Protocol summary
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Study aim
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Determine the effectiveness of whey protein in improving the symptoms of patients with contact dermatitis
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Design
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A randomized double blind placebo - control clinical trial
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Settings and conduct
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60 patients over 5 years of age with Contact dermatitis referred to the clinics of Shiraz University of Medical Sciences will be studied,divided into two groups of 30 patients treated with drug and placebo. Patients will receive 30 grams of whey protein powder per day. During the intervention, the examination and the questionnaire (SCORAD and DLQ index (dermatology life quality index)) will be performed at the beginning of the treatment also in the second week and 4th week and the results will be reviewed.
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Participants/Inclusion and exclusion criteria
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Age over 5 years
Contact dermatitis(clinical or with patch test)
Cows milk allergy
Pregnancy or severe disease as malignancy
Patients who had a new treatment or an increase in the dose within 4 weeks prior to the intervention
Patients treated with immunosuppressive drugs
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Intervention groups
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Patients will receive 30 grams of powder per day from reputable pharmaceutical companies.During the intervention, the examination and the questionnaire (SCORAD and DLQ index (dermatology life quality index)) will be performed at the beginning of the treatment also in the second week and 4th week and the results will be reviewed.
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Main outcome variables
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Determine the effectiveness of whey protein in improving the symptoms of patients with contact dermatitis including control of cutaneous dryness, itching, erythema, swelling, eczema and lichenification.
General information
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Reason for update
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Modify the start and end dates of patient admissions
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190202042587N1
Registration date:
2019-03-03, 1397/12/12
Registration timing:
prospective
Last update:
2020-08-09, 1399/05/19
Update count:
2
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Registration date
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2019-03-03, 1397/12/12
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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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2019-03-06, 1397/12/15
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Expected recruitment end date
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2020-02-20, 1398/12/01
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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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Evaluation of efficacy of whey protein in improving the symptoms of patients with contact dermatitis: A randomized double blind placebo, control clinical trial
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Public title
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Evaluation of efficacy of whey protein in contact dermatitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 5 years
Contact dermatitis(clinical or with patch test)
Exclusion criteria:
Cows milk allergy
Pregnancy or severe disease as malignancy
Patients who had a new treatment or an increase in the dose within 4 weeks prior to the intervention
Patients treated with immunosuppressive drugs
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Age
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From 5 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The study will be blind for patient, outcome assessor and statistical analyzer. Drug and placebo bottles before filling in according to the randomized block table are divided into two equal groups of 30 digits and then, based on the results, bottles are filled with drugs or placebo. The only researcher based on the primary form of the stored results can decode the content of each bottle.
None of the responsible person will be aware of the encoding. Results of control and intervention groups under the heading of group A and B delivered to the statistical analyst.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patient, outcome assessor and statistical analyzer
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Placebo
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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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2018-12-19, 1397/09/28
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.383
Health conditions studied
1
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Description of health condition studied
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Contact dermatitis
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ICD-10 code
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L25
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ICD-10 code description
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Unspecified contact dermatitis
Primary outcomes
1
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Description
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Reduced scores in questionnaire and during periodic examination, which indicate better control of the disease and reduced symptoms
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Timepoint
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At the beginning of the study, 14 and 28 days after starting the drug
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Method of measurement
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Questionnaire including EASI (eczema area and severity index) and VAS (visual analog scale) and DLQ index (dermatology life quality index)
Intervention groups
1
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Description
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Intervention group: Patients will receive 30 grams of powder per day, orally, from reputable pharmaceutical companies(half the dose in children) divided into two equal doses.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients will receive 30 grams of placebo per day (half the dose in children), divided into two equal doses, orally.The placebo is made up of 6-1-1 from corn starch, corn flour and lactose which is very similar to Whey in smell and taste and lacks harmful effects.
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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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Shiraz 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