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The effect of Cream Containing Date Extract in the Treatment of Patients with Eczema

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History
# Registration date Revision Id
2 2023-12-30, 1402/10/09 290133
1 2022-05-23, 1401/03/02 227352
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  • General information

    2023-02-20, 1401/12/01
    2025-03-18, 1403/12/28
    empty
    More time is needed to check the stability of the formulation. Also, clinical studies require more time for eczema patients to refer to the skin center.
    empty
    زمان بیشتری برای بررسی پایداری فرمولاسیون مورد نیاز هست. همچنین مطالعات بالینی نیاز به زمان بیشتر برای مراجعه بیماران دچار اگزما به مرکز پوست دارد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Dermatology and Leprosy Research Center of Tehran University of Medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقات پوست و جذام دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Soamyeh Handali
    Full name of responsible person - Persian: سمیه هندالی
    Street address - English: Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
    Street address - Persian: تهران. انقلاب -خ پورسینا
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۷۶۱۴۴۱۱
    Phone: +98 21 6412 1510
    Fax:
    Email: s-handali@sina.tums.ac.ir
    Web page address:
    Name of recruitment center - English: Dermatology and Leprosy Research Center of Tehran University of Medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقات پوست و جذام دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Soamyeh Handali
    Full name of responsible person - Persian: سمیه هندالی
    Street address - English: Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
    Street address - Persian: تهران، میدان انقلاب ، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۷۶۱۴۴۱۱
    Phone: +98 21 6412 1510
    Fax:
    Email: s-handali@sina.tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Somayeh Handali
    Full name of responsible person - Persian: سمیه هندالی
    Street address - English: , Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
    Street address - Persian: تهران-امقلاب -خ پورسینا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۷۶۱۴۴۱۱
    Phone: +98 21 6412 1510
    Fax:
    Email: s-handali@sina.tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Somayeh Handali
    Full name of responsible person - Persian: سمیه هندالی
    Street address - English: , Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
    Street address - Persian: تهران، میدان انقلاب ، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۱۷۶۱۴۴۱۱
    Phone: +98 21 6412 1510
    Fax:
    Email: s-handali@sina.tums.ac.ir
    Web page address:

Protocol summary

Study aim
The aim of this study is to treat eczema using a cream formulation containing date extract.
Design
The clinical trial has a control group and a patient group and over 50 patients.
Settings and conduct
The study site is the Dermatology and Leprosy Research Center of Tehran University of Medical Sciences. All patients use a cream containing date extract for 4 weeks. The cream is used daily in patients / twice a day, each time they should use the cream on the entire surface of skin lesions.
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients with mild to moderate eczema. Conditions not included in the study, patients with underlying diseases.
Intervention groups
The intervention groups are patients and the control groups. Patient groups will use a cream formulation containing date extract daily / twice a day. Control groups will also receive standard treatments for eczema.
Main outcome variables
Itching rate; skin inflammation

General information

Reason for update
More time is needed to check the stability of the formulation. Also, clinical studies require more time for eczema patients to refer to the skin center.
Acronym
IRCT registration information
IRCT registration number: IRCT20211127053186N1
Registration date: 2022-05-23, 1401/03/02
Registration timing: registered_while_recruiting

Last update: 2023-12-30, 1402/10/09
Update count: 1
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Somayeh Handali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1510
Email address
s-handali@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cream Containing Date Extract in the Treatment of Patients with Eczema
Public title
"Evaluation of the Effect of Date Cream in the Treatment of Eczema"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate eczema may be eligible for admission
Exclusion criteria:
People who have underlying diseases. People who very old and difficult to get information from them.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NO

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
thics committee of Tehran Medical University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Approval date
2021-11-06, 1400/08/15
Ethics committee reference number
IR.TUMS.TIPS.REC.1400.147

Health conditions studied

1

Description of health condition studied
Eczema disease
ICD-10 code
L20.84
ICD-10 code description
Intrinsic (allergic) eczema

Primary outcomes

1

Description
"itching rate"
Timepoint
Periods include assessing the amount of pruritus before and after treatment for two weeks.
Method of measurement
standard skin questionnaire

2

Description
the rate of inflammation
Timepoint
Periods include assessing the extent of inflammation before and after treatment for two weeks.
Method of measurement
a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
This cream will be prepared by Tarbiat Modares University. Intervention group (patients with mild or moderate eczema): Cream containing date extract will be used to control and treat eczema. All patients use a cream containing date extract for 4 weeks. Use the cream daily / twice a day, each time you should use the cream on the entire surface of skin lesions. The cream contains date extract, Stearic acid, Spermaceti, Glycerin, Benzyl alcohol and Cetyl alcohol.
Category
Treatment - Drugs

2

Description
Control group: standard treatments will be used. The standard treatment for eczema is topical corticosteroids such as Triamcinolone twice daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatology and Leprosy Research Center of Tehran University of Medical Sciences
Full name of responsible person
Soamyeh Handali
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 1510
Email
s-handali@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Handali
Street address
, Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 1510
Email
s-handali@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Handali
Position
University faculty
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 1510
Email
s-handali@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Handali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Assistant Professor
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 1510
Email
s-handali@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Somayeh Handali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 1510
Email
s-handali@sina.tums.ac.ir

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
Publication of results after the end of the study
When the data will become available and for how long
After the end of the study
To whom data/document is available
All people
Under which criteria data/document could be used
These data will be available to all groups to know the effectiveness of the cream formulation containing date extract in the treatment of eczema.
From where data/document is obtainable
School of Pharmacy and Dermatology and Leprosy Research Center, Tehran University of Medical Sciences Somayeh Handali 09161147998 handali_s81@yahoo.com
What processes are involved for a request to access data/document
Search in the internet for accessing results
Comments
NO
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