Comparison of the efficacy of 5-FU and tacrolimus ointment in the treatment of vitiligo vulgaris
Design
Clinical trial without randomization, without a control group, two parallel intervention groups, double-blind, phase 2 on 40 patients.
Settings and conduct
In this double-blind clinical trial, 40 patients referring to the skin clinic of Imam Khomeini Hospital (RA) and skin and hair clinics in Ilam city were selected and will be randomly divided into two intervention treatment groups between February 1401 and August 1402. For the first intervention group, the use of 0.1% tacrolimus topical ointment and for the second intervention group, the use of 5-fluorouracil (FU-5) ointment on body lesions will be prescribed twice a day.
Participants/Inclusion and exclusion criteria
The presence of at least two vitiligo lesions in the upper, lower and trunk limbs similar in size and color (if the patient had several depigmented lesions, among them two lesions that were similar in size and color were selected would be); Age above 12 years; Have the possibility to refer and follow up; Having consent based on participating in the study; Not using topical treatments in the last month; Fixed or progressive course of the disease in a person; At least 10% of the body surface is affected by this disease; No immune
Intervention groups
Group A patients are treated with tacrolimus ointment and group B patients are treated with 5-fluorouracil (FU-5) ointment.
Main outcome variables
Size of the Vitiligo lesion, percentage of pigmentation of the lesion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230115057128N1
Registration date:2023-02-19, 1401/11/30
Registration timing:registered_while_recruiting
Last update:2023-02-19, 1401/11/30
Update count:0
Registration date
2023-02-19, 1401/11/30
Registrant information
Name
Fatemeh Raoufi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3224 0029
Email address
dr.raoufi.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of 5-FU and tacrolimus ointment in the treatment of vitiligo vulgaris
Public title
comparison of the effectiveness of 5-FU and tacrolimus ointment in the treatment of vitiligo vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of at least two vitiligo lesions in the upper, lower and trunk limbs similar in size and color (if the patient had several depigmented lesions, among them two lesions that were similar in size and color were selected would be)
Age above 12 years
have the possibility to refer and follow up
Consent based on participating in the study
Not using topical treatments in the last month
The steady or progressive course of the disease in a person
Occupancy of at least 10% of the body surface by this disease
Not having an immune deficiency
Exclusion criteria:
Patients with skin lesions on the face
Cases of segmental vitiligo
pregnancy
Inability to track treatment results
Age
From 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In the questionnaire, each patient's lesion will be marked with code 1 and 2, and the researcher will not know the type of drug used in each location until the time of analysis.The patient does not know the type of medicine by giving the medicine in special containers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Research and Technology Blvd., Ilam University of Medical Sciences campus, Banganjab, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MEDILAM.REC.1401.187
Health conditions studied
1
Description of health condition studied
vitiligo vulgaris
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Size of the lesion
Timepoint
Examining the lesions at the beginning of the study and the second, fourth and sixth months after the start of treatment
Method of measurement
VASI scoring system
2
Description
Percentage of pigmentation
Timepoint
Examining the lesions at the beginning of the study and the second, fourth and sixth months after the start of treatment
Method of measurement
VASI scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: For the first intervention group, the use of 0.1% tacrolimus topical ointment on body lesions will be prescribed twice a day (in the morning after waking up and at night before going to bed).
Category
Treatment - Drugs
2
Description
Intervention group 2: For the second intervention group, the use of 5-fluorouracil (FU-5) ointment on body lesions twice a day (in the morning after waking up and at night before going to bed) will be prescribed.