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IRCT20181208041882N9 IRCT 2023-10-09 Yazd University of Medical Sciences Evaluation of topical tranexamic acid effectiveness in the treatment of melasma Evaluation of topical tranexamic acid versus oral tranexamic acid in the treatment of melisma: a randomized, double-blind clinical trial. 2022-05-20 anticipated 50 Complete https://irct.ir/trial/63420 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 50 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 10 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 50 is in 10 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 50, Blinding description: The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and delivers the appropriate medications to the patients. 3 Melasma. Intervention 1: Intervention group: Patients with melasma use Tranexamic acid capsules 250 mg orally twice a day for 8 weeks. Intervention 2: Intervention group: Patients with melasma use 5% tranexamic acid cream (manufactured in Yazd Faculty of Pharmacy) topically twice a day for 8 weeks. Yes - There is a plan to make this available What will be shared: After nonrecognition, all data can be share When: 6 months after publication To whom: All of researchers Conditions: nothing Where to obtain: Behrooz Heydari email: b.heydari@ssu.ac.ir How to obtain: Request your information by email. The data will be sent after a week. Comments:
public Behrooz Heydari
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences scientific Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Women with melasma from 18 to 60 years MMASI score greater than 8.5 Do not use oral contraceptives The patient has not received medication to treat melasma in the last three months 18 years 60 years Female Drug allergy Breastfeeding L81.1 Chloasma Treatment - Drugs Treatment - Drugs Intervention group: Patients with melasma use Tranexamic acid capsules 250 mg orally twice a day for 8 weeks. Intervention group: Patients with melasma use 5% tranexamic acid cream (manufactured in Yazd Faculty of Pharmacy) topically twice a day for 8 weeks. Evaluation of of melasma improvement. Timepoint: Weeks 0, 4, 8. Method of measurement: MASI ( Melasma Area Severity Index) Score. Yazd University of Medical Sciences Approved 2019-05-19 Ethics committee of Yazd University of Medical Sciences Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq Yazd Yazd Iran (Islamic Republic of)