Protocol summary
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Study aim
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Determination and comparison of Prosopis extract ointment with Eucerin emollient on clinical outcomes in patients with atopic dermatitis
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Design
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Randomized, double-blind with parallel control group clinical trial
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Settings and conduct
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Patients with atopic dermatitis referring to Shahid Bagheypour skin clinic are given cream Prosopis (A) or Eucerin emollient (B). The patients are not aware of the type of drug they are assigned to. The groups were also coded A and B to the statistical analyzer.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the study include: patients with typical atopic dermatitis are mild to moderate and exclusion criteria include: patients with psoriasis; any allergy to the ointment provided; bacterial infection or synchronous systemic disease (except asthma and allergic rhinitis).
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Intervention groups
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Intervention group: use of topical product of Prosopis Ointment 3% 1FTU (finger tip unit) twice daily for a palm of the body for 6 weeks.
Control group: use of topical Eucerin Softener 1FTU (finger tip unit) twice daily for 6 weeks.
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Main outcome variables
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Eczema area and severity index
General information
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Reason for update
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End of getting pationts and end of project
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190220042770N1
Registration date:
2019-03-09, 1397/12/18
Registration timing:
prospective
Last update:
2020-08-04, 1399/05/14
Update count:
1
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Registration date
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2019-03-09, 1397/12/18
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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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2019-03-13, 1397/12/22
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Expected recruitment end date
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2019-06-05, 1398/03/15
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Actual recruitment start date
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2019-03-16, 1397/12/25
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Actual recruitment end date
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2019-09-24, 1398/07/02
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Trial completion date
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2019-11-04, 1398/08/13
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Scientific title
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Comparison of the Effect of Prosopis Ointment with Eucerin Emollient on Clinical Signs of Patients with Atopic Dermatitis
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Public title
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Effect of Prosopis Ointment in Dermatitis
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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 Typical lesions of Mild to Moderate Atopic Dermatitis
Exclusion criteria:
Patients with Psoriasis
Sensitivity to Ointment
Concurrent Bacterial infection or Systemic disease (except Asthma and Allergic Rhinitis)
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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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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
44
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study was designed simple randomization method using random numbers table.
The ointments are coded by the statistic consultant (a and b), the researcher, physicians, and patients do not know the contents of ointment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients will be randomized (black design) in two groups treated with ointment prepared from the Herb extract and Emollient. Ointments are identical in appearance and aroma, coding and labeling are protected in a computer program.
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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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2019-01-22, 1397/11/02
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Ethics committee reference number
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IR.SSU.REC.1397.154
Health conditions studied
1
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Description of health condition studied
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Atopic Dermatitis
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ICD-10 code
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L20.9
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ICD-10 code description
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Atopic dermatitis, unspecified
Primary outcomes
1
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Description
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Eczema area and Severity index
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Timepoint
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Before starting treatment and ending weeks 1 and 3 and 6
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Method of measurement
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EASI Questionnaire for Atopic Dermatitis
Secondary outcomes
1
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Description
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Erythema
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Timepoint
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Before starting treatment and week 1, 3 and 6
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Method of measurement
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EASI Questionnaire for Atopic Dermatitis
2
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Description
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Tickness
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Timepoint
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Before starting treatment and week 1, 3 and 6
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Method of measurement
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EASI Questionnaire for Atopic Dermatitis
3
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Description
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Scratching or Excoriation
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Timepoint
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Before starting treatment and week 1, 3 and 6
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Method of measurement
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EASI Questionnaire for Atopic Dermatitis
4
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Description
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Lichenification
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Timepoint
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Before starting treatment and week 1, 3 and 6
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Method of measurement
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EASI Questionnaire for Atopic Dermatitis
Intervention groups
1
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Description
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Intervention group: Prosopis ointment twice a day for 14 days
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Category
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Treatment - Drugs
2
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Description
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Control group: Eucerin twice a day for 14 days
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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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Yazd 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