Autologous melanocyte – keratinocyte suspension transplantation in patients with postburn leukoderma
Comparison of two techniques to prepare the recipient site: Dermabrasion Versus Erbium: YAG laser
Objectives: Autologous melanocyte – keratinocyte suspension transplantation in patients with postburn leukoderma
Comparison of two techniques to prepare the recipient site: Dermabrasion Versus Erbium: YAG laser. Design: Randomized, Not blinded, Clinical trial. Setting and Conduct: In this study, patients were randomly divided into two groups A and B. Group A patients after skin biopsy as a donor site, in vitro melanocyte suspensions are prepared in accordance with patent procedures. The suspension obtained is transmitted to the desired area via dermabrassion technique. Group B patients receive suspension with Erbium YAG laser technique. From the third week UVA phototherapy is administered weekly for 3 months. Outcom measures will be assessed by the use of serial photography at baseline, one, three and six months after intervention. The study population: Post- burn leukoderma patients. Inclusion criteria: Age ≥18 years; without history of chronic diseases; The absence of coagulopathy; No evidence of hypertrophic burn scar; The total area treated is >40 cm2. Exclusion criteria: Previous treatment of skin lesions; Active systemic infection. Intervention: One arm receives suspension via dermabrasion technique and the other receives suspension via Erbium YAG laser. Main Outcome Measures: Repigmentation scales assessed by dermatology Colleagues blinded to the randomization process and by means of serial photography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016013026269N1
Registration date:2016-03-23, 1395/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Marzieh Matin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5244 5288
Email address
marziehmatin@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Ethics committee of Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous melanocyte – keratinocyte suspension transplantation in patients with postburn leukoderma
Comparison of two techniques to prepare the recipient site: Dermabrasion Versus Erbium: YAG laser
Public title
efficacy of skin pigment suspension in treatment of white burn scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age ≥18 years; Non-pregnant and non-breast feeding women; without history of chronic diseases, skin cancer, drug sensitivity/sever allergic reactions, immun deficient, organ transplant or steroid treatment; The absence of coagulopathy or anticoagulation therapy; No evidence of hypertrophic burn scar; The total area treated is >40 cm2. Exclusion criteria: Previous treatment of skin lesions; Active systemic infection.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ethic committee of Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.MUI.REC.1394.3.304
Health conditions studied
1
Description of health condition studied
post-burn leukoderma
ICD-10 code
L81.5
ICD-10 code description
Leukoderma, not elsewhere classified
Primary outcomes
1
Description
repigmentation scales
Timepoint
one, three and six months after the end of treatment
Method of measurement
by dermatology Colleagues blinded to the randomization
Secondary outcomes
1
Description
Edema, Erythema, Infection and Dyspigmentation
Timepoint
One week, ane month, three months and six months after treatment
Method of measurement
Eye Clinical Evaluation
Intervention groups
1
Description
After preparing melanocyte suspension according to patent No.139250140003003854, dermabrasion performed by high- speed motor dermabrador and Suspension will be transferred to the desired location. It is then covered by a mepitel bandage. Patients treated with oral antibiotics for a week (Cephalexin 500 mg Q6h). In the first follow-up a week later removed the bandage. From the third week UVA phototherapy is administered weekly for 3 months.
Category
Treatment - Devices
2
Description
After preparing melanocyte suspension according to patent No.139250140003003854, Suspension by Erbium YAG laser( lotus II, laseropteck compay, Seoul, Korea, 2012) with wave length 2940 nm, spot size 3 mm, pulse energy 1200 mj and 2 laser passes will be transferred to the desired location. It is then covered by a mepitel bandage. Patients treated with oral antibiotics for a week (Cephalexin 500 mg Q6h). In the first follow-up a week later removed the bandage. From the third week UVA phototherapy is administered weekly for 3 months.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Marzieh Matin
Street address
Al Zahra Hospital, Soffeh Blvd, Isfahan.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences.
Full name of responsible person
Dr Mansur Siavash
Street address
Deputy of Research of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
394304
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan 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 disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Marzieh Matin
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd.
City
Isfahan
Postal code
Phone
+98 31 3339 0100
Fax
+98 31 3628 9194
Email
marziehmatin@resident.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Fariba Jafari
Position
Associate Professor
Other areas of specialty/work
Street address
Skin disease and Leishmaniasis Research Center, Khoram Avenue, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 3337 3736
Fax
Email
jaffary@pharm.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Marzieh Matin
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd.
City
Isfahan
Postal code
Phone
+98 31 3339 0100
Fax
Email
marziehmatin@resident.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)