1- Objective: Comparison of the treatment's efficacy of micropunch grafting versus follicular grafting in the treatment resistance vitilig.
2- Design: Non randomized clinical trial, not blinded.
3- Setting & conduct: 25 patients suffering the treatment resistance vitiligo, aged 12-60 were selected. In one side of vitiligo lesions hair follicle graft were implemented. In the other side the vitiligo lesions, skin punch graft were done. The patients were visited after a week to evaluate the success of the transplant and possible side effects .Patients follow up were implemented up to 6 months. The repigmentatio's diameter were measured by ruler and recorded.
4- Participants: Inclusion criteria: Patients diagnosed as stabled (with no new lesions, or no progression of previous lesions during a recent year) treatment resistance vitiligo , not pregnant or breast feed and aged between 12 to 60 years.
Exclusion criteria: Patients diagnosed as non stable vitiligo ( with new lesions, or progression of previous lesions during a recent year ) , pregnant or breast feed , aged under 12 or over 60 years.
5- Intervention: Hair follicular graft and micropunch skin graft are administrating in each patient.
6- Main outcome measures variables: Measurement of repigmentation's degree.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122611806N1
Registration date:2013-01-04, 1391/10/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-04, 1391/10/15
Registrant information
Name
Moslem Safarpoor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 735 0513
Email address
safarpoor.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and Technology
Expected recruitment start date
2012-04-24, 1391/02/05
Expected recruitment end date
2012-10-26, 1391/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the treatment's efficacy of micropunch grafting versus follicular grafting in the treatment resistence vitiligo
Public title
Comparison of the treatment's efficacy of Skin grafting versus Hair grafting in the treatment resistence vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients diagnosed as stabled (with no new lesions or no progression of previous lesions during a recent year) treatment resistance vitiligo , not pregnant or breast feed and aged between 12 to 60 years.
Exclusion criteria: patients diagnosed as non stable vitiligo ( with new lesions or progression of previous lesions during a recent year ); pregnant or breast feed; aged under 12 or over 60 years.
Age
From 12 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not 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
Ahwaz Ethic Committee of Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
15794-61357
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
eth-436
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Repigmentation's degree
Timepoint
6 month
Method of measurement
Milimetre by ruler
Secondary outcomes
1
Description
Infection
Timepoint
1 weak after surgery
Method of measurement
Clinical
Intervention groups
1
Description
In one side of vitiligo lesions hair follicle graft were implemented .
Category
Treatment - Surgery
2
Description
In the other side the vitiligo lesions, skin punch graft were done
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Dermatology Center of Emam Khomeiny Hospital
Full name of responsible person
Moslem Safarpoor
Street address
Emam Khomeiny Hospital, Azadegan avenue
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and technology
Full name of responsible person
Dr Feghhi.Mostafa
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and technology
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
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Moslem Safarpoor
Position
MD, Dermatology Resident
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
dr.safarpoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Mapar
Position
MD, Dermatologist
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
Mapar@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Moslem Safarpoor
Position
MD, Dermatology Resident
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand avenue, Golestan bulvard
City
ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
dr.safarpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)