This study will be conducted to compare the effectiveness and side effects of topical administration of 5-FU and microneedling of 5-FU in patients with stable vitiligo.
Design
The current study will be a parallel phase 3 randomized clinical trial and the target population is people over 18 years old with stable vitiligo. The sample size of this study is between 5 and 6 patients per month according to the referral of patients with stable vitiligo in the previous months and the length of the current study is 7 months. According to the estimate of 80%, the number of patients during the study period is estimated to be 30. In previous similar studies, the number of patients with stable vitiligo was 30. The participants will be selected by convenient sampling and 15 people will be randomly assigned to the 5-FU microneedling group and 15 people to the 5-FU topical administration group. For patients referred with stable vitiligo, a patient code will be defined and the patients will be randomly assigned to one of the groups using a table of random numbers.
Settings and conduct
This study will be conducted in Tabriz Sinai Hospital. Patients in the microneedling group will undergo microneedling every two weeks for 3 months (six sessions). Then microneedling will be done using Dermapen at a needle depth between 0.25 mm and 0.5 mm and in two passes in different directions. After that, 5-fluorouracil liquid will be used. In the local treatment group with 5-FU, the patients will use 5-FU topically on the lesions twice a day. Due to the different nature of interventions, it is not possible to blind people.
Participants/Inclusion and exclusion criteria
People over 18 years old with stable vitiligo who do not have other systemic diseases.
Intervention groups
Microneedling plus topical 5-Fluorouracil versus topical 5-Fluorouracil
Main outcome variables
the color of vitiligo spots; Pigmention score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221105056407N2
Registration date:2024-04-20, 1403/02/01
Registration timing:registered_while_recruiting
Last update:2024-04-20, 1403/02/01
Update count:0
Registration date
2024-04-20, 1403/02/01
Registrant information
Name
Hooman Nateghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3741
Email address
nategh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Topical Fluorouracil vs Microneedling with Fluorouracil in Patients with Stable Vitiligo
Public title
Microneedling with Fluorouracil in Patients with Stable Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No new lesions and no progression of existing lesions for at least 2 years
Exclusion criteria:
pregnancy
allergy to 5- Fluorouracil
Patients with infectious patches, vitiligo spots on the mucous membrane, Kubner's phenomenon, tendency to keloid or hypertrophic scars.
Coagulation disorders
Other uncontrolled systemic diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
For patients referred with stable vitiligo, a patient code will be defined and the patients will be randomly assigned to one of the groups using a table of random numbers.
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 Tabriz University of Medical Sciences
Street address
Attar neyshabouri St, Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TBZMED.REC.1402.969
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Discoloration of vitiligo spots
Timepoint
Evaluation of lesions in both groups will continue every month until three months after the end of the interventions
Method of measurement
Discoloration of vitiligo patches will be graded as 1 (no response, milky white color still present, or erythematous color), 2 (opaque white color change), 3 (light brown color change), and 4 (normal skin color). Evaluation will also be done using the pigment score, which compares baseline vitiligo status and percent improvement as follows: 0, no response, <25% poor response, 25%–50% good response, 50%–75% Very good response, >75%, excellent response
Secondary outcomes
1
Description
Treatment complications
Timepoint
Evaluation of lesions in both groups will continue every month until three months after the end of the interventions
Method of measurement
Examination and history taking by the doctor
Intervention groups
1
Description
Control group: topical 5-Fluorouracil. In the 5-FU topical treatment group, patients will use 5-Fluorouracil topically on the lesions twice daily. The medicine will be in topical form and EFUDIX Ointment 5%, 20 g.
Category
Treatment - Drugs
2
Description
Intervention group: Microneedling with 5-Fluorouracil. Patients in the microneedling group will undergo microneedling every two weeks for 3 months (six sessions). In this method, we first sterilize the vitiligo patch with 70% alcohol. Then microneedling will be done using Dermapen (Dr. Pen ULTIMA A1-W, USA) with a needle depth between 0.25 mm and 0.5 mm and in two passes in different directions (vertical, horizontal and oblique). This was followed by 5-fluorouracil liquid (Utoral 500 mg/10 ml vial, undiluted) (Hikma Specialized Pharmaceuticals, Egypt). The amount of liquid used will be determined according to the size of the patch. Liquid instillation was done by a 1 ml insulin syringe. In this method, we will ask patients to sit for 30 minutes after microneedling to check side effects.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Sina hospital
Full name of responsible person
Hamideh Harizchi Gadim
Street address
Azadi St. - Sina Hospital - Dermatology Department -
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
drherizchi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Attar Nishaburi Street, Tabriz Medical School
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 3207
Email
info.medfac@tbzmed.ac.ir
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
Seyyede Haleh Sadroleslami
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
خیابان آزادی- بیمارستان سینا- بخش پوست
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3335 7314
Email
haleh.sadreslami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamideh Harizchi Gadim
Position
Resident of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
خیابان آزادی- بیمارستان سینا- بخش پوست
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3335 7314
Email
drherizchi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyyede Haleh Sadroleslami
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
خیابان آزادی- بیمارستان سینا- بخش پوست
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3335 7314
Email
haleh.sadreslami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The anonymous data will be provided upon receiving reasonable request.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions as well as people who are also engaged in industry.
Under which criteria data/document could be used
Any secondary analysis on the data from this study will be allowed.
From where data/document is obtainable
Dr Seyyede Haleh Sadroleslami
haleh.sadreslami@gmail.com
What processes are involved for a request to access data/document
The anonymous data will be provided upon receiving reasonable request via email.