Determination of the anti-inflammatory effect of ZAX.1400.EC.02 on the course of the disease and symptomatic treatment of eczema
Design
In the double-blind clinical trial, two treatment, and control groups in parallel, 60 patients in the drug group and 50 patients in the control group, for randomization we will use the permutation block method with a number of 6 blocks using Random allocation software.
Settings and conduct
Patients with eczema referred to partner medical centers are divided into two groups A and B. The anti-inflammatory effects of ZAX.1400.EC.02 will be evaluated. Study at the level of the physician, clinical caregiver, 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 physician 2. Both sexes (male and female) 3. Having informed and written consent to participate in the study
Conditions for not entering the study: 1. The disagreement of the physician directly responsible for the patient 2. Allergy to food and health 3. Pregnancy and lactation 4. Blisters and infection caused by the disease
Intervention groups
Dividing patients into two similar groups A and B. While receiving written consent, the treatment group in addition to the standard ointment containing ZAX.1400.EC.02 and the control group uses only the standard drug.
Main outcome variables
VAS (Visual analogue Scale)
General information
Reason for update
Acronym
SFE
IRCT registration information
IRCT registration number:IRCT20210218050404N3
Registration date:2022-02-14, 1400/11/25
Registration timing:prospective
Last update:2022-02-14, 1400/11/25
Update count:0
Registration date
2022-02-14, 1400/11/25
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
2022-04-13, 1401/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-inflammatory effects of ZAX.1400.EC.02 drug on skin inflammation in patients with eczema
Public title
Therapeutic effects of herbs on eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the disease by a doctor
Both sexes (male and female)
Having informed and written consent to participate in the study
Exclusion criteria:
Pregnancy and lactation
Food and health allergies
بروز تاول و عفونت ناشی از بیماری
Disagreement of the physician directly responsible for the patient
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:
110
Randomization (investigator's opinion)
Randomized
Randomization description
This study is performed on patients with eczema 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, and randomly, using the patient code numbers, one group is group A (herbal medicine) and one group is group B (standard medicine). 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.1400.124
Health conditions studied
1
Description of health condition studied
Eczema
ICD-10 code
L23.9
ICD-10 code description
Allergic contact dermatitis, unspecified cause
Primary outcomes
1
Description
Extent of lesion
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Determine the area in CM2
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
VAS 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
Skin scratches
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
9
Description
Skin scars
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
10
Description
Skin thickness
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
11
Description
Skin rash
Timepoint
In seven turns; Days zero, 7, 14, 21, 28, 35 and 42
Method of measurement
Visual Analogue Scale checklist
12
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.EC.02 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: Betamethasone is used topically, twice daily, for 21 days, and patients are evaluated for up to 42 days.
Category
Treatment - Drugs
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
کارشناس
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
دانشیار
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
+98 71 5335 9507
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
No - There is not a plan to make this available
Analytic Code
No - There is not 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.