Investigating the Effectiveness of Radiofrequency-Assisted Subcision Treatment Compared to Combined Platelet-Rich Plasma (PRP) and Radiofrequency-Assisted Subcision Treatment on Scars Left by Acne Vulgaris
Investigating the Effectiveness of Radiofrequency-Assisted Subcision Treatment Compared to Combined Platelet-Rich Plasma (PRP) and Radiofrequency-Assisted Subcision Treatment on Scars Left by Acne Vulgaris
Design
This Study Is About People Who Suffer from Atrophic Type of Acne Scars. The Sample of the Study Was 10 People Who Referred to the Skin Clinic. These People Must be Over 18 Years Old and Have Mild to Moderate Atrophic Scars.
Settings and conduct
After Entering the Study, Patients Referred to Afzalipour Kerman Clinic, based on the type and Grading of Scars, Undergo a Session Of RF-Subcision Treatment on Both Sides of The Face and PRP Treatment on One Side of The Face
Participants/Inclusion and exclusion criteria
Inclusion Criteria: People Must be Over 18 Years Old and Have Mild to Moderate Atrophic Scars
Exit Criteria: 1-People with Underlying Diseases Such as Cardiac Pacemakers, Metal Implants Inside the Body
2- People with Active Acne Lesions or Infection on Scar Lesions
3- People Who Have Benefited from Other Scar Improvement Treatments Such as Laser, Physical and Chemical Exfoliation in The Last 4 Months
Intervention groups
10 People Who Refer to The Skin Clinic Should Be Over 18 Years Old and Have Mild to Moderate Atrophic Scars.
Main outcome variables
Acne Treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221110056463N1
Registration date:2023-06-10, 1402/03/20
Registration timing:registered_while_recruiting
Last update:2023-06-10, 1402/03/20
Update count:0
Registration date
2023-06-10, 1402/03/20
Registrant information
Name
Najmeh Ahramianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 370 3643
Email address
n.ahramianpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-07-20, 1402/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Radiofrequency-Assisted Subcision Treatment Compared to Combined Platelet-Rich Plasma (PRP) and Radiofrequency-Assisted Subcision Treatment on Scars Left by Acne Vulgaris
Public title
Effectiveness of Radiofrequency-Assisted Subcision Treatment Compared to Combined PRP Treatment on Scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People Must be Over 18 Years Old and Have Mild to Moderate Atrophic Scars
Exclusion criteria:
People with Underlying Diseases such as Cardiac Pacemakers, Metal Implants Inside the Body
People with Active Acne Lesions or Infection on Scar Lesions
People Who Have Benefited from other Scar Improvement Treatments Such as Laser, Physical and Chemical Exfoliation in The Last 4 Months
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
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 Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.KMU.AH.REC.1401.207
Health conditions studied
1
Description of health condition studied
Mild to Moderate Atrophic Scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Mild to Moderate Atrophic Scar
Timepoint
3 Months
Method of measurement
Through the cannula of 18 devices(Radiofrequency)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 People Who Refer to the Skin Clinic are Over 18 Years Old and Have Mild to Moderate Atrophic Scars. First, the Lesions of Each Patient are Photographed and the Number of Scar Lesions is Determined along with its type, and the Lesions are Graded Qualitatively and Quantitatively. Then each Patient Will Undergo One Treatment Session. For all Patients, RF-Subcision will be Performed on both sides of the Face. Then one Side of the Face is Randomly treated with Platelet-Rich Plasma.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Najmeh Ahramiyanpour
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
najmeh.pour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramiyanpour
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 917 370 3643
Email
najmeh.pour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramiyanpour
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
0983431328000
Email
najmeh.pour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramiyanpour
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
najmeh.pour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramiyanpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
najmeh.pour@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
No - There is not 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