Investigating the effectiveness of using Spark plasma alone and together with other methods in reducing skin wrinkles
Design
Factorial clinical trial without control group. No blinding on 40 samples.
Settings and conduct
After examination and formation of processing groups, cases will be processed (according to the groups) at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Exclusion criteria include the presence of active infection or history of skin cancer in the treatment area, history of keloid formation, history of hereditary or acquired connective tissue diseases, history of coagulation disorders, use of drugs involved in coagulation, having metal implants, use of "retin A" and pregnancy or breastfeeding, as well as people with skin color group V, VI, clients with artificial heart pacemakers and people under 18 years old. Also, patients who underwent cosmetic procedures around the eyes such as laser and photodynamic therapy, blepharoplasty, rhytidectomy and subcutaneous filler injections in the last 12 months were excluded from the study.
Entry criteria: Having wrinkles and sagging skin
Intervention groups
The first group: the group investigating changes in skin parameters before and after processing with spark plasma
The second group: the group investigating changes in the results in case of combining spark and argon
The third group: the group for examining the changes in the results in case of accompanying Spark and Shaver
The fourth group: the group investigating the changes in the results if spark and spray mode are combined
Main outcome variables
causing temporary inflammation and swelling in the skin of the processed area. Creating tiny burn points in the processed area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160514027888N2
Registration date:2023-02-26, 1401/12/07
Registration timing:registered_while_recruiting
Last update:2023-02-26, 1401/12/07
Update count:0
Registration date
2023-02-26, 1401/12/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 4031
Email address
m_khani@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-22, 1401/12/03
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of plasma spark with argon plasma and shower on face and neck skin rejuvenation
Public title
Investigating the effect of plasma spark with argon plasma and shower on face and neck skin rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having wrinkles and sagging skin in the desired areas
Exclusion criteria:
Presence of active infection
history of skin cancer in the treatment area
history of keloid formation
history of hereditary or acquired connective tissue diseases
history of coagulation disorders
use of drugs involved in coagulation
having metal implants
use of Retin A drug
pregnancy or breastfeeding
people with skin color group V, VI
clients with an artificial heart pacemaker
patients who underwent cosmetic procedures around the eyes such as laser and photodynamic therapy, blepharoplasty, rhytidectomy and subcutaneous filler injections in the last 12 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
40 cases divided into 4 groups (10 processing with plasma spark, 10 processing with spark and argon jet, 10 processing with spark and shower, 10 processing with 2 different spark modes) based on the random list provided by the statistical analyst (list based on blocks randomly provided) will be processed. Placing the clients in different groups and creating a random sequence was done by Random Allocation Software 2.0 for 4 groups and 40 samples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Laser and Plasma Research Institute,Shahid Beheshti University,Shahid Shahriari Square,Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.783
Health conditions studied
1
Description of health condition studied
Wrinkles and sagging skin
ICD-10 code
L98
ICD-10 code description
Other disorders of skin and subcutaneous tissue, not elsewhere classified
Primary outcomes
1
Description
Changes of collagen in the skin
Timepoint
Before starting the processes and weeks 2, 4, 6 and 10 after the processing
Method of measurement
Skin ultrasound device
2
Description
skin elasticity
Timepoint
Before starting the processes and weeks 2, 4, 6 and 10 after the processing
Method of measurement
MPA9 multifunctional device
3
Description
water evaporated from the skin surface
Timepoint
Before starting the processes and weeks 2, 4, 6 and 10 after the processing
Method of measurement
MPA9 multifunctional device
4
Description
Skin melanin changes
Timepoint
Before starting the processes and weeks 2, 4, 6 and 10 after the processing
Method of measurement
MPA9 multifunctional device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Processing only with dot mode of the Plasma Spark device
Category
Treatment - Devices
2
Description
Intervention group: Processing with the dot mode of the plasma spark device along with the argon plasma jet
Category
Treatment - Devices
3
Description
Intervention group: Processing with the dot mode of the plasma spark device along with the plasma shower
Category
Treatment - Devices
4
Description
Intervention group: Simultaneous processing with two point and spray mode of the spark plasma device
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No. 4, Maryam Ave, South Kamraniye
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 2267 1008
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
Mohammad Ali Nilforoushzadeh
Street address
No. 4, Maryam Ave, South Kamraniye
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 2267 1008
Email
nilforoosh@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy ofTehran University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mohammad Reza Khani
Street address
Evin, Shahid beheshti university
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 4017
Email
m_khani@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
50
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
Laser and Plasma Research Institute/ Shahid Beheshti University
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the project, the achievements and performance of the Spark device alone and also together with other devices and methods will be published.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions