Comparison of the safety and effectiveness of Wharton jelly mesenchymal stem cell condition medium spray and erbium laser with triamcinolone and erbium laser in the treatment of resistant hand eczema
Comparison of the safety and effectiveness of Wharton jelly mesenchymal stem cell condition medium spray and erbium laser with triamcinolone and erbium laser in the treatment of resistant hand eczema
Design
A clinical trial with a control group and an intervention group, with parallel groups, double-blind (outcome assessor and patient), randomized based on the table of random numbers, phase 1-2 on 30 patients with hand eczema
Settings and conduct
The place of study is the skin and stem cell research center clinic of Tehran University of Medical Sciences. In this study, blinding was done and the outcome assessor and the patient will not know the type of treatment. There is an intervention group and a control group. Three treatment sessions will be done with an interval of one month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy patients with hand eczema who have not used any topical medication in the past 2 weeks or any systemic medication in the past month. Exclusion criteria: pregnancy, breastfeeding, severe sensitivity to the study drug
Intervention groups
Intervention group: 10 patients are subjected to local spray of Wharton's jelly mesenchymal stem cell conditioned medium and erbium laser 3 times with an interval of 1 month. Control group: 10 patients are subjected to topical triamcinolone spray and erbium laser 3 times with an interval of 1 month.
Main outcome variables
Reduce or improve hand eczema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N26
Registration date:2023-04-21, 1402/02/01
Registration timing:prospective
Last update:2023-04-21, 1402/02/01
Update count:0
Registration date
2023-04-21, 1402/02/01
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the safety and effectiveness of Wharton jelly mesenchymal stem cell condition medium spray and erbium laser with triamcinolone and erbium laser in the treatment of resistant hand eczema
Public title
Comparison of the safety and effectiveness of local spray stem cells conditioned medium and erbium laser compared to triamcinolone and erbium laser in the treatment of hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients with hand eczema who have not used any topical medication in the past 2 weeks or any systemic medication in the past month.
Exclusion criteria:
Pregnancy
Breastfeeding
Severe sensitivity to the study drug
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that the number of cases in this research plan is 20 people, which should be randomly divided into two groups of 10 people, therefore, the randomization method in this research plan will be done in such a way that the patients will be randomly selected using the systematic randomization method and the resulting numbers. From the computer, they will be divided into two groups of 10 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the data analyst will not know the type of treatment, so the study will be conducted in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.026
Health conditions studied
1
Description of health condition studied
hand eczema
ICD-10 code
L20.8
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
Reduce or improve hand eczema
Timepoint
before and two weeks after the end of the study
Method of measurement
Using Eczema Extent and Severity Scale (EASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 patients are subjected to local spray of Wharton's jelly mesenchymal stem cell conditioned medium and erbium laser 3 times with an interval of 1 month.
Category
Treatment - Other
2
Description
Control group: 10 patients are subjected to topical triamcinolone spray and erbium laser 3 times with an interval of 1 month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem cell Research Center Clinic, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
Not applicable
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