Objectives: To assess the effect of narrow band UVB with needling versus narrow band UVB alone on the treatment of vitiligo.
Design: A single blinded randomized clinical trial.
Setting and conduct: All eligible patients with vitiligo who will refer to clinic of Farshchian Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) age of older than of years; (b) having bilateral symmetrical vitiligo lesions on upper or lower limbs, face, or trunk; (c) the vitiligo is either stable or progressive; (d) at least 10% of the body surface is affected by the disease.
Exclusion criteria: (a) being immunodeficient; (b) being spontaneous repigmentation; (c) having any contraindications for phototherapy.
Intervention: Needling the margin of the vitiligo lesion toward the center once a week before phototherapy for three months plus phototherapy with NB-UVB once a week for three months.
Control: Phototherapy with NB-UVB alone once a week for three months
Primary outcome: Repigmentation of the lesion based on VASI criteria in the sixth and twelfth weeks.
Secondary outcome: Evaluation of probable superficial burn through clinical observation weekly before phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402169014N24
Registration date:2014-02-22, 1392/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-22, 1392/12/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of narrow band UVB with needling versus narrow band UVB alone on the treatment of vitiligo: a single blinded randomized clinical trial
Public title
Effect of narrow band UVB with needling versus narrow band UVB alone on the treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of older than of years; (b) having bilateral symmetrical vitiligo lesions on upper or lower limbs, face, or trunk; (c) the vitiligo is either stable or progressive; (d) at least 10% of the body surface is affected by the disease.
Exclusion criteria: (a) being immunodeficient; (b) being spontaneous repigmentation; (c) having any contraindications for phototherapy.
Age
From 7 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
29
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Two symmetrical lesions on either side of each patient are selected, one as intervention and the other as control. Thus, each patient will be compared with oneself.
Blinding: Photos will be taken from the lesions in the sixth and twelfth weeks. Then the photos will be evaluated and compared with each other by a physician who is not aware of the intervention. Thus, the study will be single blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
D/P/16/35/9/1115
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Repigmentation of the lesion
Timepoint
in the sixth and twelfth weeks
Method of measurement
based on VASI criteria
Secondary outcomes
1
Description
Evaluation of probable superficial burn
Timepoint
weekly before phototherapy
Method of measurement
through clinical observation
Intervention groups
1
Description
Needling the margin of the vitiligo lesion toward the center once a week before phototherapy for three months plus phototherapy with NB-UVB once a week for three months
Category
Treatment - Drugs
2
Description
Phototherapy with NB-UVB alone once a week for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Amaneh Yazdanfar
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Farshchian Hospital,
Full name of responsible person
Dr Mayam Rasouli Mohit
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
00
Fax
Email
rasouli27@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Amaneh Yazdanfar
Position
Dermatologist
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Postal code
Phone
+98 918 111 1070
Fax
Email
yazdanfar@usmsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)