Determination of efficacy of Tofacitinib ointment in the treatment of vitiligo
Design
A clinical trial with a control group, with parallel groups, double-blinded, randomized, phase 3 on 46 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, including intervention and control groups. The plan is implemented in a double-blind manner.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. Age over 18 years. 2. Presence of depigmented lesions on the upper extremities, lower extremities, face, or trunk that are similar in size and color. 3. No use of any topical medications in the past month. 4. Stable or progressive course of the disease. 5. Involvement of at least 20% of the body surface area. Exclusion Criteria: 1. History of any skin cancer or immunodeficiency. 2. Unwillingness to participate in the study. 3. Inability to follow up or attend follow-up appointments.
Intervention groups
Patients on one side of the body receive tofacitinib ointment as the intervention group, which should be applied once daily for three months. Patients on the opposite side of the body receive a topical placebo as the control group, which is also applied once daily for three months.
Main outcome variables
VASI; VAS; Patient global assessment (PGA); physician global assessment(PGA); Side effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150825023753N27
Registration date:2025-04-20, 1404/01/31
Registration timing:prospective
Last update:2025-04-20, 1404/01/31
Update count:0
Registration date
2025-04-20, 1404/01/31
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
2025-05-21, 1404/02/31
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of tofacitinib ointment in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy
Public title
Effect of tofacitinib in the treatment of patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over ۱۸ years
Presence of depigmented lesions in the upper, lower limbs, face or trunk that are similar in size and color
Not using any topical drugs in the last one month
Stable or progressive course of the disease
Involvement of at least ۲۰% of the body surface
Consent to participate in this study
Exclusion criteria:
Any history of skin cancer or immunodeficiency,
Unwillingness to participate in the study
The impossibility of follow-up and refer for follow-up
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, selected patients must have at least ۲ similar lesions of the same color and size; therefore, one of the lesions on one side of the body as an intervention and the lesion on the other side will be selected as a control. Intervention lesions will be treated by tofacitinib ointment and control lesions by placebo, which is completely identical in shape, color and consistency to the original drug.
In the information form, the lesions on each side of the patient will be marked with code ۱ and ۲, and two ointments will be distributed under the code A and B. The researcher will not know about the type of drug until the time of data analysis.
To randomize the patients, the code number one belongs to the right side and number two to the left side. These two numbers are placed separately in a closed envelope. The letters A and B are placed separately in two envelopes .Each patient randomly chooses an envelope of numbers and an envelope of letters. Based on that Which number and which letter he chooses, the right or left side will be treated with ointment containing code A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done in such a way that the content of A and B ointments will be divided by the drug manufacturer, and only the drug manufacturer know about the content of the tubes .Collecting information before, ۴۵ days and ۹۰ days after the procedure will be done by the project executor and the patient and the project executor will not be aware of the type of ointments.
In the data analysis stage, the project executor analysis the data with the name of the groups (so they will not be aware of the description of the operation).
Therefore, this study is double-blind, and the contents of the two groups of ointments will not be known from the stage of the patient's entry into the study until the completion of the study, data collection and data analysis.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Of Medical Science
Street address
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7134846114
Approval date
2024-08-30, 1403/06/09
Ethics committee reference number
IR.SUMS.MED.REC.1403.367
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Vitiligo
Timepoint
0,45,90 days later
Method of measurement
Physical exam
Secondary outcomes
1
Description
Vitiligo Area Scoring Index
Timepoint
0,45,90 days later
Method of measurement
The information form for the Vitiligo Area Scoring Index (VASI)
Intervention groups
1
Description
Intervention group: receiving daily tofacitinib ointment for three month.
Category
Treatment - Drugs
2
Description
Control group: receiving placebo daily for three month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital
Full name of responsible person
Mehdi Ghahartars
Street address
Shahid Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1099
Email
mghahar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research vice, Shiraz University Of Medical Sciences, Zand street, Shiraz
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2710
Email
Hashempour@gmail.com
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
Maryam Hekmat
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Ward of Shahid Faghihi Hospital,zand street
City
shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1099
Email
m.hekmat1997@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Ghahartars
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
The Dermatology Department of Faghihi Hospital, Zand Street,Shiraz
City
shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1099
Email
Mghahar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Parvizi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Zand Street, Dermatology Department of Shiraz University of Medical Sciences, Skin Molecular Research Center.
City
shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1099
Email
parvizim@sums.ac.ir
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
starting 6 months after publication
To whom data/document is available
The data will be accessible to researchers working at academic and scientific institutions as well as those employed in the industry.
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.