Assessing the effectiveness, safety and patient satisfaction of intradermal tranxamic acid injection in comparision with fractional Q-Switch Nd-yag laser for melasma treatment
Evaluation of the efficacy of intra-dermal tranxamic acid injection in comparison with Q switch Nd-YAG fractional laser in patients referred to the Clinic of skin and Stem Cell Research Center
Design
Two arm parallel group randomised trial with two intervention groups and sample size includes 28 patients randomization is simple with use of randomization numbers table.
Settings and conduct
This study was conducted as a randomized trial. A total of 28 patients who will visit for melasma in the skin and Stem Cell Research Center The aim of this study was to investigate the effect of two treatment groups consist of laser fractional Q-switched on a monthly basis for up to four sessions and intra-lesional injections of tranxamic acid for 12 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria: women over the age of 18; moderate to severe melasma
exclusion criteria: pregnancy; lactation; patients who have received contraceptive drugs in the last 12 months; Patients with hemorrhagic or anticoagulant abnormalities; receiving another treatment for melasma at the same time and none of the patients should receive topical treatment for melasma for example hydroquinone one month before treatment.
Intervention groups
patients in group of intradermal tranxamic acid injection
paients in Q switch ND-YAG Fractional laser
Assessing the effectiveness, safety and patient satisfaction of intradermal tranxamic acid injection in comparision with fractional Q-Switch Nd-yag laser for melasma treatment
Public title
comparision of efficacy of intradermal tranxamic acid injection with fractional Q-Switch Nd-yag laser for melasma treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women over the age of 18
moderate to severe melasma
Exclusion criteria:
pregnancy
lactation
patients who have received contraceptive drugs in the last 12 months
Patients with hemorrhagic or anticoagulant abnormalities
anticoagulant dug using
receiving another treatment for melasma at the same time
receive topical treatment for melasma for example hydroquinone one month before treatment.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization
Randomization Tool: Random Numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Two blind dermatologists will give a score to patients graphies
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, Enghelab Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2018-02-27, 1396/12/08
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4672
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melanin index
Timepoint
before treatment session 8,12. three moth after treatment
Method of measurement
multi probe adaptor
2
Description
skin lightening
Timepoint
before treatment session 8,12. three moth after treatment
Method of measurement
colorimeter
3
Description
Modified MASI score
Timepoint
before treatment session 4,8,12. three moth after treatment
Method of measurement
clinicaly by the physician. face is divided into four parts: forehead, right malar, left malar and chin , and the degree of severity of melasma is measured based on three criteria. The percentage of area ( from zero to six points) and the degree of darkness are also categorized from zero to four points.
4
Description
patient satisffaction
Timepoint
in the end of study
Method of measurement
The patient's own assessment of the improvement of melasma is based on four points. Exercise: Improvement of more than 75% / fine: 75-51% Fairly good: 50-26% / Slight: 25-0%
5
Description
graphy
Timepoint
before treatment session 4,8,12. three moth after treatment
Method of measurement
visiofase
Secondary outcomes
empty
Intervention groups
1
Description
In the group treated with tranxamic acid: Prior to treatment, local anesthetic treatment, a 2.5% lidocaine hydrochloride plus 2.5% prilocaine for 20 to 20 minutes will be applied on site. for injection an insulin syringe 30 Gage will be used Injections will be done at intervals of 1 cm at a volume of 0.05 cc at each point , at concentrations of 4 mg per cc , weekly for 12 weeks in each area.
Category
Treatment - Drugs
2
Description
Intervention group: In the laser treatment group, forty-five to sixty minutes prior to treatment local anesthetia (a combination of 2.5% lidocaine and 2.5% prilocaine) will be applied on face to protect the eyes from the laser , eye shield is applied to the eye, and single-pulse laser with these specifications is done for the patients.Lasers are performed at intervals of four sessions for patients.Low fluence fractional Q-switch Nd yag laser: fluence:1.3j/cm2 – energy:500- spot size:7mm-frequncy:5Htz
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem Cell Research Center
Full name of responsible person
Nahid Nikkhah
Street address
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nahid_nickhah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Dr Mohammad Ali Nilforooshzadeh
Street address
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nahid_nickhah@yahoo.com
Grant name
Grant code / Reference number
123700016
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem Cell Research Center
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
Tehran University of Medical Sciences
Full name of responsible person
Nahid Nikkhah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nahid_nickhah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor of Tehran Univesity
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nahid Nikkhah
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No4,Mayam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
nahid_nickhah@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
Yes - There is a plan to make this available
Title and more details about the data/document
All of the above is publicly available, Except for cases where patients are identified
When the data will become available and for how long
Start the access period 4 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
This data will be provided to researchers only for the purpose of allowing future studies and planning of future studies,In the case of direct use of data in future studies, the Center's intellectual property rights should be maintained
From where data/document is obtainable
Secretariat of the skin and Stem Cell Research Center 02122215558
What processes are involved for a request to access data/document
In order to access the patients' data, coordination with Mrs. Mahmoodbeig should be carried out and a letter asking for access to the data be delivered to them, so that, after coordinating with the head of the research center, this work is feasible