To compare the effect of NB-UVB with and without topical Latanoprost solution or placebo in Vitiligo Patients
Design
This is a triple-blind randomized clinical trial, phase II, in which 30 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with Vitiligo who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be triple-blinded so that neither patients nor the physician who will examine the patients and data analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 12 to 70 years
Vitiligo lesions with at least one lesions on each side
Involving at least 20% of the body surface
Exclusion criteria:
Malignant skin disease
Failure of the previous radiotherapy
Pregnancy or breastfeeding
Hepatic or renal disease
Lupus Erythematosus
Photosensitivity
Intervention groups
Intervention group:
NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a Latanoprost solution 0.005% twice a day for three consecutive months
Control group:
NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a normal saline solution twice a day for three consecutive months
Main outcome variables
Improvement of Vitiligo lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N283
Registration date:2019-05-29, 1398/03/08
Registration timing:prospective
Last update:2019-05-29, 1398/03/08
Update count:0
Registration date
2019-05-29, 1398/03/08
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
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of NB-UVB with and without topical Latanoprost solution or placebo in Vitiligo Patients: a triple-blind clinical trial study
Public title
Comparison of effect of NB-UVB with and without topical Latanoprost solution or placebo in Vitiligo Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 12 to 70 years
Vitiligo lesions with at least one lesions on each sides
Involving at least 20% of the body surface
Exclusion criteria:
Malignant skin disease
Failure of previous radiotherapy
Pregnancy or breastfeeding
Hepatic or renal disease
Lupus Erythematosus
Photosensitivity
Age
From 12 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple blind.
Placebo
Used
Assignment
Parallel
Other design features
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 and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-05-18, 1397/02/28
Ethics committee reference number
IR.UMSHA.REC.1398.165
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Improvement of Vitiligo lesions
Timepoint
3 months after the intervention
Method of measurement
With physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a Latanoprost solution 0.005% twice a day for three consecutive months
Category
Treatment - Drugs
2
Description
Control group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a normal saline solution twice a day for three consecutive months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Dr Hanieh Karimi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
haniehkarimi67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hanieh Karimi
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
haniehkarimi67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Pedram Alirezaei
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
prc@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available