Effect of narrow band UVB in combination with 0.1% topical Tacrolimus versus narrow band UVB alone on treatment of patients with vitiligo: a double blind randomized clinical trial
Objectives: To assess the effect of narrow band UVB in combination with 0.1% topical Tacrolimus versus narrow band UVB alone on treatment of vitiligo.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible patients with vitiligo who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: presence of bilateral symmetrical vitiligo lesions on upper and lower limbs, face or trunk; fixed or progressive disease process; involvement of at least 10 percent body surface.
Exclusion criteria: using topical treatments in the past one month; immunodeficiency; any contraindication of phototherapy.
Intervention group: narrow band UVB at a dose of 0.5 to 1 j/cm2 plus 0.1% Tacrolimus topical ointment twice a day for 3 months.
Control group: narrow band UVB at a dose of 0.5 to 1 j/cm2 plus Eucerin (placebo) topical ointment twice a day for 3 months.
Primary outcome: Measuring vitiligo score using VASI scoring scale before intervention and 1.5 and 3 months after intervention.
Secondary outcome: Assessing local adverse events (erythema and inflammation) 1.5 and 3 months after intervention through physical examination.
Randomization: Each patients will be his/her own control. For this purpose, the lesions of one side of the body will be randomly treated with combination therapy and the other side will be treated with placebo.
Blinding: Patients will be unaware of the type of topical ointment. The physician who will examine the lesions will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606239014N103
Registration date:2016-07-01, 1395/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
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
2016-07-10, 1395/04/20
Expected recruitment end date
2017-07-11, 1396/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of narrow band UVB in combination with 0.1% topical Tacrolimus versus narrow band UVB alone on treatment of patients with vitiligo: a double blind randomized clinical trial
Public title
Effect of narrow band UVB in combination with 0.1% topical Tacrolimus versus narrow band UVB alone on treatment of patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of bilateral symmetrical vitiligo lesions on upper and lower limbs, face or trunk; fixed or progressive disease process; involvement of at least 10 percent body surface.
Exclusion criteria: using topical treatments in the past one month; immunodeficiency; any contraindication of phototherapy.
Age
No age limit
Gender
Both
Phase
2
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Each patients will be his/her own control. For this purpose, the lesions of one side of the body will be randomly treated with combination therapy and the other side will be treated with placebo.
Blinding: Patients will be unaware of the type of topical ointment. The physician who will examine the lesions will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
IR.UMSHA.REC.1395.72
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Measuring vitiligo score
Timepoint
before intervention and 1.5 and 3 months after intervention
Method of measurement
using VASI scoring scale
Secondary outcomes
1
Description
Assessing local adverse events (erythema and inflammation)
Timepoint
1.5 and 3 months after intervention
Method of measurement
through physical examination
Intervention groups
1
Description
narrow band UVB at a dose of 0.5 to 1 j/cm2 plus 0.1% Tacrolimus topical ointment twice a day for 3 months
Category
Treatment - Drugs
2
Description
narrow band UVB at a dose of 0.5 to 1 j/cm2 plus Eucerin (placebo) topical ointment twice a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Bahareh Ebrahimi
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 Bahareh Ebrahimi
Position
Resident of Dermatology
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
dr_ebrahimi_b@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 81 3827 4184
Fax
Email
amyazdanfar2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)