Fractional Erb-YAG laser versus combined fractional Erb-YAG laser and local platelet-rich plasma in facial rejuvenation, in patients reffered to Shohadaye Tajrish hospital, 2019-2020
Determination and comparison of the efficacy of topical erbium fractional laser and topical PRP simultaneously in the treatment of facial wrinkles based on skin elasticity measurement by Reviscometer
Design
The present study is a randomized double-blind face-split Trial clinical trial. The study design and type of patient allocation will be in parallel.
Settings and conduct
The present study is a randomized double-blind face-split Trial clinical trial that will be performed in one year at Shohadaye Tajrish Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- Women 60-60 years
2- Mild to moderate wrinkles at rest
Exclusion criteria:
1. Male gender
2. Under 35 and over 60 years of age
3. Breastfeeding and pregnancy
4- Perform other facial cosmetic procedures like Botox, Dermabrasion, Chemical Peeling and Face Lift in the past 6 months
5- Oral isotretinoin in the past 6 months
6- History of colloid formation
7. Not willing to participate in the study
Intervention groups
One half was randomly assigned (using a random number table) to be treated with an Er: YAG laser with normal saline without any therapeutic effect, and the other half was treated with an Er: YAG laser with PRP.
Main outcome variables
The rate of skin rejuvenation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200107046041N1
Registration date:2020-03-30, 1399/01/11
Registration timing:registered_while_recruiting
Last update:2020-03-30, 1399/01/11
Update count:0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Hamideh Moravej farshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
hamidehmoravej@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fractional Erb-YAG laser versus combined fractional Erb-YAG laser and local platelet-rich plasma in facial rejuvenation, in patients reffered to Shohadaye Tajrish hospital, 2019-2020
Public title
Fractional Erb-YAG laser versus combined fractional Erb-YAG laser and local platelet-rich plasma in facial rejuvenation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women 60-35 years
Mild to moderate wrinkles at rest
Exclusion criteria:
Male gender
Under 35 and over 60 years of age
Breastfeeding and pregnancy
Perform other facial cosmetic procedures like Botox, Derm abrasion, Chemical Peeling and Face Lift in the past 6 months
Oral isotretinoin in the past 6 months6- History of colloid formation
Not willing to participate in the study
Age
From 35 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using Random Number Table
Blinding (investigator's opinion)
Double blinded
Blinding description
The ambiguity in this study would be that both the researcher (and the laser operator) and the patients were unaware of the treatment or treatment group received. The method of double blinding would be to ask a third party other than the researcher and operator to cover the saline and PRP tubes with colored labels (each a special color) so that neither the researcher nor The operator of the device used the material and diagnose it based on color.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
ir.sbmu.src.rec.1398.022
Health conditions studied
1
Description of health condition studied
Skin Rejuvenation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wrinkle removal
Timepoint
Patients are monitored for reviscometer and digital imaging in the first session (baseline), second and third treatment, and 3 months after the last laser session.
Method of measurement
The results are evaluated qualitatively and quantitatively: In the qualitative method, the patients are photographed with the same digital camera before the start of the project and then at each visit. The improvement is in the percentage of zero to one hundred. Finally, the rate of recovery is defined as No response (less than 10%), mild response (10-25%), moderate response (25-50%) and good response (50-75%) Excellent response (over 75%) Is. Quantitative testing is done by the multi probe adapter system MPA5. MPA5 is a device for checking the suitability of various biophysical parameters of the skin. Using Reviscometer based on Resonance running time acoustic waves and mechanical properties of skin are measured skin resonance time and thus determine the biological age of the skin at different angles.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One half of face PRP 10cc 3session 1month interval with fractional erb yag laser total fluence 60 j on cm2 pulse duration400 microsecond 3session 1month interval
Category
Treatment - Devices
2
Description
intervention group 2:Another half of face fractional erb yag laser total fluence 60 j on cm2 pulse duration400 microsecond 3session 1month interval
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr Arash Rahbar
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Web page address
http://shmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Robati
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Dean.medicalschool@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Arash Rahbar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Arashrahbar10@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Arash Rahbar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Arashrahbar10@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Rahbar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Shahrdari
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Arashrahbar10@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