Protocol summary
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Study aim
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Evaluation the efficacy of topical formulation of Falcaria vulgaris plant extract on patients with mild to moderate vitiligo
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Vitiligo area scoring index؛ Repigmentation percent؛ Vitiligo noticeability score
General information
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Reason for update
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The expected start date for patient recruitment has been updated to the actual start date of patient recruitment.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-03-13, 1402/12/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-10-05, 1403/07/14
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Expected recruitment end date
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2025-02-19, 1403/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effectiveness of topical formulation of Falcaria vulgaris extract in patients with vitiligo
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Public title
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Evaluation of the effectiveness of topical formulation of Falcaria vulgaris extract in patients with vitiligo
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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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.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-13, 1402/05/22
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Ethics committee reference number
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IR.TBZMED.PHARMACY.REC.1402.020
Health conditions studied
1
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Description of health condition studied
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Vitiligo
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The size of lesions
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Timepoint
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At the beginning of the study (before the start of the intervention) and 1, 2 and 3 months after the use of topical treatments
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Method of measurement
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Based on the Vitiligo Area Scoring Index - using the hand unit and the amount of depigmentation of the lesion
2
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Description
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Repigmentation percent
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Timepoint
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1, 2 and 3 months after the use of topical treatments
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Method of measurement
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Observationally by comparing with the photograph of the lesion before starting the intervention
Secondary outcomes
1
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Description
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Noticeability of lesions
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Timepoint
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At the end of the study (3 months after the beginning of the intervention)
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Method of measurement
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Vitiligo Noticeability Scale
Intervention groups
1
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Description
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Intervention group: topical cream of Falcaria vulgaris extract, 3% w/w, once daily, for 3 months, apply topical to affected areas
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Category
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Treatment - Drugs
2
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Description
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Control group: betamethasone (as Valerate) topical cream, 0.1%, once daily, for 3 months, apply topical to affected areas
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available