Comparison of the effect of Vitilexin Gyorel and placebo in vitiligo patients undergoing phototherapy
Design
A clinical trial with a control group, with parallel groups, double-blinded, randomized, phase 3 on 66 patients. Random Allocation software is used for randomization.
Settings and conduct
This study is conducted on patients with vitiligo who are referred to skin clinics of Shiraz University of Medical Sciences. Patients' lesions are randomly divided into two groups (right and left lesions). The plan is implemented in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. The patient's age is over 18 years 2. The presence of at least 2 vitiligo corneal lesions in the upper, and lower limbs, face, or trunk that are similar in size and color 3. The disease is under control (non-progressive). 4. Involvement of at least 10% of the body surface 5. Patients are willing to participate in the study. Exclusion criteria: 1. Use of topical medications in the last month 2. Having an immune deficiency 3. Any contraindication for phototherapy such as a history of skin cancer 4. Pregnant and lactating women
Intervention groups
One of the lesions located on one side of the body will receive Vitilexine Cream Givrelle twice a day for three months. Control group: One of the lesions located on the other side of the body will receive a placebo twice a day for three months. Same treatment for both groups: patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. Phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months.
Main outcome variables
Severity of disease using Vitiligo Area Scoring Index (VASI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N21
Registration date:2023-11-15, 1402/08/24
Registration timing:prospective
Last update:2023-11-15, 1402/08/24
Update count:0
Registration date
2023-11-15, 1402/08/24
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
2023-11-21, 1402/08/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Vitilexine Cream Givrelle in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy
Public title
The effect of Vitilexine Cream Givrelle in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's age is over 18 years
The presence of at least 2 vitiligo corneal lesions in the upper, lower limbs, face or trunk that are similar in size and color
The disease is under control (non-progressive).
Involvement of at least 10% of the body surface
Patients willing to participate in the study
Exclusion criteria:
Use of topical medications in the last month
Having an immune deficiency
Any contraindication for phototherapy such as a history of skin cancer
Pregnant and lactating women
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
70
One of the lesions on one side of the body will be selected as intervention and the lesion on the other side will be selected as control
Randomization (investigator's opinion)
Randomized
Randomization description
By using Random Allocation Software, consecutive permutation blocks with the size of 4 lesions in each block are made and the lesions are divided into two groups A (right side) and B (left side). Dark-colored envelopes will be used to hide random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the researcher, the drugs are named A (Vitilexine Cream Givrelle) and B (placebo cream). The drug and placebo are similar in terms of shape, color, and consistency. The patient is also not aware of the type of medicine assigned to him. Also, the groups are coded as A and B and delivered 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
2023-08-12, 1402/05/21
Ethics committee reference number
IR.SUMS.MED.REC.1402.208
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Severity of vitiligo
Timepoint
Before the intervention, 6 weeks later, 12 weeks later
Method of measurement
Vitiligo Area Scoring Index (VASI)
Secondary outcomes
empty
Intervention groups
1
Description
One of the lesions located on one side of the body will receive Vitilexine Cream Givrelle twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again.
Category
Treatment - Drugs
2
Description
Control group: One of the lesions located on one side of the body will receive placebo twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Dermatology Clinic
Full name of responsible person
Dr. Nasrin Saki
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348466114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Street address
7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.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. Samaneh Yekran
Position
Dermatology resident
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
s_yekran@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasrin Saki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
nasrinsa85@yahoo.com
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
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
One year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews.
From where data/document is obtainable
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
What processes are involved for a request to access data/document
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
Comments
Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.