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IRCT20201205049603N1 IRCT 2021-02-08 Esfahan University of Medical Sciences Comparison of the effect of intradermal injection of tranexamic acid versus microneedling plus topical tranexamic acid in the treatment of patients with melasma Comparison between the efficacy of multiple microinjections of tranexamic acid (100 mg/ml) with microneedling and topical tranexamic acid (100 mg/ml) in the treatment of melasma in patients with symmetrical face melasma 2020-11-30 anticipated 27 Complete https://irct.ir/trial/52773 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who met the inclusion criteria will randomly divided into two groups using random allocation software, this software creates a random sequence by blocking method. Each patient participating in the study will receive a unique code, and the person performing the randomization with the software will not be informed of any further actions and interventions. After assigning the code the patients will be divided into two groups. The first intervention group will undergo microneedling on the right side of the face and then tranexamic acid will be applied topically. On the left side of the face, an Intradermal injection of the tranexamic solution will be performed. The second intervention group will undergo microneedling on the left side of the face and then tranexamic acid will be applied topically. On the right side of the face, Intradermal injection of the tranexamic solution will be performed. 3 melasma. Intervention 1: Intervention group 1: includes 13 patients whose right side of the face is 100 mg / ml tranexamic acid solution is topically apllied on the skin surface then microneedling (inopen made in USA) is used and the left side of the face is injected 100 mg / ml sterile transaxamic solution Injectable (Daru Pakhsh Company) is done in sections with a distance of 1 cm of tranexamic acid. Medications will be prescribed up to 3 times a month. Intervention 2: Intervention group 2: includes 13 patients whose left side of the face is 100 mg / ml tranexamic acid solution is evenly distributed on the skin surface and immediately microneedling (inopen made in USA) is used and the right side of the face is injected 100 mg / ml sterile transaxamic solution Injectable (Daru Pakhsh Company) is done in sections with a distance of 1 cm of tranexamic acid. Medications will be prescribed up to 3 times a month. Yes - There is a plan to make this available What will be shared: The primary outcome data will be shared. When: Start the access period is 6 months after publishing the results. To whom: Academic researchers Conditions: The request can be made by e-mail to the corresponding author Where to obtain: It can be done by e-mail to maryam.alizadeh87@gmail.com How to obtain: Once the applicant has provided details of their ongoing project within one month from the time of application data will be available. Comments:
public Maryam Alizadeh
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 maryam.alizadeh87@gmail.com Esfahan University of Medical Sciences scientific Maryam Alizadeh
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 maryam.alizadeh87@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Having Fitzpatrick II-IV skin type with symmetrical melasma diagnosed by a dermatologist Patient willingness to participate in the study no limit no limit Both Patients receiving OCP, anticonvulsants, antidepressants, and thyroid medications over the past 12 months Existence of coagulation disorder or anticoagulant use in the patient Patient sensitivity to the studied compounds Existence of active herpes, facial warts or active dermatosis Pregnancy or lactation Treatment - Drugs Treatment - Drugs Intervention group 1: includes 13 patients whose right side of the face is 100 mg / ml tranexamic acid solution is topically apllied on the skin surface then microneedling (inopen made in USA) is used and the left side of the face is injected 100 mg / ml sterile transaxamic solution Injectable (Daru Pakhsh Company) is done in sections with a distance of 1 cm of tranexamic acid. Medications will be prescribed up to 3 times a month. Intervention group 2: includes 13 patients whose left side of the face is 100 mg / ml tranexamic acid solution is evenly distributed on the skin surface and immediately microneedling (inopen made in USA) is used and the right side of the face is injected 100 mg / ml sterile transaxamic solution Injectable (Daru Pakhsh Company) is done in sections with a distance of 1 cm of tranexamic acid. Medications will be prescribed up to 3 times a month. MASI scoring for photographs of patients with melasma. Timepoint: Before the start of the study and 4 weeks after the end of treatment. Method of measurement: MASI score for photography. Patient satisfaction with treatment. Timepoint: 4 weeks after treatment. Method of measurement: questionnaire. Esfahan University of Medical Sciences Approved 2020-11-22 Ethics committee of Isfahan University of Medical Sciences Soffeh Blvd Isfahan Isfehan Iran (Islamic Republic of)