Protocol summary

Summary
Introduction: Vitiligo is a common disease that Depigmented macules appear on skin. Etiology of disease is unknown. There are many different treatment options available for patients. The purpose of this study was assessment of the efficacy of hair follicle autograft in treatment of segmental vitiligo. Mothods: in this clinical trial study we transplanted pigmented hair follicle on segmental vitiligo patches, unresponsive to other treatment and the extent of response to treatment was evaluated. 10 patients who were suffering from segmental vitiligo were choosen for this study. Some 5mm punch autografts were harvested from occipital area for scalp and they were trimmed and divided into micrografts as one follicle and then inserted in depigmented area

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812183310N1
Registration date: 2010-05-18, 1389/02/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-18, 1389/02/28
Registrant information
Name
Babak Jafari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 88672298
Email address
babakjafari@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2007-10-10, 1386/07/18
Expected recruitment end date
2008-05-15, 1387/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of segmental vitiligo with normal Hair follicle Autograft.
Public title
Vitiligo and Hair Autograft
Purpose
Treatment
Inclusion/Exclusion criteria
Segmental vitiligo patients with no response to other treatment
Age
From 21 years old to 43 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Medical Faculty of Iran University of Medical Sciences
Street address
Hemmat Exp way, Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2008-07-10, 1387/04/20
Ethics committee reference number
20080710

Health conditions studied

1

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

Primary outcomes

1

Description
Appearance of spots of Repigmentation
Timepoint
after 4, 8 and 12 weeks
Method of measurement
Observing the size and shape

Secondary outcomes

empty

Intervention groups

1

Description
One or two 5mm punch autografts will be harvested from occipital area of scalp. They will be trimmed and divided into micrografts as one follicle and inserted in depigmented area
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology Department, Hazrat Rasool Hospital
Full name of responsible person
Babak Jafari
Street address
Niayesh St, Sattar khan St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mir hadi Aziz Jalali
Street address
Dermatology Department, Niayesh St, Sattar khan St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Babak Jafari
Position
MD
Other areas of specialty/work
Street address
Niayesh St, Sattar khan St
City
Tehran
Postal code
Phone
+98 912 699 5956
Fax
Email
babakjafari@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mir Hadi Aziz Jalali
Position
MD
Other areas of specialty/work
Street address
Niayesh st, Sattarkhan st
City
Tehran
Postal code
Phone
+98 912 699 5956
Fax
Email
babakjafari@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mir Hadi Aziz Jalali
Position
MD
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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