Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU
Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU
Design
A prospective, controlled, parallel-group, simple randomization clinical trial of 20 patients with 60 vitiligo lesions
Settings and conduct
This study will be carried out in Imam Khomeini Hospital of Ahvaz affiliated to the Faculty of Medicine of Ahvaz University of Medical Sciences.
Demographic characteristics of patients including age, sex, family history of vitiligo, description of previous treatments, duration of disease and lesion location are recorded at the beginning. After that, the studied treatments are performed on the patient every week and the results of the previous procedures are also recorded. This work will continue for three months. After completing the study, the patients will be monitored for six months and the amount of changes in the lesion will be recorded.
Participants/Inclusion and exclusion criteria
Patients with stable vitiligo and no new lesions in the previous six months
Except:
pregnant
Lactation
Age under ten years
Facial lesions, genitalia and wrinkled areas
Active Kubner phenomenon
Having coagulation diseases
Patients with active infection
Patient with high risk of keloid and previous history of keloid
Presence of sensitivity to the study drugs
Intervention groups
Three patches are selected for each patient. A patch for combination of microneedling and fluocinolone is applied as a control, second patch for combination of microneedling and local fluorouracil, and third patch for microneedling alone
Main outcome variables
G-Score; Age; Gender; Skin type; Family history; Previous treatments; duration of lesions; Repigmentation start date
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220806055626N1
Registration date:2023-01-08, 1401/10/18
Registration timing:registered_while_recruiting
Last update:2023-01-08, 1401/10/18
Update count:0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Nasrin Kheirkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 3938
Email address
kheirkhah.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU
Public title
Comparison the Effect of Three Different Type of Treatment in Patients Being Treated for Vitiligo Lesions: 1. Microneedling, 2. Microneedling with Topical Fluocinolone and 3. Microneedling with 5-FU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with stable vitiligo without new lesions in the previous six months who have read and signed the consent form
Exclusion criteria:
Pregnant Women
Lactating Mothers
Facial lesions, genitalia and wrinkled areas
Active koebner phenomenon
Having coagulation diseases
Patients with active infection
Patient with high risk of keloid and previous history of keloid
Presence of sensitivity to the study drugs
Age
From 10 years old
Gender
Both
Phase
N/A
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:
60
Vitiligo lesions in homogeneous areas of the patient's skin
Randomization (investigator's opinion)
N/A
Randomization description
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 Golestan Hospital
Street address
Golestan Hospital, Golestan Ave., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.051
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Vitiligo lesions repigmentation
Timepoint
At the beginning of the study; After starting the study every week for three months; Three and six months after completing the study
Method of measurement
The amount of change in the area of the lesion after treatment by examining the photos in color analysis software
Secondary outcomes
1
Description
G-score
Timepoint
After the beginning of repigmentation every week, every month after the end of the study for up to six months
Method of measurement
Color analysis software
2
Description
Repigmentation start time
Timepoint
After starting to study, every week
Method of measurement
Observing the color change through photo analysis
Intervention groups
1
Description
Control group: The combination of microneedling and fluocinolone; In this group, dermapen cartridge 36 (Dr.Pen brand) microneedling with a thickness of 1.5 mm is performed once a week until Pinpoint Bleeding occurs, and after that the patient uses fluocinolone 0.025% cream twice a day.
Category
Treatment - Drugs
2
Description
Intervention group: Microneedling; In this group, microneedling is performed only once a week. Before performing the process of all three patches, the lesion site is numbed for 20 minutes after sterilizing with 70% alcohol using lidocaine cream.
Category
Treatment - Other
3
Description
Intervention group: Combination of microneedling and topical fluorouracil; In this group, microneedling is performed once a week, and immediately after microneedling, 5% FU cream is applied on the surface of the lesion as a thick layer, then the lesion is covered with a closed dressing for 24 hours. After opening the dressing, the desired area is washed and cleaned. Also, the patient uses 5-FU cream topically on the lesion once a day. The duration of treatment for each person is three months, during which the patient undergoes microneedling 12 times with 5-FU cream.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam-Khomeini Hospital
Full name of responsible person
Nasrin Kheirkhah
Street address
Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
info@ajums.ac.ir
Web page address
http://himam.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 4329
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?