Protocol summary
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Study aim
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The aim of this study is to treat eczema using a cream formulation containing date extract.
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Design
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The clinical trial has a control group and a patient group and over 50 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria for patients with mild to moderate eczema.
Conditions not included in the study, patients with underlying diseases.
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Intervention groups
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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.
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Main outcome variables
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Itching rate; skin inflammation
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-05-23, 1401/03/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-20, 1400/12/01
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Expected recruitment end date
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2025-03-18, 1403/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Cream Containing Date Extract in the Treatment of Patients with Eczema
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Public title
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"Evaluation of the Effect of Date Cream in the Treatment of Eczema"
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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NO
Ethics committees
1
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Ethics committee
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Approval date
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2021-11-06, 1400/08/15
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1400.147
Health conditions studied
1
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Description of health condition studied
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Eczema disease
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ICD-10 code
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L20.84
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ICD-10 code description
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Intrinsic (allergic) eczema
Primary outcomes
1
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Description
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"itching rate"
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Timepoint
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Periods include assessing the amount of pruritus before and after treatment for two weeks.
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Method of measurement
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standard skin questionnaire
2
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Description
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the rate of inflammation
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Timepoint
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Periods include assessing the extent of inflammation before and after treatment for two weeks.
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Method of measurement
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a questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: standard treatments will be used. The standard treatment for eczema is topical corticosteroids such as Triamcinolone twice daily
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Publication of results after the end of the study
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When the data will become available and for how long
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After the end of the study
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To whom data/document is available
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All people
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Under which criteria data/document could be used
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These data will be available to all groups to know the effectiveness of the cream formulation containing date extract in the treatment of eczema.
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From where data/document is obtainable
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School of Pharmacy and Dermatology and Leprosy Research Center, Tehran University of Medical Sciences
Somayeh Handali
09161147998
handali_s81@yahoo.com
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What processes are involved for a request to access data/document
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Search in the internet for accessing results
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Comments
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NO