Platelet Rich Plasma Versus Tranexamic Acid mesoneedling in Melasma Treatment: A Split Face Comparative Study
Design
This phase 1 study is performed on 45 patients with melasma. At each session, the patient's right side receives the PRP along with the microneedling and the patient's left side receives the OAs along with the microneedling. This method will be done once a month for 4 sessions. All patients are photographed before digital therapy and 1 month after the fourth session by digital camera and Visophys. To determine the extent of improvement and compare the two groups, at the end of the study, photos of patients are examined by two neutral dermatologists. Patients' satisfaction and tolerance are also recorded and the results are compared.
Settings and conduct
This project is performed in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences and in each session, the patient's right side receives PRP with microneedling and the patient's left side receives ﻧﮕﺰaa ﺳﯿﺪ with microneedling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with melasma on the cheeks and other areas of the face. Exclusion criteria: Any complication that is related to the treatment process or is not tolerated by the patient, The patient does not want to continue treatment for any reason, Cancers, pregnancy, lactation, DVT, pulmonary embolism, stroke, Incidence of drug allergies, Occurrence of hypertrophic or colloidal scars at the treatment site
Intervention groups
In each session, one side receives PRP along with microneedling (intervention) and the other group receives PR with microneedling (control).
Main outcome variables
Melasma area brightness; side effects; Patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N12
Registration date:2022-05-01, 1401/02/11
Registration timing:registered_while_recruiting
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
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
2022-04-19, 1401/01/30
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Platelet Rich Plasma Versus Tranexamic Acid mesoneedling in Melasma Treatment: A Split Face Comparative Study
Public title
PRP Versus Tranexamic Acid mesoneedling in Melasma Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with melasma on the cheeks and other areas of the face
Exclusion criteria:
Any complication that is related to the treatment process or is not tolerated by the patient
The patient does not want to continue treatment for any reason
Cancers, pregnancy, lactation, DVT, pulmonary embolism, stroke
Incidence of drug allergies
Occurrence of hypertrophic or colloidal scars at the treatment site
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In each session, one group receives PRP along with microneedling and the other group receives PR with microneedling. Only the he data analyzer will not have information from the intervention groups.
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
2021-04-07, 1400/01/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.032
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81
ICD-10 code description
Other disorders of pigmentation
Primary outcomes
1
Description
Melasma area recovery rate
Timepoint
Before treatment and 1 month after the last session
Method of measurement
Visioface
Secondary outcomes
1
Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit
2
Description
satisfaction
Timepoint
1 months after the last session
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: At each session, the right side of the patient's face receives PRP along with microneedling.
Category
Treatment - Other
2
Description
Control group: At each session, the left side of the patient's face receives ohs with microneedling.
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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
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, 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, Tehran
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
Masoumeh Roohaninasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Fax
Email
masoomehrohani@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, Tehran
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