، Burn and Wound Healing Research Center
Full name of responsible person
دکتر نسرین حمیدی زاده
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Fax
+98 71 3231 9049
Email
n.hamidizadeh.mdrc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Hamidizadeh
Position
Manager of Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizadeh.mdrc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Nasrin Hamidizadeh
Position
Manager of Research Center
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
n.hamidizadeh.mdrc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Ranjbar
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Others
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
s.ranjbar.mdrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic characteristics of the results of cell therapy in vitiligo patients
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Send researchers' requests via email and make a commitment to applicants to protect the data
From where data/document is obtainable
Sending researchers' requests via e-mail to the e-mail address of the executor and in charge of the project, Dr. Nasrin Hamidizadeh.
n.hamidizadeh.mdrc@gmail.com
What processes are involved for a request to access data/document
The applicant researcher should send his request to the email address of the executor of the project, Dr. Nasrin Hamidizadeh (n.hamidizadeh.mdrc@gmail.com). Within one week after evaluation, the data will be sent to the applicant via email, along with making a commitment.