Determination of therapeutic effects of cream containing ZAX.1400.P03 on skin inflammation caused by psoriasis
Design
The double-blindatment, and control groups in parallel, 52 patients in the drug group and 52 patients in the placebo group, for randomization we will use the permutation block method with several 6 blocks using Random allocation software.
Settings and conduct
Patients with psoriasis referred to partner medical centers are divided into two groups A and B. The anti-inflammatory effects of ZAX.1400.P03 will be evaluated. Study at the level of physician, outcome assessor, patient, and statistical analyst will be blind. Location: Fasa University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Diagnosis of the disease by a doctor 2. Age range between 18 to 60 years 3. Both sexes (male and female) 4. Having informed and written consent to participate in study 5. Only local tissue involvement and no need to use Oral medications
Conditions not included in the study: 1. Food and health allergies 2. Presence of underlying diseases and immunodeficiency 3. Pregnancy and lactation 4. Blisters and infections caused by the disease 5. Lack of consent of the physician directly responsible for the patient
Intervention groups
Dividing patients into two similar groups A and B. While receiving written consent, the treatment group in addition to the standard cream containing ZAX.1400.P03 and the control group in addition to the standard drug also uses a placebo.
Main outcome variables
VAS (Visual analogue Scale)
General information
Reason for update
Acronym
SFP
IRCT registration information
IRCT registration number:IRCT20210218050404N5
Registration date:2022-03-03, 1400/12/12
Registration timing:prospective
Last update:2022-03-03, 1400/12/12
Update count:0
Registration date
2022-03-03, 1400/12/12
Registrant information
Name
Amin Dakhili Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 9507
Email address
a.dakhili@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-05, 1400/12/14
Expected recruitment end date
2022-05-04, 1401/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of ZAX.1400.P03 on cutaneous clinical manifestations in patients with psoriasis in Fasa city in 1400
Public title
Therapeutic effects of herbs on psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the disease by a doctor
Age range between 18 and 60 years
Having informed and written consent to participate in the study
Tissue involvement only locally and no need to take oral medications
Exclusion criteria:
Food and health allergies
Existence of underlying diseases and immunodeficienc
Incidence of blisters and infections caused by the disease
Disagreement of the physician directly responsible for the patient
Pregnancy and lactation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
This study is performed on patients with psoriasis referred to the partner medical centers in the project. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease, and symptoms. B (placebo). For randomization, the permutation block method with the number of six blocks is done using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the study, after the patient enters the study, the doctor prescribes A (drug) or B (placebo) based on the randomized form. The doctor's prescription is prescribed in the same packages. Clinical caregivers are unaware of the coding assigned to each patient. The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not know about the codings. The results of the two groups under the headings of groups A and B will be submitted to the statistical analyst.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Ibn Sina square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.FUMS.REC.1400.125
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
psoriasis vulgaris
Primary outcomes
1
Description
Extent of lesion
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Relative determination of area with checkered paper
2
Description
Redness of the skin
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
3
Description
Swelling of the skin
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
4
Description
Scaling
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
5
Description
Itching
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
6
Description
skin dryness
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
7
Description
Skin irritation
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
8
Description
pain
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
9
Description
Skin scratches
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
10
Description
Skin scars
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
11
Description
Skin thickness
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
12
Description
Skin rash
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
13
Description
Recovery time
Timepoint
daily
Method of measurement
By day by checklist
Secondary outcomes
1
Description
Quality of Life
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
DLQI form
Intervention groups
1
Description
Intervention group: ZAX.1400.P03 drug composition, topical and cream-based, twice-daily use for 21 days, and patients are evaluated for up to 42 days.
Category
Treatment - Drugs
2
Description
Control group: The placebo composition, colored with food coloring, is used topically, used twice a day, for a period of 21 days, and patients are evaluated for up to 42 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamza Clinic
Full name of responsible person
Dr. Seyyed Amin Kouhpayeh
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5335 9507
Email
kouhpayeha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Yaser Mansouri
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 132 5240
Email
FUMS.mansoori@gmail.com
Web page address
https://www.fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
0715335907
Email
amindakhiliardestani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Seyyed Amin Kouhpayeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 9507
Email
kouhpayeha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
07 53359507
Email
amindakhiliardestani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Some of the information obtained will be available based on changes in initial outcomes
When the data will become available and for how long
Start of access period 6 months after production of results
To whom data/document is available
People engaged in research in medical universities of the country
Under which criteria data/document could be used
The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if the information is used.
From where data/document is obtainable
Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
What processes are involved for a request to access data/document
1. Contacting the general respondent of study 2. Sending his formal request to the respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process is 20 days.