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Comparing the effect of RF fractional laser and Microneedling on Skin rejuvenation, Skin's open pores and Skin lightening

Protocol summary

Study aim
Comparing the effect of RF fractional laser and microneedling on skin rejuvenation, skin's open pores and skin lightening
Design
This clinical trial has two intervention groups, with parallel groups, non-random sample selection and the choice of treatment for ethical considerations is the choice of patients themselves.
Settings and conduct
25 people in each group enter each of the intervention groups according to the inclusion criteria (Location: Dr. Mamizadeh Dermatology Clinic). Finally, after the treatment, the two groups are compared in terms of Skin open Pores, skin lightening and rejuvenation. Microneedling will be performed by Amiea device in 3 treatment sessions with three-week intervals. Fractional RF laser will be performed by Secret device in 3 sessions at 4-week intervals. Depending on the patient's condition such as age and location of the lesion, The device cartridge and the target depth will be adjusted
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in reasearch, Age range 20 to 50 years, Absence of inflammatory Skin disease, No history of psychiatric disordes, No history of recurrent herpes, No history of Colloidization, Absence of underlying diseases, Do not have a history of treatment with Microneedling and RF fractional Laser Exclusion criteria: Patients who do not want to continue treatment, Simultaneous use of drugs affecting the skin and other methods of rejuvenation, Having active acne
Intervention groups
In the first group, there are 25 people who want to rejuvenate the skin, close open pores and lighten the skin at the same time by microneedling method. In the first group, there are 25 people who want to rejuvenate the skin, close open pores and lighten the skin at the same time by fractional RF Laser method.
Main outcome variables
Skin rejuvenation, Skin's open Pores, Skin lightening

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211212053366N1
Registration date: 2022-01-05, 1400/10/15
Registration timing: registered_while_recruiting

Last update: 2022-01-05, 1400/10/15
Update count: 0
Registration date
2022-01-05, 1400/10/15
Registrant information
Name
Mohammad Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3224 8022
Email address
mohammadj2233@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-28, 1400/10/07
Expected recruitment end date
2022-01-27, 1400/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of RF fractional laser and Microneedling on Skin rejuvenation, Skin's open pores and Skin lightening
Public title
Comparing the effect of RF fractional laser and Microneedling on Skin rejuvenation, Skin's open pores and Skin lightening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in reasearch Absence of inflammatory Skin disease No history of psychiatric disordes No history of Colloidization Absence of underlying diseases such as Diabetes and Rheumatic diseases Do not have a history of treatment with Microneedling and RF fractional Laser Age range 20 to 50 years No history of recurrent herpes
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Ethics committee, Ilam University of Medical Sciences, pazhuhesh Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.MEDILAM.REC.1400.154

Health conditions studied

1

Description of health condition studied
Skin rejuvention, Skin's open Pores and Skin lightening
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue

Primary outcomes

1

Description
Skin rejuvenation
Timepoint
In 3 Visits with 3 week intervals
Method of measurement
Researcher made Questionnaire

2

Description
Skin's open Pores
Timepoint
In 3 Visits with 3 week intervals
Method of measurement
Researcher made Questionnaire

3

Description
Skin lightening
Timepoint
In 3 Visits with 3 week intervals
Method of measurement
Researcher made Questionnaire

Secondary outcomes

1

Description
Skin Spots after treatment
Timepoint
One week after the last treatment session
Method of measurement
Researcher made Questionnaire

2

Description
Bruising after treatment
Timepoint
One week after the last treatment session
Method of measurement
Researcher made Questionnaire

3

Description
Erythema after treatment
Timepoint
One week after the last treatment session
Method of measurement
Researcher made Questionnaire

4

Description
Swelling after treatment
Timepoint
One week after the last treatment session
Method of measurement
Researcher made Questionnaire

Intervention groups

1

Description
Intervention group 1: In the first group, there are 25 people who want to rejuvenate the skin, close open pores and lighten the skin simultaneously by microneedling. Microneedling will be performed by Amiea device in 3 treatment sessions with three-week intervals. Depending on the patient's condition, such as age and location of the cartridge, the device and the target depth will be adjusted.
Category
Treatment - Devices

2

Description
Intervention group 2: In the second group, there are 25 people who want to rejuvenate the skin, close open pores and lighten the skin simultaneously with fractional RF laser method. Fractional RF laser will be performed by Secret device in 3 sessions with 4-week intervals. Depending on the patient's condition, such as age and location of the cartridge, the device and the target depth will be adjusted.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Mamizadeh Dermatology and Beauty Clinic
Full name of responsible person
Mina Mamizadeh
Street address
Clinic Dr Mamizadeh, Rashidi Alley, Saadi Ave Ayatollah Heydari Ave
City
Ilam
Province
Ilam
Postal code
6931435802
Phone
+98 84 3335 1928
Email
mamizadeh-m@medilam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Kafashian
Street address
Ilam University of Medical Sciences, Pazhuhesh Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
research@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Jamali
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 6, Aria Building, Nasim 1 Alley, Shahrvand Ave, Shahid Beheshti Blvd
City
Ilam
Province
Ilam
Postal code
6931435802
Phone
+98 84 3224 8022
Fax
Email
mohammadj2233@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mina Mamizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Khomeini Hospital, Ayatollah Heydari Ave
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3335 1928
Email
mamizadeh-m@medilam.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Jamali
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 6, Aria Building, Nasim 1 Alley, Shahrvand Ave, Shahid Beheshti Blvd
City
Ilam
Province
Ilam
Postal code
6931435802
Phone
+98 84 3224 8022
Fax
Email
mohammadj2233@gmail.com

Sharing plan

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
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
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If specify the type of study and how to use the data in accordance with the rules of Ilam University of Medical Sciences
From where data/document is obtainable
Dr Mohammad Jamali mohammadj2233@gmail.com
What processes are involved for a request to access data/document
After the request and notification of the research deputy, action will be taken as soon as possible
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