This study is designed to compare the efficacy of basal cell layer suspension and topical calcipotriol with basal layer suspension in Treatment of Stable Vitiligo. 20 patients as groups of 10 subjects will be enrolled from the patients referred to dermatology clinic with a diagnosis of vitiligo. The main Inclusion criteria is : age (between 13 and 60 years), leukoderma type, stable vitiligo and lack of response to common treatment . The exclusion criteria is : patients with cardiovascular disorders ; patients older than 60 years and patients under 13 years old and patients with history of hypertrophic scar tissue and colloid. Skin samples taken from normal skin will be sent to laboratory for isolation of basal cell suspension. The suspension will be injected to the affected areas which will be dermabrasion formerly. In the second group, the calcipotriol cream will be used additionally. After recovery of the injection site in the second group, calcipotriol will be used once daily up to 6 months. The two groups will be compared in terms of pigmentation improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071418373N1
Registration date:2014-08-04, 1393/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Mohamad Reza Ranjkesh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 5061
Email address
ranjkeshm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Umbilical Cord Stem Cell Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Study of efficacy of basal cell layer suspension and topical calcipotriol with basal layer suspension in Treatment of Stable Vitiligo
Public title
Comparison Study of efficacy of skin pigment cell graft and topical calcipotriol cream with skin pigment cell graft in Treatment of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with 13 to 60 years old ; The number and size of lesions in at least two areas ; Leukoderma type ; stable vitiligo ; Lack of response to common treatment ; Consent to participate in the study.
Exclusion criteria: The patients who have responded well to the treatment ; Patients with cardiovascular disorders ; People aged over 60 years ; Pregnant and lactating women ; Patients under 13 years old ; Patient with history of Koebner phenomenon ; Patient with history of hypertrophic scar tissue and colloid ; The patients with unstable vitiligo.
Age
From 13 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
92228
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Pigmentation of skin with epidermal basal cell suspension grafting in the treatment of stable vitiligo
Timepoint
Baseline, after recovering of injection site and then monthly for 6 months
Method of measurement
Clinical observation
2
Description
Pigmentation of skin with epidermal basal cell suspension grafting and Calcipotriol in the treatment of stable vitiligo.
Timepoint
Baseline, after recovering of injection site and then monthly for 6 months
Method of measurement
Clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
In the first group :
Epidermal basal cell suspension will inject in the dermabrassioned affected areas of Vitiligo, then grafted area will dress up by a tour of silicon covered with a layer of woven gauze moistened with saline compressed and covered with semi-permeable Tegaderm film. The dressing is removed after 8 days. After 6 months, the amount and quality of depigmentation of grafted area will be studied and compared with second group. To determine the recovery rate serial images will produce monthly and repigmentation will express as percentage.
Category
Treatment - Other
2
Description
In the second group :1 to 3 weeks after basal cell suspensions transplantation when wound healing is comlete, Calcipotriol will be applied topically once a day for 6 months and then the quality of repigmentation will be discussed. To determine the recovery rate serial images will produce monthly and repigmentation will express as percentage
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Behzad Anosh
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Umbilical Cord Stem Cell Research Center of Tabriz University of Medical Sciences
Full name of responsible person
Samira Molayi
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Emam Reza hospital, Umbilical Cord Stem Cell Research Center (UCSRC) building.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Umbilical Cord Stem Cell Research Center of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Anosh
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave
City
Tabriz
Postal code
Phone
00
Fax
Email
behzadanosh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Reza Ranjkesh
Position
Dermatologist/Assistant professor
Other areas of specialty/work
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41154121013
Fax
Email
ranjkeshm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Izadseresht
Position
Medical Student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
b.izadseresht@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)