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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	IRCT
Last refreshed on:	22 February 2018
Main ID:	IRCT138904081159N6
Date of registration:	2013-08-25
Prospective Registration:	No
Primary sponsor:	Vice chancellor for research, Tehran University of Medical Sciences
Public title:	Comparative evaluation of efficacy of multiple treatments in the treatment of vitiligo
Scientific title:	Comparative evaluation of efficacy of dermabrasion alone, injection of melanocyte suspension and autologous melanocyte suspension transfer in the treatment of vitiligo
Date of first enrolment:	2012-06-21
Target sample size:	70
Recruitment status:	Complete
URL:	http://en.irct.ir/trial/266
Study type:	interventional
Study design:	Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
Phase:	3

Countries of recruitment
Iran (Islamic Republic of)

Contacts

Name:	Fariba Jaffary
Address:	Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran Isfahan Iran (Islamic Republic of)
Telephone:	+98 31 1337 3736
Email:	jaffary@pharm.mui.ac.ir
Affiliation:	Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir

Name:	Fariba Jaffary
Address:	Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran Isfahan Iran (Islamic Republic of)
Telephone:	+98 31 1337 3736
Email:	jaffary@pharm.mui.ac.ir
Affiliation:	Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, I

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria:
1- Having no treatment within past 6 months
2- Men or women of 11-60 years old
3- Have a diagnosis of vitiligo with depigmented patch more than 5 cm despite receiving at least 3 months active treatment
4- Stable vitiligo for at least 1 year
5- No infection at recipient site
6- No history of keloid and or koebner phenomenon
7- No history of active hepatitis the B, C, or AIDS
8- No pregnancy or breast-feeding
9- No active uncontrolled chronic systemic disease
Exclusion Criteria:
Vitiligo patients with active or progressive disease within last 12 months.
Exclusion criteria:

Age minimum: 11 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

vitiligo.
disorder of pigmentation

disorder of pigmentation

Intervention(s)

Intervention 1: Dermabrasion alone: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch. Intervention 2: Combined dermabrasion and melanocyte suspension in media: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc cell suspension in patient serum with replacement of patient serum with any dilution at the end of cell suspension preparation. Intervention 3: Injection of melanocyte suspension (only in phosphate-buffered saline (PBS)): One time 0.4 cc sub cutis injection of melanocyte suspension in phosphate-buffered saline with tenfold dilution. Intervention 4: Combined dermabrasion and melanocyte suspension in PBS: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc melanocyte suspension in phosphate-buffered saline with tenfold dilution.

Combined dermabrasion and melanocyte suspension in media: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc cell suspension in patient serum with replacement of patient serum with any dilution at the end of cell suspension preparation

Combined dermabrasion and melanocyte suspension in PBS: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch and 1 time transfer of 0.4 cc melanocyte suspension in phosphate-buffered saline with tenfold dilution

Dermabrasion alone: One time dermabrasion with cone shape head of high speed mini craft dermabrader until appearance of pinpoint bleeding in depigmented patch

Injection of melanocyte suspension (only in phosphate-buffered saline (PBS)): One time 0.4 cc sub cutis injection of melanocyte suspension in phosphate-buffered saline with tenfold dilution

Primary Outcome(s)

Pigmentation. Timepoint: Before intervention and 1 week, 3 weeks, 1 month and 3 months after transplantation. Method of measurement: Observation, wood lamp, visioface software.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Vice chancellor for research, Tehran University of Medical Sciences

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Tehran University of Medical Sciences

Results

Results available:
Date Posted:
Date Completed:
URL:

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