Evaluation of the effectiveness of microneedling with tranexamic acid in comparison with microneedling with vitamin C in the treatment of melasma
Design
A clinical trial with a control group, with parallel groups, one-way blind, randomized, phase 3 on 34 patients, a random number table is used for randomization.
Settings and conduct
Your study is currently a clinical trial that has not received a blind and future. It has been affiliated with the Medical School of Ahvaz University of Medical Sciences in Ahvaz Imam Khomeini Hospital since June 1400.At the first visit, after taking a history, each patient is examined with a wood lamp and the type of melasma (epidermal, dermal, mixed) is determined. This study is a randomized clinical trial comparing the two sides of the face, right and left, and our two groups compared both sides of the face. There are also 2 treatment groups A and B.Microneedling with a sterile disposable cartridge of 36 needles with a depth of 2 to 3 mm with the aim of achieving spot bleeding in the skin of the affected area in the horizontal, vertical and diagonal directions is done. Acid and 5 cc ampoules of vitamin C are poured directly on the skin for one side of the face and immediately after microneedling, 5 cc of each of the ampoules mentioned on sterile gas (SOAK) is placed on the skin for 15 minutes. This method is performed 3 times in 2 weeks (weeks 0, 2 and 4) and the result is compared in weeks 2, 4, 8 and 12.
Participants/Inclusion and exclusion criteria
Admission requirements: Women 18 to 50 years old with symmetrical and bilateral facial melasma who have read and signed the consent form.
Intervention groups
Performing microneedling with tranexamic acid on one side of the patient's face and also microneedling with vitamin C on the other side of the face for people seeking melasma treatment
Main outcome variables
Treatment of melasma , Reduce pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210608051516N1
Registration date:2021-06-12, 1400/03/22
Registration timing:prospective
Last update:2021-06-12, 1400/03/22
Update count:0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Maryam Raeispour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 6086
Email address
raeispour.maryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
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
Evaluation of the effectiveness of microneedling with Tranexamic acid in comparison with microneedling with vitamin C in the treatment of melasma
Public title
Microneedling with tranexamic acid and also microneedling with vitamin C for the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 50 years old with symmetrical and bilateral facial melasma
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
Taking Medicines anticoagulants and anticonvulsants
Existence of allergy to studied drugs and topical lidocaine
History of melasma treatment in the past month
Active facial herpes simplex lesions
Facial warts
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization in treatment method A for the right side of the patient's face, microneedling treatment with tranexamic acid and for the left side, microneedling and vitamin C treatment are considered, and in treatment method B, the opposite is true for the left side of the patient's microneedling treatment with tranexamic acid and side The right treatment is considered microneedling and vitamin C.Using the coin toss method, if the Heads is observed, treatment method A will be assigned and if the treatment method Tails B is assigned to the patient.
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 side of the face.
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
2021-06-01, 1400/03/11
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.044
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melasma area and severeity index score (MASI SCORE)
Timepoint
It is done at the beginning of the study and weeks 2, 4, 8 and 12
Method of measurement
Face photography with camera
2
Description
Recovery rate of melasma lesions
Timepoint
It is done at the beginning of the study and weeks 2, 4, 8 and 12
Method of measurement
Face photography with camera
Secondary outcomes
1
Description
Patient satisfaction with melasma treatment
Timepoint
فارسیانگلیسی4 weeks after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group 1: Microneedling to a depth of 2 to 3 mm of the skin with tranexamic acid in 3 times with an interval of 2 weeks in one of the studied species (random selection)
Category
Treatment - Other
2
Description
Intervention group 2: Microneedling to a depth of 2 to 3 mm of skin with vitamin C in 3 times 2 weeks apart in the other species studied (randomly selected)
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
Maryam Raeispour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 12, East Motahhri Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155686448
Phone
+98 61 3336 6086
Email
raeispour.maryam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Raeispour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 12, East 7th Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155686448
Phone
+98 61 3336 6086
Email
raeispour.maryam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Raeispour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 12, East Motahhri Street, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155686448
Phone
+98 61 3336 6086
Email
raeispour.maryam@gmail.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
Participants' personal information including age, sex, complications and improvement of facial melasma before and after microneedling along with tranexamic acid and microneedling with vitamin C
When the data will become available and for how long
En Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions