A comparative study of the effectiveness and side effects of using a combination of platelet-rich plasma and adipose-derived stem cells with platelet-rich plasma treatment alone in dark circles around the eyes.
A comparative study of the effectiveness and side effects of using a combination of platelet-rich plasma and adipose-derived stem cells with platelet-rich plasma treatment alone in dark circles around the eyes.
Design
Clinical trial with one control group and one intervention group, with parallel groups, single-blind, Non-random assignment to intervention and control groups, phase 1-2 on 20 patients with periorbital dark circles
Settings and conduct
The intervention site is Skin and Stem Cell Research Center of Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-65 years; patients with periorbital dark circles. Exclusion criteria: Active infection on face, pregnancy, Breastfeeding, history of cancer, structural darkening or loss of fat around the eyes
Intervention groups
Intervention group: In each session, patients are treated by injecting half a cc of conditioned medium derived from adipose tissue cells and half a cc of PRP, twice with an interval of four weeks. Control group: In each session, patients are treated by injecting half a cc of normal saline and half a cc of PRP twice with an interval of four weeks.
Main outcome variables
Periorbital dark circles; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N49
Registration date:2024-07-10, 1403/04/20
Registration timing:registered_while_recruiting
Last update:2024-07-10, 1403/04/20
Update count:0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness and side effects of using a combination of platelet-rich plasma and adipose-derived stem cells with platelet-rich plasma treatment alone in dark circles around the eyes.
Public title
Investigating the combination of platelet-rich plasma and fat-derived stem cells in dark circles around the eyes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 18 to 65 years
Patient with periorbital dark circles
Exclusion criteria:
Active infection on face
Pregnancy
Breastfeeding
History of cancer
Structural dark circles or under eye loss of fat
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be done as single-blind and only the outcome evaluator will be unaware of the treatment method. The patient and the doctor will have enough information about the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Ethics Committee in Research Faculty of Medicine-Tehran University of Medical Sciences
Street address
Ethics Committee, Technology and Research office, Ghods st., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.471
Health conditions studied
1
Description of health condition studied
Periorbital dark circles
ICD-10 code
H02.71
ICD-10 code description
Chloasma of eyelid and periocular area
Primary outcomes
1
Description
Periorbital dark circles
Timepoint
Before and 1 months after treatment
Method of measurement
severity of under eye dark halos in comparison to the rest of the face, using mexameter device
Secondary outcomes
1
Description
Satisfaction rate
Timepoint
1 month after the last meeting
Method of measurement
Comparing the severity of periorbital dark circles, before and after treatment (score from 0 - 10)
Intervention groups
1
Description
Intervention group: In each session, patients are treated by injecting half a cc of conditioned medium derived from adipose tissue cells and half a cc of PRP, twice with an interval of four weeks.
Category
Treatment - Other
2
Description
Control group: In each session, patients are treated by injecting half a cc of normal saline and half a cc of PRP twice with an interval of four weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem cell Research Center Clinic, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8163 3698
Email
vcr@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
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.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
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
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
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
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