Determination of the effect of photo-therapy plus Simvastatin tablet in comparison with photo-therapy plus placebo in the treatment of patients with vitiligo referred to Shahid Faghihi Dermatology Clinic
Design
Two arm parallel group randomized clinical trial, double blinded
Settings and conduct
Samples include the patients with vitiligo who refer to the Shahid Faghih Dermatology Clinic. In order to blind the investigator and patients, medications are named as "A" for Simvastatin tablet and B for placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Patients with vitiligo, 2- Involving more than 20% of the body surface, 3- Age above 14 years old. Exclusion criteria: 1- Patients with systemic diseases, 2- Patients who use other therapeutic methods except photo-therapy, 3- Patients with any liver diseases, 4- Patients with any kidney diseases, 5- Pregnant and lactating women, 6- History of allergy to photo-therapy, 7-Taking medication that has interactions with Simvastatin.
Intervention groups
Intervention group: the initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of Simvastatin (manufactured by Pursina Company) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months. Control group: the initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of placebo (manufactured by Shiraz School of Pharmacy) is similar to dose of prescribed Simvastatin.
Main outcome variables
The amount of melanin pigment in the skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N11
Registration date:2019-03-30, 1398/01/10
Registration timing:retrospective
Last update:2019-03-30, 1398/01/10
Update count:0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-02-28, 1395/12/10
Trial completion date
2017-08-21, 1396/05/30
Scientific title
A comparative study on the therapeutic effect of combined phototherapy and oral Simvastatin with phototherapy alone in patients with vitiligo
Public title
The effect of phototherapy and oral Simvastatin in treatment of vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with vitiligo
Age above 14 years old
Exclusion criteria:
Patients with systemic diseases
Patients who use other therapeutic methods except light therapy
Patients with any liver disease
Patients with any kidney disease
Pregnant and lactating women
History of allergy to phototherapy
Taking medication that has interactions with simvastatin
Age
From 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink was used to create a randomization table
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the investigator, medications were named A (simvastatin tablet) and B (Placebo). The patients were not aware of which drug they received. The groups were also coded A and B to the statistical analyzer
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical School of Shiraz University of Medical Sciences
Street address
Medical School of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.SUMS.MED.REC.1395.20
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
The amount of melanin pigment in the skin
Timepoint
Assessment the amount of melanin pigment at the start of the study and at the end of the first, second, third and fourths month after beginning the treatment
Method of measurement
Vitiligo Area Scoring Index (VASI Score)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of Simvastatin (manufactured by Pursina Company) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months
Category
Treatment - Drugs
2
Description
Control group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of placebo (manufactured by Shiraz School of Pharmacy) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Ladan Dastgheib
Street address
Shahid Faghihi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
dastghl@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Shiraz University of medical Sciences, Research vice, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7252
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
93-01-01-9021
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
Shahid Faghihi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
dastghl@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
Shahid Faghihi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
dastghl@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@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
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document