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IRCT20221025056287N1 IRCT 2022-12-09 Ahvaz University of Medical Sciences Comparison of microneedling with Tranexamic acid and PRP in treatment of Melasma Evaluation of the effectiveness of microneedling with Tranexamic acid in comparison with microneedling with PRP in the treatment of melasma 2022-10-31 anticipated 23 Complete https://irct.ir/trial/66576 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We have two treatment groups of A and B in this study. For randomization, microneedling with Tranexamic acid is considered for the right side of patient's face and microneedling with PRP for the left side in group A. The treatment method in group B will be the opposite. This means that the right side of patient's face will be treated by microneedling with PRP and the left side by microneedling with Tranexamic acid. The treatment method of A and B will be determined using coin toss method, Blinding description: The patient is not aware of how the treatment is assigned to the right and left side of her face, but the therapist knows that. This method is that PRP and tranexamic acid are drawn in insulin syringes with the same appearance covered with adhesive medical tape, so that the therapist is aware of their contents, but the patient is not aware of the type of drug used on the right and left side of the face. 2 Melasma. Intervention 1: Intervention group 1: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 200 mg Tranexamic acid in 3 times with an interval of 3 weeks on one side of the subject's face (random selection). Intervention 2: Intervention group 2: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 2 cc PRP prepared by a standard PRP kit in 3 times with an interval of 3 weeks on one side of the subject's face (random selection). 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 Its release schedule is not yet known
public Havva Hajati
Dermatology clinic, Imam Khomeini Hospital, Azadegan (24 metri) Ave.
Ahvaz Iran (Islamic Republic of) 6193673111 009832921873 hajati.h@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nader Pazyar
Imam khomeini educational hospital, Azadegan Ave.
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2922 Dr.Pazyar@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 18-50 years old women with Melasma Symmetrical and bilateral facial Melasma 18 years 50 years Female Pregnant women Breastfeeding mothers Use of anticoagulants and anticonvulsants Being allergic to the study drugs and topical lidocaine History of Melasma treatment during the past month Active Herpes simplex lesions on the face Facial warts Any history of coagulation disorders and thrombotic problems L81 Other disorders of pigmentation Treatment - Other Treatment - Other Intervention group 1: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 200 mg Tranexamic acid in 3 times with an interval of 3 weeks on one side of the subject's face (random selection) Intervention group 2: performing Microneedling to a depth of 1.5 to 2 mm of the skin using a 36-needle disposable cartridge with 2 cc PRP prepared by a standard PRP kit in 3 times with an interval of 3 weeks on one side of the subject's face (random selection) Melasma measuring index (MASI SCORE). Timepoint: At the beginning of the study, the second and third sessions and 3 weeks after the completion of treatment sessions. Method of measurement: Taking photo of the face with camera. Ahvaz University of Medical Sciences Approved 2022-10-18 Ethics Committee of Golestan Educational, Research and Treatment Center Golestan Educational and Medical Center, Farvardin Ave, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)