Investigation of the effect of Microneedling with topical Fluorouracil (5-FU) in treatment of Vitiligo
Design
This is a clinical trial study that has control group, with a parallel group, randomized without blinding.This study will be performed on 20 patients from March to September 2020.
Settings and conduct
This study will be conducted at Imam Khomeini Hospital related to Ahvaz University of Medical Sciences. In each patient, two patches are selected and after randomization, one patch receives topical Tacrolimus drug as a control and the other receives a combination of topical Microneedling and a
Fluorouracil.
Participants/Inclusion and exclusion criteria
All patients with stable Vitiligo can enter the study.
Excluding criterias are: under 10 years of age, pregnant and lactating women, facial lesions and intertriginous areas and genitalia, active infection, history of keloid, drug allergy, coagulopathy history and active Koebner phenomenon
Intervention groups
One group receives Microneedling with topical Fluorouracil and the control group receives topical Tacrolimus ointment.
Main outcome variables
Response rate to Vitiligo treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200506047320N1
Registration date:2020-06-30, 1399/04/10
Registration timing:registered_while_recruiting
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Mohammad Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3636 4577
Email address
hatami.mo@mail.ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Microneedling plus topical 5-FU versus topical Tacrolimus in the Treatment of Vitiligo Patients
Public title
Microneedling plus topical 5-FU in treatment of Vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with stable vitiligo
Exclusion criteria:
Pregnancy and lactation
Age under 10 y
Lesions on face, genitalia and intertriginous areas
Active Koebner phenomenon
Coagulopathy
Active infection
Previous history of keloid or high risk for keloid
Drug hypersensitivity
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One sample receives topical Tacrolimus and other receives Microneedling plus 5FU
Randomization (investigator's opinion)
Randomized
Randomization description
Double randomized blocks containing treatment A and B are used to randomize the allocation of treatments to patients. To do this, two types of blocks; AB (where treatment B for the right and treatment A for the left) and BA (where treatment A for the right and treatment B for the left) are considered. By throwing a dice, if the even number appears, the AB block and if the odd number appears, the BA block is used to assign therapies to the patients.
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 Ahvaz University of Medical Sciences
Street address
9/1 Alley,Shahamat Ave., Akbarabad Blvd., Shiraz town
City
Ahvaz
Province
Khouzestan
Postal code
7196881117
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.AJUMS.REC.1398.983
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Repigmentation level in Vitiligo lesions
Timepoint
At beggining of study and then after treatmen starts every 2 weeks for 3 months
Method of measurement
Based on the percentage of repigmentation and classification as 0 to 25 percent, 25 to 50, 50 to 75 and above 75 percent.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group that receives a combination of Microneedling and topical Fluorouracil solution 50 mg/ml every two weeks for 3 months.
Category
Treatment - Drugs
2
Description
Control group: A group that uses topical Tacrolimus 0.1% twice daily for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Khomeini Hospital in Ahvaz
Full name of responsible person
Nader Pazyar
Street address
9/1 Alley, Shahamat Ave., Akbarabad Blvd., Shiraz town
City
Shiraz
Province
Fars
Postal code
7196881117
Phone
+98 71 3636 4577
Email
Hatami.mo@mail.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Pazyar
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 3817
Email
Hatami.mo@Mail.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Hatami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahamat Ave., Akbarabad Blvd.
City
Shiraz
Province
Fars
Postal code
7196881117
Phone
+98 71 3636 4577
Fax
Email
Hatami.mo@mail.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Pazyar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 1837
Fax
Email
Dr.pazyar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Hatami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahamat Ave., Akbarabad Blvd.
City
Shiraz
Province
Fars
Postal code
7196881117
Phone
+98 71 3636 4577
Fax
Email
Hatami.mo@mail.ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be published and shared after the study performed.
When the data will become available and for how long
3 months after publishing the results
To whom data/document is available
All groups and individuals
Under which criteria data/document could be used
There are no specific conditions at this moment.
From where data/document is obtainable
By contact with this email address
Hatami.mo@mail.ajums.ac.ir
What processes are involved for a request to access data/document
After submitting the request, data will be provided to them within a month