Evaluation of safety and effectiveness of Eczacin cream made by Pharmed Salamat Sina company in improving mild and moderate atopic dermatitis in adults
Evaluation of safety and effectiveness of Eczacin cream made by Farmed Salamat Sina company in improving mild and moderate atopic dermatitis in adults
Design
It is a phase II interventional study as a non-randomized and before-after clinical study.19 adult volunteers with atopic dermatitis will participate in the study after signing informed consent.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Participants will receive Eczacin Repairing Cream, twice a day for 4 weeks on affected areas. The assessments of area, by local SCORAD (Severity Scoring of Atopic Dermatitis index) as well as skin biophysical parameters (skin hydration, trans epidermal water loss, erythema, melanin,sebum and Ph) will be performed before intervention, 2 and 4 weeks after treatment. The study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic or recurrent eczema with a mild to moderate severity and personal or family history of atopia or high IgE level, Signing the consent form for participation in the study, minimum score of one for the SCORAD scale of redness and itching
Exclusion criteria: not to use topical medications for atopic dermatitis (except for moisturizer) in the last 2 weeks or systemic medications in the last 4 weeks, Use of steroids or systemic immunosuppressive drugs with any indication, Pregnancy or lactating, Severe atopic dermatitis (SCORAD above 12)
Intervention groups
Use of Eczacin Repairing Cream made by Pharmed Salamat Sina company twice a day for 4 weeks
Main outcome variables
Local SCORAD (Severity Scoring of Atopic Dermatitis index) criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050179N2
Registration date:2021-12-09, 1400/09/18
Registration timing:registered_while_recruiting
Last update:2021-12-09, 1400/09/18
Update count:0
Registration date
2021-12-09, 1400/09/18
Registrant information
Name
Taraneh Yazdanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
drtaraneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and effectiveness of Eczacin cream made by Pharmed Salamat Sina company in improving mild and moderate atopic dermatitis in adults
Public title
Evaluation of safety and effectiveness of Eczacin cream in improving atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic or recurrent eczema with a mild to moderate severity and personal or family history of Atopia or high IgE level
Signing the consent form for participation in the study
Minimum score of one for the SCORAD (Severity Scoring of Atopic Dermatitis index) scale of redness and itching
Exclusion criteria:
Not to use topical medications for Atopic Dermatitis (except for moisturizer) in the last 2 weeks or systemic medications in the last 4 weeks. Use of steroids or systemic immunosuppressive drugs with any indication.
Pregnancy or lactating
Severe atopic dermatitis (SCORAD above 12)
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, 6th floor, Central Organization of the University, Ghods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.926
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Local SCORAD (Severity Scoring of Atopic Dermatitis index) criteria
Timepoint
Before intervention and 2 and 4 weeks after treatment
Method of measurement
Research physician will perform clinical assessments according to the local SCORAD (Severity Scoring of Atopic Dermatitis index) grade
Secondary outcomes
1
Description
Trans epidermal water loss
Timepoint
Before intervention and 2 and 4 weeks after treatment
Method of measurement
Tewameter
2
Description
stratum corneum hydration
Timepoint
Before intervention and 2 and 4 weeks after treatment
Method of measurement
Corneometer
Intervention groups
1
Description
Intervention group: Use Eczacin Repairing Cream product by Sina pharmed salamat twice a day for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy