Effectiveness of zinc supplementation on clinical signs
(severity of itching, erythem, scaling, induration and surface area of plaques) of patients with plaque type psoriasis with skin involvement under 20%.
Design
In this Clinical Trial estimated number of patients is 40 that they will be classified with simple randomization method in 2 groups of intervention and control group each include 20 patients and these 2 parallel groups will enter phase 3rd of trial with double blinded method.
Settings and conduct
About 100 of patients who refer to the Dermatology Clinic of Ardabil Imam Reza Hospital will be sent for screening of serum zinc level and patients who has serum zinc deficiency will enter the Clinical Trial. At first a list of clinical signs of every patient will record then the patients will be classified in 2 groups of Intervention and Control group with simple randomization method. During the intervention period all patients of both group will be followed up about changes in clinical signs every two weeks and after intervention period, they will be followed up every month till 3 month. Also during the intervention both patients and researchers (dermatologist and student) will be blind of medication the patients take ( zinc supplement or placebo).
Participants/Inclusion and exclusion criteria
Entrance: Patients with Plaque Type Psoriasis with skin involvement under 20% , Serum Zinc Deficiency; Exit: Patients with Gastrointestinal problems.
Intervention groups
Intervention group will receive 220 mg zinc sulfate supplement once daily with topical urea eucerine emollient cream 3 times a day for 1 month and Control group will receive placebo once daily with topical urea eucerine emollient cream 3 times a day for 1 month.
Main outcome variables
severity of itching, erythema , scaling, body surface area and induration of plaques
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045186N1
Registration date:2019-12-02, 1398/09/11
Registration timing:retrospective
Last update:2019-12-02, 1398/09/11
Update count:0
Registration date
2019-12-02, 1398/09/11
Registrant information
Name
Romina Behboudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 0045
Email address
r.behboudi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Zinc Supplementation on Clinical Signs of Plaque Type Psoriasis Patients with Skin Involvement Under 20%
Public title
Effect of Zinc in treatment of Psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Plaque Type Psoriasis Patients with Skin Involvement Under 20% with Serum Zinc Defficiency
Exclusion criteria:
Patients with Gastrointestinal Problems and Malabsorption Syndrome
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization
Randomization Schedule: Random Number Table
Randomization Unit: Individual ( student and dermatologist)
Blinding (investigator's opinion)
Double blinded
Blinding description
In this process patients, researchers ( medical student and the dermatologist doctor) and evaluators of consequence ( patients themselves, medical student and dermatologist ) are blind and none of them doesn't know which medication the patients are taking (zinc supplement or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Square, Daneshgah Avenue, Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.ARUMS.REC.1398.382
Health conditions studied
1
Description of health condition studied
Plaque Type Psoriasis with Skin Involvement Under 20%
ICD-10 code
L41.3
ICD-10 code description
Small plaque parapsoriasis
Primary outcomes
1
Description
Difference in itching of plaques
Timepoint
Before intervention, 14, 30, 60, 90, 120 days after intervention
Method of measurement
Severity mentioned by patient according to BSA and PASI indexes
2
Description
Difference in erythem of plaques
Timepoint
Before intervention, 14, 30, 60, 90, 120 days after intervention
Method of measurement
Severity mentioned by patient according to BSA and PASI indexes
3
Description
Difference in scaling of plaques
Timepoint
Before intervention, 14, 30, 60, 90, 120 days after intervention
Method of measurement
Severity mentioned by patient according to BSA and PASI indexes
4
Description
Difference in surface area of plaques
Timepoint
Before intervention, 14, 30, 60, 90, 120 days after intervention
Method of measurement
Severity mentioned by patient according to BSA and PASI indexes
5
Description
Difference in induration of plaques
Timepoint
Before intervention, 14, 30, 60, 90, 120 days after intervention
Method of measurement
Severity mentioned by patient according to BSA and PASI indexes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will take 220mg zinc sulfate capsule once daily with topical urea eucerine emollient cream three times a day on plaques till one month.
Category
Treatment - Drugs
2
Description
Control group: The control group will take placebo once daily with topical urea eucerine emollient cream three times a day on plaques till one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Emam Reza Hospital
Full name of responsible person
Dr Majid Rostami Moghaddam
Street address
Near to Islamic Azad University of Ardabil, Basij Square, Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3081
Email
e-reza@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Hale Valizadeh Haghghi
Street address
Ardabil University of Medical Sciences, Daneshgah Square, Daneshgah Avenue, Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4790
Email
info@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?