Protocol summary
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Study aim
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To assess the effect of topical oatmeal cream versus topical placebo cream on the treatment of chronic eczema of the hand
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Design
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This is a double-blind randomized clinical trial, phase II, in which 70 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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Setting and conduct: The eligible patients with chronic eczema of the hand who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that the shape of the two types of cream will be similar and patients will not be aware of the type of cream they use. In addition, the assignment of the patients to the intervention and control groups will be done by a third person, therefore, the physician who will examine the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 12 to 65 years;
Chronic eczema of the hand
Exclusion criteria:
Pregnancy or breastfeeding;
Other concurrent skin lesions such as psoriasis;
Immunodeficiency
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Intervention groups
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Intervention group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks
Control group: Topical Fluocinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
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Main outcome variables
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Primary outcome:
The severity of pruritus,
The severity of skin lesions
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N257
Registration date:
2019-01-13, 1397/10/23
Registration timing:
registered_while_recruiting
Last update:
2019-11-28, 1398/09/07
Update count:
1
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Registration date
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2019-01-13, 1397/10/23
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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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2018-12-31, 1397/10/10
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Expected recruitment end date
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2019-06-21, 1398/03/31
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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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Effect of topical N-acetyl cysteine cream versus topical corticosteroid on treatment of chronic eczema of the hand: a double-blind randomized clinical trial
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Public title
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Effect of topical N-acetyl cysteine cream versus topical corticosteroid on treatment of chronic eczema of the hand
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 12 to 65 years;
Chronic eczema of the hand
Exclusion criteria:
Pregnancy or breastfeeding;
Other concurrent skin lesions such as psoriasis;
Immunodeficiency
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Age
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From 12 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The shape of the medications will be perfectly the same in the two groups. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-01, 1397/06/10
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Ethics committee reference number
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IR.UMSHA.REC.1397.398
Health conditions studied
1
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Description of health condition studied
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Eczema
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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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The severity of pruritus
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Timepoint
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Before the intervention and 2 and 6 weeks after the intervention
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Method of measurement
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By taking history
2
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Description
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The severity of skin lesions
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Timepoint
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Before the intervention and 2 and 6 weeks after the intervention
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Method of measurement
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By clinical examination
Intervention groups
1
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Description
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Intervention group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical oatmeal cream 1% (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical oatmeal cream 1% alone for 4 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Topical Flucinolone cream 25% (Manufactured by Behvarzan Pharmaceutical Company) plus topical placebo cream (Manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) for 2 weeks and then topical placebo cream alone for 4 weeks
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Category
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Placebo
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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Hamedan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available