Comparing the outcomes of 1% pimecrolimus cream with 0.1% mometasone cream in treatment of childhood vitiligo in the face, neck and trunk
Design
Randomised, superiority, parallel group trial with not blinded outcome assessment. Randomisation was centralised and computerised with random number generation. study population will be 64 cases in 2 groups.
Settings and conduct
the patients referred to alzahra and sedighe tahere dermatology clinics of Isfahan who are under 18 will be included in the study and will get visited at the start of the study, and 2 and 3 months after the initiation of the treatment. the patients own satisfication of the treatment and the decrease in the lesions size will be assessed and all the lesions will get photographed and the improvement in pigmentation will be assessed and scored by two expert dermatologists
Participants/Inclusion and exclusion criteria
entrance conditions include vitiligo lesion in less than 10 percent of body surface , non segmental vitiligo, no history of allergic reaction to used drugs
excluding criteria includes pregnancy, lactating, using other treatments for vitiligo in the last 6 months, allergic reaction to used drugs
Intervention groups
first group goes under treatment using pimecrolimus 1% topically twice a day and the second group of intervention goes under treatment with mometasone 0.1% topically daily.
Main outcome variables
Visual Analogue Scale score of improvement according to the patients; mean decrease in lesions size; pigmentation improvement in the lesions according to 2 experts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230307057646N1
Registration date:2023-05-19, 1402/02/29
Registration timing:prospective
Last update:2023-05-19, 1402/02/29
Update count:0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
Sarah Seyedyousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3630 5800
Email address
sarah.syousefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-04-03, 1403/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the outcomes of 1% pimecrolimus cream with 0.1% mometasone cream in treatment of childhood vitiligo in the face, neck and trunk
Public title
Comparing the outcomes pimecrolimus and mometasone cream in treatment of childhood vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Vitiligo in less than 10 percent of body surface
non-segmental vitiligo
no history of allergic reaction to used drugs
Exclusion criteria:
pregnancy and lactating
using other treatments for vitiligo lesions in last 6 months
severe allergic reactions to used drugs
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
31 random numbers were generated using the random number generator function of the website calculator.net. the participants are numbered according to the order of addition to the study and the participants with the numbers mentioned before, will be assigned to the group with pimecrolimus as a treatment and others will be assigned to the mometasone group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Ethics Committee of Isfahan university of medical sciences , Isfahan university of medical sciences, hezar jarib avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.ARI.MUI.REC.1401.322
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Visual Analogue Scale score of improvement according to the patients
Timepoint
3 months after the initiation of the treatments
Method of measurement
patients score the improvement from 1-10
2
Description
mean changes in lesions size
Timepoint
2 and 3 months after the initiation of the treatment
Method of measurement
millimeter sensitive ruler
3
Description
pigmentation improvement in the lesions according to 2 experts
Timepoint
2 and 3 months after the initiation of the treatment
Method of measurement
2 experts in dermatology scoring the improvement from 0 to 3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pimecrolimus 1% cream, topical use , twice a day for 2 months
Category
Treatment - Drugs
2
Description
Intervention group: Mometasone 0.1% cream, topical use , daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Fariba Iraji
Street address
Sofeh Blvd , Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/fa
2
Recruitment center
Name of recruitment center
Sedigheh Tahereh dermatology clinic
Full name of responsible person
Dr. Fariba Iraji
Street address
Khorram Street , Sedigheh Tahereh Clinic
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3339 0101
Email
dean@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr gholamreza Asgari
Street address
research and technology vice chancellery of Isfahan university of medical sciences, Isfahan university of medical sciences, Hezar jarib avenue, Isfahan , Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://researchold.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Seyedyousefi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
Student Research Committee, Isfahan University of Medical Sciences, hezarjarib avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3630 5800
Email
Sarah.syousefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Seyedyousefi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
Student Research Committee, Isfahan University of Medical Sciences, hezarjarib avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8166755773
Phone
0098363305800
Email
Sarah.syousefi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Seyedyousefi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
Student Research Committee, Isfahan University of Medical Sciences, hezarjarib avenue, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8166755773
Phone
+98 31 3630 5800
Email
Sarah.syousefi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
the possible decline of cooperation by parents considering the cultural background
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
patients data will not be available and only the final result (the changes in lesion size and pigmentation and patients' satisfaction) will be published.
study method and analysis will be publicly available for interested fellow researchers.
When the data will become available and for how long
6 months after publication
To whom data/document is available
active people in research fields
Under which criteria data/document could be used
active people in research fields who don't have access to the databases can send a request to get access to the data. researchers who are willing to do complementary research projects on the matter can have access to the analysis and the study method.
researcher willing to do metanalysis on the matter can request for the data.
From where data/document is obtainable
corresponding author can be accessed via these ways:
Sarah Seyedyousefi
E-mail: Sarah.syousefi@gmail.com
postal Address: no.25 , anahita alley , akbaralsadat alley, 15th khordad street, Isfahan
phone number: +989226738926
What processes are involved for a request to access data/document
researchers can request for the data by emailing the corresponding author and providing reasonable explanation