Determining the effectiveness and side effects of using PRP with Erbium laser in the treatment of dark circles
Design
The aim of this study was to evaluate the efficacy and side effects of using Erbium laser and PRP (Intervention group) in comparison Erbium laser and physiological serum (control group) in the treatment of dark circles in 32 patients which have been entered into the study by block randomization method. In each session immediately after the laser therapy, one side of the patient's face, PRP, and the other side of the face, the physiologic serum was applied locally to the dark circles for one hour. This procedure is repeated 3 times at intervals of 4 weeks.
Settings and conduct
This design is done at the skin and stem cell research center of Tehran university of medical sciences and without the patient's knowledge about the intervention groups, in the dark area around the eyes, after the Erbium laser, one side of the face of PRP and other side for blinding is used of the physiology serum the dark circles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-50 years old; the cause of darkness, structural and reducing fat in this area is not. Exclusion criteria: pregnancy or breastfeeding; active infection in face; history of cancer.
Intervention groups
First intervention group: the circular darkness on one side of the face is treated with Erbium laser and PRP. Second intervention group: the dark circles of the eye on other side of the face is treated with Erbium laser and physiological serum.
Main outcome variables
Melanin Index; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N28
Registration date:2020-07-20, 1399/04/30
Registration timing:registered_while_recruiting
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of the combination therapy with Erbium laser and PRP ( Platelet Rich Plasma) in the treatment of periorbital dark circles
Public title
The effectiveness of PRP and Erbium laser in the treatment of dark circles around the eyes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The cause of darkness, structural and reducing fat in this area is not
Age between 18 and 50 years old
Exclusion criteria:
Active infection in the face
Pregnancy and breastfeeding
History of cancer
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
A half face will be considered as the control group and one half as an intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, block randomization is used. 32 patients will be included in the study by available sampling method based on inclusion and exclusion criteria. Each patient was considered as a block and their left and right eyes were randomly assigned to two groups using cards with study groups written on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
On both sides of the face in the dark area around the patient's eye, an airbag laser will be performed, and without the patient knowing the location of each intervention group, after laser therapy, PRP will be used on one side of the face and physiological serum on the opposite side.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.TUMS.VCR.REC.1397.870
Health conditions studied
1
Description of health condition studied
Eye dark circles
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Preorbital hyperpigmentation
Timepoint
Session 0, 4 and 6 during treatment and 3 months after treatment
Method of measurement
Intensity of the darkening of the skin around the eyes compared to other areas of the face with Mexameter device.
2
Description
Satisfaction amount
Timepoint
After completion of treatment
Method of measurement
Comparison of reduction preorbital hyper pigmentation by patient , before and after treatment According to schedule ( score 0 to 10 )
Secondary outcomes
empty
Intervention groups
1
Description
Control group: (one side of the face) The dark area around the eye is first treated with Erbium laser, and then physiological serum is applied topically on the site for one hour. This method is repeated 3 times at intervals of 4 weeks.
Category
Treatment - Other
2
Description
Intervention group: (other side of the face) The dark area around the eye is first treated with Erbium laser, and then PRP is applied topically on the site for one hour. This method is repeated 3 times at intervals of 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Shiva Alavi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
shiva.alavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ali Karimi
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@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
Shiva Alavi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Shiva.alavi@yahoo.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
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
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
Mona Mahmoudbeyk
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
mmahoodbeyk@yahoo.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