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IRCT20181006041252N2 IRCT 2018-11-29 Sabzevar University of Medical Sciences Comparison of the effect of Cysteamine 5% cream with Tranexamic acid Mesotherapy on the severity of epidermal Melasma. Comparison of the effect of Cysteamine 5% cream with Tranexamic acid Mesotherapy on the severity of epidermal Melasma. 2018-10-29 anticipated 54 Complete https://irct.ir/trial/35453 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization based on permutation. Accordingly, 27 blocks were allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, group A was treated with Cysteamine 5% cream and Group B treated with Tranexamic Acid Mesotherapy, Blinding description: Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The outcome evaluator is unaware of the groups. 3 Epidermal Melasma. Intervention 1: Intervention group: Patients in this group use cysteamine 5% cream at night for 2 months, and also during a day they use a sunscreen with SPF 25% with zinc oxide 7.5% daily. Intervention 2: Intervention group: In this group, 4 mg/cc of tranexamic acid will be injected intradermally every 4 weeks, and The skin of the patient was rinsed with normal saline and then anesthetized with local anesthetic ointment (ELMA) for 40 to 60 minutes, and then, the tranexamic acid is injected at intervals of 10 mm from the involved area to three areas for full coverage of the lesion using an insulin syringe (Nidel 28J) under sterile conditions. In addition, the injectable dose will not exceed 8 mg/cc during three injections per injection. During a day they will use a sunscreen with SPF 25% with zinc oxide 7.5% daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr. Maryam Karrabi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 Marikori90@gmail.com Sabzevar University of Medical Sciences scientific Dr. Maryam Karrabi
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1604 Marikori90@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 50 years Patients who have been at least 6 months old since their illness Patients who have not received any medication for at least 2 months 20 years 50 years Female History of Endocrine diseases, pregnancy and breast feeding Any Corticosteroids treatment 3 months before study Use of oral contraceptive pills before study Other skin diseases L85 Other epidermal thickening Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group use cysteamine 5% cream at night for 2 months, and also during a day they use a sunscreen with SPF 25% with zinc oxide 7.5% daily. Intervention group: In this group, 4 mg/cc of tranexamic acid will be injected intradermally every 4 weeks, and The skin of the patient was rinsed with normal saline and then anesthetized with local anesthetic ointment (ELMA) for 40 to 60 minutes, and then, the tranexamic acid is injected at intervals of 10 mm from the involved area to three areas for full coverage of the lesion using an insulin syringe (Nidel 28J) under sterile conditions. In addition, the injectable dose will not exceed 8 mg/cc during three injections per injection. During a day they will use a sunscreen with SPF 25% with zinc oxide 7.5% daily Determine the severity of the area involved in Melasma. Timepoint: Week 4 and 8 after starting the intervention for Tranexamic acid and months 2 and 4 after the intervention for the Cysteamine group. Method of measurement: Based on Derma catch® score and MASI index (Melasma Area Severity Index). Sabzevar University of Medical Sciences Approved 2018-10-29 Ethics committee of Sabzevar University of Medical Sciences Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city Sabzevar Razavi Khorasan Iran (Islamic Republic of)