Evaluation of safety and effectiveness of liposomal hyaluronic acid, PRP and vitamin C in rejuvenation and brightening under the eyes
Design
Phase 1-2, non-random assignment to intervention and control groups, 3 intervention groups and 6 control groups, single blind, parallel
Settings and conduct
This study is conducted at the Skin and Stem Cell Research Center in the field of treating dark circles under the eyes. Three products will be evaluated locally in three intervention groups with 6 local control groups along with the microneedling method. The evaluator will be blinded to the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: darkness and wrinkles in the lower eyelid area, which need to be treated according to the opinion of the hospital doctor and the patient's desire. exclusion criteria: patients who had undergone previous surgery in the eyelid area, have had previous minimally invasive treatments such as botulinum toxin or fillers in the eyelid area.
Intervention groups
Intervention group: patients use liposomal hyaluronic acid topically daily for three months. Control group: patients use liposomal platelet-rich plasma product topically for three months. Control group: patients receive platelet-rich plasma products three times with a one-month interval after performing microneedling locally. Intervention group: patients use liposomal vitamin C topically daily for three months. Control group: patients receive topical vitamin C product three times with an interval of one month after performing microneedling. Control group: patients use hyaluronic acid topically daily for three months. Control group: patients use platelet rich plasma topically daily for three months. Control group: patients use vitamin C topically daily for three months.
Main outcome variables
Darkness under the eyes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N28
Registration date:2023-05-06, 1402/02/16
Registration timing:prospective
Last update:2023-05-06, 1402/02/16
Update count:0
Registration date
2023-05-06, 1402/02/16
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
2023-05-10, 1402/02/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and effectiveness of liposomal hyaluronic acid, PRP and vitamin C in rejuvenation and brightening under the eyes
Public title
Evaluation of safety and effectiveness of liposomal hyaluronic acid, PRP and vitamin C in rejuvenation and brightening under the eyes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Darkness and wrinkles in the lower eyelid area, which need to be treated according to the opinion of the hospital doctor and the patient's desire.
Exclusion criteria:
Patients who had undergone previous surgery in the eyelid area
Have had previous minimally invasive treatments such as botulinum toxin or fillers in the eyelid area.
Patients with active skin disorders or inflammation, acute or chronic infection, tumors or cancer
Patients under anticoagulant treatment
smokers
Age
From 21 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data evaluator is given a general explanation of the study, but one method is not presented as superior to another, and no preference is given to one of the interventions. As a result, this person is blind to the effect of the intervention. The patient and the doctor will not be blinded and will know about the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.538
Health conditions studied
1
Description of health condition studied
Darkening under the eye
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of darkness under the eyes
Timepoint
prior to treatment, three and six months after the last treatment session
Method of measurement
VisioFace device
2
Description
The amount of wrinkles under the eyes
Timepoint
prior to treatment, three and six months after the last treatment session
Method of measurement
Visioface
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
prior to treatment, three months and six months after the last treatment session
Method of measurement
Standard questionnaires visual analogue scale (VAS)
Intervention groups
1
Description
Intervention group: Patients use 1 cc liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) products topically in the area under the eyes once a day for three months.
Category
Treatment - Other
2
Description
Control group: Patients receive 1 cc hyaluronic acid products (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after performing microneedling.
Category
Treatment - Other
3
Description
Intervention group: Patients use 1 cc liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company)products topically in the under-eye area once a day for three months.
Category
Treatment - Other
4
Description
Control group: Patients receive 1 cc platelet-rich plasma product (Zist Sakht Bonyan Pars Company) locally in the clinic three times with an interval of one month after microneedling.
Category
Treatment - Other
5
Description
Intervention group: Patients use 1 cc liposomal vitamin C (Zist Sakht Bonyan Pars Company) topically in the area under the eyes once a day for three months.
Category
Treatment - Other
6
Description
Control group: Patients receive 1 cc vitamin C product (Zist Sakht Bonyan Pars Company) topically in the area under the eyes three times with an interval of one month after performing microneedling.
Category
Treatment - Other
7
Description
Control group: Patients use the 1 cc non- liposomal hyaluronic acid (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months.
Category
Treatment - Other
8
Description
Control group: Patients use 1 cc non- liposomal platelet-rich plasma (Zist Sakht Bonyan Pars Company) product topically in the under-eye area once a day for three months.
Category
Treatment - Other
9
Description
Control group: Patients use 1 cc non- liposomal vitamin C (Zist Sakht Bonyan Pars Company) product topically in the area under the eyes once a day for three months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of 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
Akbar Fatuhi
Street address
Keshavarz Blvd., corner of Qods St., Central University Organization, floor 6th vice president of research and technology
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 81631
Email
ir.ac.tums@vcr
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, 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, 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 Kamraniye St.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center, 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