The aim of this study was to evaluate the effect of oral hydroxychloroquine in the treatment of generalized vitiligo vulgaris
Design
quasi-experimental study (before and after) with single group design on 15 patients
Settings and conduct
This quasi-experimental study (before and after) on patients with generalized vulgaris vulgaris who referred to the dermatology clinic of Ghaem and Imam Reza (AS) hospitals and the dermatology clinic of 22 Bahman hospital who met the inclusion criteria was done. Fifteen patients were included in the study and their improvement rate was assessed based on the VASI score criterion.
Participants/Inclusion and exclusion criteria
Inclusion criterias
Involvement of at least 10% of body surface
At least one month has passed since the last treatment for the patient
Not receiving any other treatment
Not taking other drugs at the same time with immunomodulatory and immunosuppressive effects
Over 7 years old
Weight over 35 kg
Do not take drugs that interfere with hydroxychloroquine, such as Artemether and Dapsone and Lumefantrine
Exclusion criterias
Glucose-6-phosphate dehydrogenase deficiency
Retinopathy
Sensitivity to antimalarial compounds
Renal failure
Psoriasis
Myasthenia gravis
Acute gastrointestinal disorders
Hepatic failure
Intervention groups
HCQ was orally administered 400 mg daily (∼6.5 mg/Kg of body weight) by 15 patients with generalized vitiligo for three months. Patients were evaluated monthly and skin re-pigmentation was assessed using the VASI.
Main outcome variables
Complications ; Extent and intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201212049690N1
Registration date:2020-12-28, 1399/10/08
Registration timing:retrospective
Last update:2020-12-28, 1399/10/08
Update count:0
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
soudabeh sazgarnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 5556
Email address
soodabe.sn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2020-08-31, 1399/06/10
Trial completion date
2020-08-31, 1399/06/10
Scientific title
Evaluation of oral Hydroxy Choloroquine on treatment of Generalized Vitiligo Vulgaris
Public title
Evaluation of Hydroxy Choloroquine on Generalized Vitiligo Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Involvement of at least 10% of body surface
At least one month has passed since the last treatment for the patient
Not receiving any other treatment
Not taking other drugs at the same time with immunomodulatory and immunosuppressive effects
Over 7 years old
Weight over 35 kg
Do not take drugs that interfere with hydroxychloroquine, such as Image result for artemether and Dapsone and Lumfanterin
Ethics committee of Islamic Azad University of Mashhad
Street address
2nd Floor, No. 152, Nastaran 18 St, Malek Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9185735386
Approval date
2019-04-17, 1398/01/28
Ethics committee reference number
IR.IAU.MSHD.REC.1398.020
Health conditions studied
1
Description of health condition studied
Generalized Vitiligo vulgaris
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Score in Vasi Score
Timepoint
Before starting treatment, one-two-three month after start using drug
Method of measurement
Vasi Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: HCQ was orally administered 400 mg daily (∼6.5 mg/Kg of body weight) by 15 patients with generalized vitiligo for three months. Patients were evaluated monthly and skin re-pigmentation was assessed using the VASI SCORE.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Soudabeh Sazgarnia
Street address
Imam Reza Hospital, Imam Reza Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
soodabe.sn@gmail.com
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Soudabeh Sazgarnia
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 21 3840 0000
Email
soodabe.sn@gmail.com
3
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Soudabeh Sazgarnia
Street address
22 Bahman Hospital, Kuy-e-Tollab
City
Mashhad
Province
Razavi Khorasan
Postal code
9185735386
Phone
+98 21 3259 4345
Email
soodabe.sn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Abtahi
Street address
Imam Khomeini 14 St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 21 3620 4001
Email
soodabe.sn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Soudabeh Sazgarnia
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
2nd Floor, No. 152, Nastaran 18 St, Malek Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9185735386
Phone
+98 21 3761 5556
Email
soodabe.sn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pouran Layegh
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 52, B Bldg, Kouhsangi Residental complex, Kouhsangi 15 Alley, Kouhsangi Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176774448
Phone
+98 21 3849 4724
Email
layeghpo@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soudabeh Sazgarnia
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
2nd Floor, No. 152, Nastaran 18 St, Malek Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9185735386
Phone
+98 21 3761 5556
Email
soodabe.sn@gmail.com
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes
Under which criteria data/document could be used
Carrying out analysis on data is permitted
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month