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IRCT20210608051516N1 IRCT 2021-06-12 Ahvaz University of Medical Sciences Microneedling with tranexamic acid and also microneedling with vitamin C for the treatment of melasma Evaluation of the effectiveness of microneedling with Tranexamic acid in comparison with microneedling with vitamin C in the treatment of melasma 2021-06-20 anticipated 34 Complete https://irct.ir/trial/56761 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Melasma. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: 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: En Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Dermatologists Academic researchers Permitted analyzes: descriptive Where to obtain: En E.mail : raeispour.maryam@gmail.com tel : 00989161168820 How to obtain: The requested information will be provided to the applicant one month after receiving the email. Comments:
public Maryam Raeispour
No. 12, East Motahhri Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155686448 +98 61 3336 6086 raeispour.maryam@gmail.com Ahvaz University of Medical Sciences scientific Maryam Raeispour
No. 12, East 7th Street, Kianpars
Ahvaz Iran (Islamic Republic of) 6155686448 +98 61 3336 6086 raeispour.maryam@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women 18 to 50 years old with symmetrical and bilateral facial melasma 18 years 50 years Female 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 L81.1 Chloasma Treatment - Other Treatment - Other 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) 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) 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. 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. Patient satisfaction with melasma treatment. Timepoint: فارسیانگلیسی4 weeks after treatment. Method of measurement: questionnaire. Vice Chancellor for Research, Ahvaz University of Medical Sciences Approved 2021-06-01 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences 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 Ahvaz Khouzestan Iran (Islamic Republic of)