Determination and comparison of Prosopis extract ointment with Eucerin emollient on clinical outcomes in patients with atopic dermatitis
Design
Randomized, double-blind with parallel control group clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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).
Intervention groups
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.
Main outcome variables
Eczema area and severity index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190220042770N1
Registration date:2019-03-09, 1397/12/18
Registration timing:prospective
Last update:2019-03-09, 1397/12/18
Update count:1
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Sayed Kamal Hosseinian Nodushan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 8915
Email address
sk.hosseinian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-13, 1397/12/22
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Prosopis Ointment with Eucerin Emollient on Clinical Signs of Patients with Atopic Dermatitis
Public title
Effect of Prosopis Ointment in Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
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)
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
SEthics committee of Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi Blvd., Central Office of the University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8951737915
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.SSU.REC.1397.154
Health conditions studied
1
Description of health condition studied
Atopic Dermatitis
ICD-10 code
L20.9
ICD-10 code description
Atopic dermatitis, unspecified
Primary outcomes
1
Description
Eczema area and Severity index
Timepoint
Before starting treatment and ending weeks 1 and 3 and 6
Method of measurement
EASI Questionnaire for Atopic Dermatitis
Secondary outcomes
1
Description
Erythema
Timepoint
Before starting treatment and week 1, 3 and 6
Method of measurement
EASI Questionnaire for Atopic Dermatitis
2
Description
Tickness
Timepoint
Before starting treatment and week 1, 3 and 6
Method of measurement
EASI Questionnaire for Atopic Dermatitis
3
Description
Scratching or Excoriation
Timepoint
Before starting treatment and week 1, 3 and 6
Method of measurement
EASI Questionnaire for Atopic Dermatitis
4
Description
Lichenification
Timepoint
Before starting treatment and week 1, 3 and 6
Method of measurement
EASI Questionnaire for Atopic Dermatitis
Intervention groups
1
Description
Intervention group: Prosopis ointment twice a day for 14 days
Category
Treatment - Drugs
2
Description
Control group: Eucerin twice a day for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Shahid Baghei Pour Clinic
Full name of responsible person
Seyed Kamal Hosseinian Nodushan
Street address
Central office of Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
sk.hosseinian@mail.ssu.ac.ir
Web page address
http://ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzae
Street address
Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3726 3154
Email
info@ssu.ac.ir
Web page address
http://web.ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayed Kamal Hosseinian Nodushan
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 1, Etehadie Alley, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3733 0122
Email
sk.hosseinian@mail.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Majid Emtiazy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3223 8915
Email
dr.emtiazy@yahoo.com
Web page address
http://ssu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayed Kamal Hosseinian nodushan
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8951737915
Phone
+98 35 3821 7545
Email
shkamalreza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available