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General information
2024-04-08, 1403/01/20
2024-10-05, 1403/07/14
2024-0410-0805 00:00:00
2024-07-10, 1403/04/20
2025-02-19, 1403/12/01
20242025-0702-1019 00:00:00
empty
The expected start date for patient recruitment has been updated to the actual start date of patient recruitment.
The expected start date for patient recruitment has been updated to the actual start date of patient recruitment.
empty
تاریخ شروع بیمار گیری مورد انتظار به تاریخ بیمار گیری محقق شده به روز رسانی شده است.
تاریخ شروع بیمار گیری مورد انتظار به تاریخ بیمار گیری محقق شده به روز رسانی شده است.
Intervention groups
#1
Intervention group: topical cream of Falcaria vulgaris extract, 3% w/w, twice daily, for 3 months, apply topical to affected areas
Intervention group: topical cream of Falcaria vulgaris extract, 3% w/w, once daily, for 3 months, apply topical to affected areas
Intervention group: topical cream of Falcaria vulgaris extract, 3% w/w, twiceonce daily, for 3 months, apply topical to affected areas
گروه مداخله: کرم موضعی عصاره گیاه فالکاریا ولگاریس، ۳٪ وزنی/وزنی ، دو بار در روز، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
گروه مداخله: کرم موضعی عصاره گیاه فالکاریا ولگاریس، ۳٪ وزنی/وزنی ، یک بار در روز، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
گروه مداخله: کرم موضعی عصاره گیاه فالکاریا ولگاریس، ۳٪ وزنی/وزنی ، دویک بار در روز، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
#2
Control group: betamethasone (as Valerate) topical cream, 0.1%, for 3 months, apply topical to affected areas
Control group: betamethasone (as Valerate) topical cream, 0.1%, once daily, for 3 months, apply topical to affected areas
Control group: betamethasone (as Valerate) topical cream, 0.1%, once daily, for 3 months, apply topical to affected areas
گروه کنترل: کرم موضعی بتامتازون (به صورت والرات)، ۰.۱٪، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
گروه کنترل: کرم موضعی بتامتازون (به صورت والرات)، ۰.۱٪، یک بار در روز، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
گروه کنترل: کرم موضعی بتامتازون (به صورت والرات)، ۰.۱٪، یک بار در روز، به مدت ۳ ماه، روی مناطق درگیر مالیده شود
Recruitment centers
#1
Name of recruitment center - English: Sina educational, research and treatment center
Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی سینا
Full name of responsible person - English: Sanam Javadzadeh
Full name of responsible person - Persian: صنم جوادزاده
Street address - English: Azadi Street between Hafez and Shahid Montazeri intersections
Street address - Persian: تبریز:خیابان آزادی مابین چهار راه حافظ و چهار راه شهید منتظری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5163639888
Phone: +98 41 3549 8465
Fax:
Email: sinahospital@tbzmed.ac.ir
Web page address: https://sinahosp-en.tbzmed.ac.ir/
Name of recruitment center - English: Sina educational, research and treatment center
Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی سینا
Full name of responsible person - English: Sanam Javadzadeh
Full name of responsible person - Persian: صنم جوادزاده
Street address - English: Azadi Street between Hafez and Shahid Montazeri intersections, Tabriz Twn
Street address - Persian: تبریز، خیابان آزادی، مابین چهار راه حافظ و چهار راه شهید منتظری
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5163639888
Phone: +98 41 3549 8465
Fax:
Email: sinahospital@tbzmed.ac.ir
Web page address: https://sinahosp-en.tbzmed.ac.ir/
Name of recruitment center - English: Sina educational, research and treatment center Name of recruitment center - Persian: مرکز آموزشی، پژوهشی و درمانی سینا Full name of responsible person - English: Sanam Javadzadeh Full name of responsible person - Persian: صنم جوادزاده Street address - English: Azadi Street between Hafez and Shahid Montazeri intersections, Tabriz Twn Street address - Persian: تبریز:، خیابان آزادی، مابین چهار راه حافظ و چهار راه شهید منتظری City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5163639888 Phone: +98 41 3549 8465 Fax: Email: sinahospital@tbzmed.ac.ir Web page address: https://sinahosp-en.tbzmed.ac.ir/
Protocol summary
Study aim
Evaluation the efficacy of topical formulation of Falcaria vulgaris plant extract on patients with mild to moderate vitiligo
Design
Randomized, parallel, controlled clinical trial on 36 patients, will be followed for 3 months, each patient's control group is himself, excel software was used for randomization
Settings and conduct
In order to evaluate the topical formulation of Falcaria vulgaris plant extract, 36 patients with the age group of 18 to 65 years will be selected. Patients with vitiligo on the trunk and limbs will be selected from patients referred to dermatologist and professor of Tabriz University of Medical Sciences.
Patients who have bilateral vitiligo lesions will be included in the study. After obtaining informed consent, patients' lesions will be randomized using block randomization technique, and symmetric lesions will receive one of the intervention and control treatments. Patients receive their medicines on a monthly basis while evaluating the treatment response and continue the drug therapy for up to 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with mild to moderate vitiligo who have at least 2 symmetric skin lesions and have not progressed in the lesions in the past 6 months. Exclusion criteria include pregnant or lactating patients, patients with mental retardation, patients with severe vitiligo, History of contact dermatitis، and patients with intervening skin diseases.
Intervention groups
In this study, the effectiveness of the herbal treatment will be compared with the standard treatment. Herbal treatment includes a topical formulation of the Falcaria vulgaris extract and the standard treatment will be betamethasone (as valerate) 0.1% cream.
Main outcome variables
Vitiligo area scoring index؛ Repigmentation percent؛ Vitiligo noticeability score
General information
Reason for update
The expected start date for patient recruitment has been updated to the actual start date of patient recruitment.
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059569N1
Registration date:2024-03-13, 1402/12/23
Registration timing:prospective
Last update:2024-12-05, 1403/09/15
Update count:1
Registration date
2024-03-13, 1402/12/23
Registrant information
Name
Sanam Javadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 7355
Email address
sanam.javadzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-05, 1403/07/14
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of topical formulation of Falcaria vulgaris extract in patients with vitiligo
Public title
Evaluation of the effectiveness of topical formulation of Falcaria vulgaris extract in patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate vitiligo
Patients who have at least two symmetric skin lesions
Not suffering from skin diseases, such as allergies, etc.
Not suffering from light-sensitive diseases such as lupus and porphyria,
Not using photosensitizing drugs such as retinoids
Patients who have not received systemic treatment for vitiligo in the past one month and during this period
Patients with lesions that are homogeneous in terms of size, location, and duration of the lesion, and stable so that the lesion did not spread for at least the last 6 months.
Exclusion criteria:
Pregnancy and lactation
Patients with severe vitiligo
History of contact dermatitis
Having other skin diseases that affect the study
Patient dissatisfaction
Case of drug allergy
Face and axillary and inguinal region involvement
Mentally retarded patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
2
Each person with at least two symmetric lesions on the right and left side is considered as a complete block, and the lesions on each side of the body will be randomly assigned to one of the possible permutations for the intervention and control treatments. In fact, each person's control group is himself. On one side of the symmetric organ, the cream under study, and on the other side, betamethasone (as valerate) 0.1% cream will be used.
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Randomization Unit: Individual (skin lesion)
Each person with at least 2 symmetric lesions is considered as a complete block.
Randomization tool: Excel software
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
Reasearch ethics committee of faculty of pharmacy, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, North Attar Neishabouri St, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.TBZMED.PHARMACY.REC.1402.020
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The size of lesions
Timepoint
At the beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the use of topical treatments
Method of measurement
Based on the Vitiligo Area Scoring Index - using the hand unit and the amount of depigmentation of the lesion
2
Description
Repigmentation percent
Timepoint
1, 2 and 3 months after the use of topical treatments
Method of measurement
Observationally by comparing with the photograph of the lesion before starting the intervention
Secondary outcomes
1
Description
Noticeability of lesions
Timepoint
At the end of the study (3 months after the beginning of the intervention)
Method of measurement
Vitiligo Noticeability Scale
Intervention groups
1
Description
Intervention group: topical cream of Falcaria vulgaris extract, 3% w/w, once daily, for 3 months, apply topical to affected areas
Category
Treatment - Drugs
2
Description
Control group: betamethasone (as Valerate) topical cream, 0.1%, once daily, for 3 months, apply topical to affected areas
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina educational, research and treatment center
Full name of responsible person
Sanam Javadzadeh
Street address
Azadi Street between Hafez and Shahid Montazeri intersections, Tabriz Twn
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8465
Email
sinahospital@tbzmed.ac.ir
Web page address
https://sinahosp-en.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research and Technology Vice-Chancellor, 3rd floor, central building No.2, Tabriz University of Medical Sciences, Golgasht St,
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sanam Javadzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
19th floor, unit 3, Sahand Tower, Vanak Park Complex, Agha Alikhani Street, South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1436943535
Phone
+98 21 8803 7355
Fax
Email
sanam.javadzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanam Javadzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
19th floor, unit 3, Sahand Tower, Vanak Park Complex, Agha Alikhani Street, South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1436943535
Phone
+98 21 8803 7355
Fax
Email
sanam.javadzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sanam Javadzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
19th floor, unit 3, Sahand Tower, Vanak Park Complex, Agha Alikhani Street, South Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1436943535
Phone
+98 21 8803 7355
Fax
Email
sanam.javadzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available