A comparative study on the therapeutic effect of combined NBUVB (Narrow Band Ultraviolet B) and systemic Simvastatin with NBUVB alone in patients with vitiligo
The effect of phototherapy and oral Simvastatin in comparison with phototherapy alone in the treatment of patients with vitiligo
Design
This study is a phase 3 randomized, double-blind, randomized clinical trial. A total of 50 patients will be selected from the dermatology clinic of Shahid Faghihi Hospital in Shiraz. Sample size is determined using NCSS software, 90% power and first type error 5% and using the same previous article. The studied patients are randomly divided into two groups of intervention and control through block randomization. Statistical methods of analysis are the results of independent t-test - Chi-square test.
Settings and conduct
Shahid Faghihi Clinic, Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients with vitiligo who have just started treatment and have not taken medication in the last 6 months.
Intervention groups
Simvastatin 20 mg drug made by Iranian company Poursina (first month 2 times a day in the second month 3 times a day in the third and fourth month 4 times a day) And placebo (made by Shiraz School of Pharmacy) similar to Simvastatin.
Main outcome variables
-Lesion healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045092N2
Registration date:2021-01-01, 1399/10/12
Registration timing:retrospective
Last update:2021-01-01, 1399/10/12
Update count:0
Registration date
2021-01-01, 1399/10/12
Registrant information
Name
Ladan Dastgheib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9049
Email address
dastghl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-10-16, 1394/07/24
Expected recruitment end date
2016-03-13, 1394/12/23
Actual recruitment start date
2015-10-16, 1394/07/24
Actual recruitment end date
2016-03-13, 1394/12/23
Trial completion date
2016-03-13, 1394/12/23
Scientific title
A comparative study on the therapeutic effect of combined NBUVB (Narrow Band Ultraviolet B) and systemic Simvastatin with NBUVB alone in patients with vitiligo
Public title
A comparative study on the therapeutic effect of combined NBUVB and systemic Simvastatin with NBUVB alone in patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have just started treatment and have not taken medication in the last 6 months
Exclusion criteria:
Patients with liver and kidney problems
Pregnant or breastfeeding
Patients taking simvastatin interfering drug
Under 16 years old
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are referred to a secretary to be blindly assigned to one of the two groups A and B based on block randomization. Drugs are provided to patients in sealed paper bags on a monthly basis. 2 times a day for the second month (3 times a day and the third and fourth months 4 times a day) and the second group of patients on placebo (made by Shiraz School of Pharmacy).
Blinding (investigator's opinion)
Double blinded
Blinding description
Informed concent will be taken from the participants and they don't know that they are recieving drug or placebo. the investigator and the care giver don't know the intervention and placebo group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Shiraz University of Medical sciences
Street address
Shiraz, Zand street, medical university, ethics comittee
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2016-07-01, 1395/04/11
Ethics committee reference number
IR.SUMS.REC.1395.S257
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Investigation of skin re-pigmentation rate
Timepoint
Months 1, 2, 3 and 4
Method of measurement
Repetition of experiments, photography and scoring
Secondary outcomes
empty
Intervention groups
1
Description
The first group of simvastatin 20 mg made by Iranian company Poursina (first month 2 times a day in the second month 3 times a day in the third and fourth month 4 times a day) and the placebo group (made by Shiraz School of Pharmacy) similar to the first month of simvastatin twice a day and then 3 times a day The third and fourth months are used 4 times a day. Similar to simvastatin, the first month is used twice a day and then 3 times a day and the third and fourth months 4 times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Light therapy department of Shahid Faghihi clinic, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ladan Dastgheib
Street address
Shiraz, Zand St., Shahid Faghihi Educational and Medical Center, Dermatology Clinic, third floor
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Phone
+98 71 3231 9049
Email
dastgh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Shiraz, zand street, shiraz university of medical sciences, 7th floor, vice chancellor of research
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@suma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ladan Dastgheib
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
dastgh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ladan Dastgheib
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz, Zand street, Shahid faghihi hospital, floor 3, Dermatology Department
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
dastgh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Ranjbar
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Others
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
s.ranjbar.mdrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Article
When the data will become available and for how long
Article publication time
To whom data/document is available
researchers
Under which criteria data/document could be used
In order to raise the scientific level of researchers in this field through articles
From where data/document is obtainable
The executor of the plan
What processes are involved for a request to access data/document
Submit a request, review the executor of the project and send feedback