Protocol summary

Summary
This is a randomized, double-blind, controlled clinical trial with placebo. The main objective is: determination of bulge and dermal papilla regimentation of the bonding and the outer root sheet of stable plaque. Criteria for inclusion: 1) At least 4 years have passed since the onset of their disease. 2) At least 6 months of stable disease and no new lesions. 3) The patient's lesions are bilateral. 4) There is not an appropriate response to other therapies. 5) There is no history of disease such as: hypothyroidism, hyperthyroidism, diabetes, asthma, atopic dermatitis, rhinitis, psoriasis, ulcerative colitis, lupus, alopecia areata, anemia pernicious. 6) Not currently being treated with other methods. Exclusion criteria: 1) pregnant women. 2) The incidence of these diseases 3) Parts of the bodies that are routinely exposed to light. 4) Patients who once responded to NBUVB return is after the break. 5) Kelloid. At first a small areas of the head selected, after anesthesia by lidocaine and epinephrine is then using a punch mm5 hair in the area occipital, removed and the bulge and outer root sheet dermal papilla may be extracted by suspension of the 3 is injected into the area provided below. Scheme used in this study, a block design capacity is 3 for each block. The patient in this study is considered a block and a third treatment is performed on each patient. Block designs, random allocation of treatments in each block must be done. Plaque in the first two of which will be created later Abryshn dermal needles are traumatized. A - The main area where melanocytes dermal papilla and outer Root sheet plus the Bulge area into the area. B - With the other, just insert a needle to create and respond to trauma is trauma. C - With the other, as seen in the control and the treatment will not be around either. Patients every month (up to 6 months) will follow-up. In each session, the size of the lesion on both sides will be measured and photographed and the response rates to treatment by a doctor who do not participate in the study based on the recovery rate subdivided from 95 to 100% = excellent, and 65 - 94% = Good, and 25 - 64% Fair = and 0 - 24% = Poor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203108567N1
Registration date: 2012-03-10, 1390/12/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Parviz Toossi
Name of organization / entity
Department of Dermatology, Skin Research Center Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
src@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of transplantation (non-cultured autologous melanocytes) bulge region , dermal papilla and outer root sheet in stable vitiligo plaques.
Public title
Effects of transplantation (non-cultured autologous melanocytes) in stable vitiligo plaques.
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion: 1) At least 4 years have passed since the onset of their disease. 2) at least 6 months of stable disease and no new leions. 3) The patient's lesions are bilateral.symetric 4) There is not an appropriate response to other therapies. 5) There is no history of disease. Such as hypothyroidism, hyperthyroidism, diabetes, asthma, atopic dermatitis, rhinitis, psoriasis, ulceritive colitis, lupus, alopecia areata, anemia Pernisious ... 6) not currently being treated with other methods. Exclusion criteria: 1) pregnant women. 2) The incidence of these diseases 3) parts of the body that are routinely exposed to light. 4) patients who once responded to NBUVB return is after the break. 5) kelloid
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Skin Research Center Ethics Committee
Street address
Shohada hospital, Shahrdari St.,Tajrish Sq.
City
Tehran
Postal code
198993414
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
م م ت941 -89

Health conditions studied

1

Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo

Primary outcomes

1

Description
Repigmentation
Timepoint
One month
Method of measurement
Size and photo

Secondary outcomes

1

Description
Side effect
Timepoint
During study
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: initially a small areas of the head selected by lidocaine with epinephrine anesthetic is then using a punch mm5 in the area occuipital removed and the bulge and outer root sheet and dermal papilla may be extracted by suspension of the procurement 3 is injected into the area.Scheme used in this study, a block design capacity is 3 for each block. The patient in this study, is considered a block and a third treatment is performed on each patient. Block designs, random allocation of treatments in each block must be done. Plaque in the first two of which will be created later dermal abration with needle are traumatized. a - The main area where melanocytes Dermal papilla and outer Root sheet plus the Bulge area into the area.
Category
Treatment - Surgery

2

Description
C - with the other, as seen in the control and the treatment will not be around either.
Category
N/A

3

Description
B - with the other, just insert a needle to create traumaand respond to trauma
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish & Loghman hospitals
Full name of responsible person
Dr. Shakoei
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossien Goodarzi
Street address
Chamran HighwaySt. Evin Taleghani Hospital Medical School, 3rd Floor
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, Shahid Beheshti 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
Dermatology Research Center
Full name of responsible person
Dr. Shakoei
Position
MD, Dermatology Resident
Other areas of specialty/work
Street address
Shohada hospital shahrdari St. Tajrish Sq.
City
Tehran
Postal code
198993414
Phone
+98 21 2274 1507
Fax
+98 21 2274 4393
Email
dr.shakoei@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dermatology Research Center
Full name of responsible person
Dr.Toosi
Position
Professor
Other areas of specialty/work
Street address
Shohada hospital shahrdari St. Tajrish Sq.
City
Tehran
Postal code
198993414
Phone
+98 21 2274 1507
Fax
+98 21 2274 4393
Email
src@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dermatology Research Center
Full name of responsible person
Dr. Ali Abbasi
Position
Dermatologist
Other areas of specialty/work
Street address
Shohada hospital
City
Tehran
Postal code
198993414
Phone
+98 21 8888 6700
Fax
Email
draliabbasi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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