Determining and comparing the effects of topical atorvastatin and rosuvastatin on skin plaques of patients with psoriasis in Shahada Mehrab Hospital, Yazd.
Design
A clinical trial with a control group, with parallel groups, double-blind, phase 2 on 60 patients with psoriasis that affects less than 20% of their body surface.Psoriatic patients with plaque size larger than 2cm*2cm and size less than 15cm*15cm/patients will be randomized according to the random numbers table to receive one of the interventions of Atorvastatin or Rosuvastatin creams or basic cream (20 people in each group).
Settings and conduct
Psoriasis patients referring to the outpatient dermatology clinic of Shahada Mehrab Hospital, Yazd, undergo a four-week wash-out period from any topical products related to psoriasis before entering the study. In addition, systemic treatments, including phototherapy, will be stopped four weeks before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with psoriasis that affects less than 20% of the body surface/age over 18 years/referring to the outpatient skin clinic of Shahada Mehrab Hospital
Exclusion criteria: pregnant or lactating women/patients suffering from several skin diseases at the same time/patients using non-steroidal anti-inflammatory drugs daily or more than 5 times a week/Known sensitivity to ointment components
Intervention groups
The first group received the standard treatment along with the topical form of atorvastatin, and the second and third groups respectively received the standard treatment along with the topical form of rosovastatin and the standard treatment along with the base cream without the active ingredient.
Main outcome variables
Determining the severity of the disease based on the Psoriasis Area Severity Index (PASI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240220061059N1
Registration date:2024-08-12, 1403/05/22
Registration timing:registered_while_recruiting
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Golnaz Afzal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 7246
Email address
g.afzal@ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation & evaluation of atorvastatin & rosuvastatin creams & comparison of their clinical effects on the psoriatic patients
Public title
Comparison of the clinical effect of atorvastatin ointment with rosuvastatin in patients with psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
over 18 years old
Psoriasis patients referred to the skin outpatient clinic of Shahada Mehrab Hospital
Exclusion criteria:
pregnancy or lactation
Patients suffering from several skin diseases at the same time
Patients using non-steroidal anti-inflammatory drugs daily or more than 5 times a week
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the permutation block method, patients are entered in three groups of 20 people with atorvastatin, rosuvastatin and base cream without active ingredient. The number of 10 blocks of 6 is considered.The generation of random codes will be generated using random allocation using the permutation block method with the help of Random allocation software version 1. The first eligible person to enter the study is given number one and so on until the last eligible person is given number 60. Using the table generated by the random allocation software, according to the number, the intervention people (A or B or C) each of the letters A, B and C will be installed on containers of the same shape and will be assigned to one of the interventions. receive In order to hide the random allocation, this list will be given to another person outside the study, and before assigning the type of treatment, they will be asked according to the number of the eligible person, and in this way, the people will enter the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the above steps will be hidden from the sight of the patient and the attending physician. In this way, the first executor determines the sequence of assigning people according to the order in which patients enter the study, and pours the ointments into envelopes of the same shape for the patient's use and designates them with A, B, or C codes. Then, according to the above description, he selects the appropriate medicines for each person and puts them in special envelopes and delivers them to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
central organization of Shahid Sadoughi university of medical science, Shahid Bahonar square, Yazd Town
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2023-01-11, 1401/10/21
Ethics committee reference number
IR.SSU.MEDICINE.REC.1401.191
Health conditions studied
1
Description of health condition studied
Psoriasis skin disease
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
Primary outcome of disease severity based on Psoriasis Area Severity Index (PASI)
Timepoint
The measurement of the primary outcome variable is based on time intervals 0, and in weeks 4, 8, and 12 after the start of the intervention.
Method of measurement
The primary outcome variable is evaluated using the Psoriasis Area Severity Index criterion, which ranges from 0 to 72. The effectiveness of the treatment is in the form of changes in the PASI criterion from baseline to the last week. A complete response is when the PASI standard decreases to zero in the last week, a marked response is when the PASI standard is reduced by more than 75% from the baseline, a moderate response is when the standard PASI should decrease between 50 and 74%; A slight response is when the PASI score decreases by less than 50%. No response is when the lesions do not change during twelve weeks of treatment
Secondary outcomes
1
Description
The secondary outcome is that at the beginning of visiting the clinic and entering the study, and at the end of the twelfth week, a photo of the lesions is taken, and the degree of improvement in the lesions is scored from zero to ten through a visual analog scale. (zero for lesions that have not improved at all and ten for the best response to treatment)
Timepoint
At the beginning of the study and at the end of the twelfth week after the start of the intervention, the secondary outcome is evaluated
Method of measurement
The rate of recovery in the process of lesions through visual analog scale
Intervention groups
1
Description
The first group will receive the standard treatment in addition to the topical form of atorvastatin made by the researcher, and the second group will receive the standard treatment in addition to the topical form of rosuvastatin made by the researcher. Use your index finger along the length of the last part to create a thin layer on the surface of the skin. After using the cream, patients are asked to wait for at least ten minutes before putting on clothes and not to wash the area after using the cream for at least two hours.
Category
Treatment - Drugs
2
Description
Control group: The third group (control group) will receive the standard treatment along with the base cream without the active ingredient. Patients are taught to use the cream of their treatment branch twice a day, the length of the last part of their index finger, so that a thin layer is created on the surface of the skin. After using the cream, patients are asked to wait for at least ten minutes before putting on clothes and not to wash the area after using the cream for at least two hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient Dermatology Clinic of Yazd Mehrab Martyrs Hospital
Full name of responsible person
Narges Ghaneei
Street address
Moalem intersection, Yazd Town
City
yazd
Province
Yazd
Postal code
۱۴۳۹۹۱۴۱۵۳
Phone
+98 35 3525 0094
Email
dr.golnaz.afzal@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghoee
Street address
Research and Technology Vice-Chancellor, Imam Reza (AS) Educational Complex , Student Blvd,Imam Hossein (AS) Square, Yazd Town
City
Yazd
Province
Yazd
Postal code
٨٩١٦١٨٨٦٣٧
Phone
+98 35 3628 8114
Email
m.gmail@editormshsj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Professor Assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 3865
Email
dr.golnaz.afzal@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 3865
Email
dr.golnaz.afzal@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 3865
Email
dr.golnaz.afzal@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
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
The data collected from the samples in line with the special objectives of the study
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
Faculty members of Iran Universities of Medical Sciences, Faculty of Pharmacy
Under which criteria data/document could be used
They are only allowed to perform new analyzes that improve the status of the results
From where data/document is obtainable
By introducing yourself and your request via email to the corresponding author
What processes are involved for a request to access data/document