Comparison of the effect of fluocinolone drug with oral atorvastatin with fluocinolone alone on the treatment of patients with vitiligo
Design
A clinical trial with a control group, with parallel groups, one-way blind, randomized, on 40 patients (2 groups of 20 people). Excel software rand function was used for randomization.
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 10 units of 4 blocks will be selected so that we consider having 20 people in the group (A) and 20 people in the group (B). Therefore, we will do block randomization.
Settings and conduct
Kowsar Hospital Clinic.
Given that patients are coded by the clinical caregiver. Researchers are unaware of the type of grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-60 years; Infection of less than 20% of the body surface with vitiligo; Vitiligo over the past year.
Exclusion criteria: Pregnant or lactating woman; With systemic and metabolic diseases (diabetes, thyroid diseases, etc.).
Intervention groups
Intervention group: Patients receive topical (fluocinolone ointment 0.025% - Darupakhsh Company) twice daily for 12 weeks. They also take atorvastatin 20 mg tablets(Rosdaro Company) for 12 weeks (one tablet daily for the first month and two tablets daily for the second month).
Control group: Patients receive routine treatment (fluocinolone ointment %0.025 - Darupakhsh Company) topical for 12 weeks and twice a day.
Main outcome variables
The severity of the disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N64
Registration date:2021-02-12, 1399/11/24
Registration timing:registered_while_recruiting
Last update:2021-02-12, 1399/11/24
Update count:0
Registration date
2021-02-12, 1399/11/24
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fluocinolone drug with oral atorvastatin with fluocinolone alone on the treatment of patients with vitiligo
Public title
Comparison of the effect of fluocinolone drug with oral atorvastatin on the treatment of patients with vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Infection of less than 20% of the body surface with vitiligo
Vitiligo over the past year
Exclusion criteria:
Pregnant or lactating woman
With systemic and metabolic diseases (diabetes, thyroid diseases, etc.)
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 10 units of 4 blocks will be selected so that we consider having 20 people in the group (A) and 20 people in the group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that patients are coded by the clinical caregiver. researchers are unaware of the type of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SEMUMS.REC.1399.165
Health conditions studied
1
Description of health condition studied
Vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
The severity of the disease
Timepoint
Before intervention, 1 and 2 months after intervention
Method of measurement
Scoring using the vitiligo area severity index (VASI) and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients receive routine treatment (fluocinolone ointment %0.025 - Darupakhsh Company) topical for 12 weeks and twice a day.
Category
Diagnosis
2
Description
Intervention group: Patients receive topical (fluocinolone ointment 0.025% - Darupakhsh Company) twice daily for 12 weeks. They also take atorvastatin 20 mg tablets(Rosdaro Company) for 12 weeks (one tablet daily for the first month and two tablets daily for the second month).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Maryam Azizzadeh
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaie
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Maryam Azizzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Skin and hair
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Azizzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Skin and hair
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Azizzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Skin and hair
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available