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IRCT20180418039349N1 IRCT 2018-06-27 Skin and Stem Cell Research Center comparision of efficacy of intradermal tranxamic acid injection with fractional Q-Switch Nd-yag laser for melasma treatment Assessing the effectiveness, safety and patient satisfaction of intradermal tranxamic acid injection in comparision with fractional Q-Switch Nd-yag laser for melasma treatment 2018-05-22 anticipated 28 Complete https://irct.ir/trial/30927 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using simple randomization Randomization Tool: Random Numbers table, Blinding description: Two blind dermatologists will give a score to patients graphies. 3 melasma. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All of the above is publicly available, Except for cases where patients are identified When: Start the access period 4 months after printing the results To whom: Researchers working in academic institutions Conditions: 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 Where to obtain: Secretariat of the skin and Stem Cell Research Center 02122215558 How to obtain: 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 Comments:
public Nahid Nikkhah
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
tehran Iran (Islamic Republic of) 1937957511 +98 21 2221 5558 nahid_nickhah@yahoo.com Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No4, Mayam Alley, South Kamraniyeh Street, Tehran, Iran
tehran Iran (Islamic Republic of) 1937957511 +98 21 2221 5558 nilforoosh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) women over the age of 18 moderate to severe melasma 18 years no limit Female 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. L81.1 Chloasma Treatment - Drugs Treatment - Devices 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. 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 Melanin index. Timepoint: before treatment session 8,12. three moth after treatment. Method of measurement: multi probe adaptor. Skin lightening. Timepoint: before treatment session 8,12. three moth after treatment. Method of measurement: colorimeter. 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. 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%. Graphy. Timepoint: before treatment session 4,8,12. three moth after treatment. Method of measurement: visiofase. Skin and Stem Cell Research Center Approved 2018-02-27 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Enghelab Street,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)