Determination of the effectiveness of microneedling with tranexamic acid in comparison with microneedling with vitamin C in the treatment of dark circles around the eyes
Design
A clinical trial with a control group, with parallel, single-blind, randomized, phase 3 groups on 37 patients. The coin toss method will be used for randomization.
Settings and conduct
This study is a randomized comparative clinical trial comparing the two sides under the eye. Microneedling will be performed with the aim of achieving spot bleeding in the skin of under eyes.After finishing tranexamic acid on one side, vitamin C is used on the other side. This procedure is performed three times in two weeks (weeks 0, 2 and 4). At each session and before the start of treatment, a photo of the patient is taken.And the pigmentation of the under the eyes is compared at the beginning of treatment, 2,4,6,12 weeks. The results of this study are evaluated by comparing the photographs.
Participants/Inclusion and exclusion criteria
People 18 to 50 years old with dark circles around the eyes
Exclusion criteria:
Pregnant women and breastfeeding mothers
Taking oral contraceptive pills during the last 12 months and during the study
Existence of any history of coagulation disorders and thrombotic problems
Consumption of anticoagulants
Existence of allergy to the studied drugs and topical lidocaine
History of treatment of dark circles around the eyes during the last six months
Inherited or acquired diseases of connective tissue
History of colloidal scarring
History of using isotretinoin during one year before treatment
Intervention groups
Microneedling with tranexamic acid for one side around the eye As well as microneedling with vitamin C for the other side of the eye for people with dark circles
Main outcome variables
dark circles under the eyes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200302046669N1
Registration date:2021-06-12, 1400/03/22
Registration timing:registered_while_recruiting
Last update:2021-06-12, 1400/03/22
Update count:0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Fatemeh Badakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 4866
Email address
badakhsh_f@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
بررسی اثر بخشی میکرونیدلینگ با ترانگزامیک اسید در مقایسه با میکرونیدلینگ و ویتامین سی در درمان تیرگی دور چشم
Public title
بررسی اثر بخشی میکرونیدلینگ با ترانگزامیک اسید در مقایسه با میکرونیدلینگ و ویتامین سی در درمان تیرگی دور چشم
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 18 to 50 years old with dark circles around the eyes
Exclusion criteria:
Pregnant women and breastfeeding mothers
Taking oral contraceptive pills during the last 12 months and during the study
Existence of any history of coagulation disorders and thrombotic problemsCommunity Verified icon
Taking anticoagulants
Existence of allergy to the studied drugs and topical lidocaine
History of dark circles treatment around the eyes during the last six months
Hereditary or acquired connective tissue diseases
History of colloidal scarring
History of isotretinoin use within one year before treatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Our two comparison groups are both under the eyes, and we have two treatment groups, A and B.For randomization, in treatment method A, microneedling and tranexamic treatment is considered for the right side of the patient's face and microneedling and vascorbic acid treatment is considered for the left side. In treatment method B, it will be the opposite.This means that we will dedicate the right side of the patient's face to the treatment of vascorbic acid microneedling and the left side to the microneedling and tranexamic treatment. Using the coin toss method, method A will be assigned to the patient if observed, and treatment method B will be assigned to the patient if the line is observed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one-sided blind in which only the participant is kept blind. The participant is aware of the type of drugs used but is not aware of how they are allocated to the left or right Under the eyes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
13th floor, Block A ,Treatment and Medical Education ,Headquarters of the Ministry of Health, Iran TV St ,between South Flamek and Zarafshan ,Ghods Town (West), Tehran
City
ahvaz
Province
Khouzestan
Postal code
1111111111
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.045
Health conditions studied
1
Description of health condition studied
infraorbital dark circle
ICD-10 code
H02.71
ICD-10 code description
Chloasma of eyelid and periocular area
Primary outcomes
1
Description
Percentage of improvement of opacity after 3 sessions of treatment
Timepoint
It is done at the beginning of the study and weeks 2, 4, 8 and 12
Method of measurement
عکس برداری با دوربین
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Microneedling to a depth of 2 to 3 mm of the skin with tranexamic acid 3 times at intervals of 2 weeks on one side under the eye. Random selection
Category
Treatment - Other
2
Description
Intervention group: Microneedling to a depth of 2 to 3 mm with vitamin C skin 3 times 2 weeks apart on one side under the eye. Random selection
Golestan , Ahvaz Jondishapur University of Medical Scinces
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Badakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 5, 19th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155887137
Phone
+98 61 3337 4866
Email
badakhsh_f@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Badakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 5, 19th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155887137
Phone
+98 61 3337 4866
Email
badakhsh_f@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Badakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 5, 19th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155887137
Phone
+98 61 3337 4866
Email
badakhsh_f@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Personal information of participants including age, sex, complications and degree of hyperpigmentation under the eyes before and after microneedling along with tranexamic acid and microneedling with vitamin C
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions