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IRCT20220709055422N1 IRCT 2022-07-17 Pak-Emirates Military Hospital Rawalpindi Efficacy of Tranexamic Acid Versus Topical 4% Hydroquinone in Melasma Comparison of Efficacy of Intralesional Tranexamic Acid Versus Topical 4% Hydroquinone in Treating Melasma 2018-10-16 anticipated 290 Complete https://irct.ir/trial/64681 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using block design, we randomized the data. Randomization was 1:1 for Group A and Group B, i.e. each upcoming individual was included in the next group; this randomization was supervised by another clinician. Sample size for Group A (intralesional tranexamic acid) was 145 while sample size for Group B (topical 4% hydroquinone) was 145. 3 Melasma .. Intervention 1: Intervention group: Patients received weekly intradermal injections of 0.5 ml Tranexamic acid in 0.5 ml normal saline (50 mg/ml) into the melasma lesion at 1 cm intervals using a sterile insulin syringe. Intervention 2: Intervention group 2: Patients in intervention Group 2 were given a topical hydroquinone 4% cream to apply to the relevant area at night for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line. Patients who lost to follow up were contacted through their contact numbers and were reminded for their follow up visit. 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 The team has applied for making the data available with the institute where the study was conducted. The institute will make a decision after following its set of protocols to make the data available
public Dr Muhammad Rizwan
PEMH Hospital Rawalpindi Cantonment
Rawalpindi Pakistan 46000 +92 333 5373829 rizwan_rawalian2000@gmail.com Pak-Emirates Military Hospital Rawalpindi scientific Dr Muhammad Rizwan
PEMH Hospital Rawalpindi Cantonment
Rawalpindi Pakistan 46000 +92 333 5373829 rizwan_rawalian2000@gmail.com PEMH Rawalpindi Pakistan patients suffering from melasma 18 years no limit Female history of discoid lupus erythematosus pregnancy lactation anemia oral contraceptives or hormone replacement therapy L81.1 L81.1 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. The 2022 edition of ICD-10-CM L81.1 became effective on October 1, 2021.This is the American ICD-10-CM version of L81.1 - other international Treatment - Drugs Treatment - Drugs Intervention group: Patients received weekly intradermal injections of 0.5 ml Tranexamic acid in 0.5 ml normal saline (50 mg/ml) into the melasma lesion at 1 cm intervals using a sterile insulin syringe. Intervention group 2: Patients in intervention Group 2 were given a topical hydroquinone 4% cream to apply to the relevant area at night for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line. Patients who lost to follow up were contacted through their contact numbers and were reminded for their follow up visit. Efficacy was evaluated on the basis of fall in MASI score for Melasma from base line. Timepoint: Interventions were Offred for a period of 12 weeks. Follow up was done at 4 weekly intervals for 12 weeks. After 12 weeks final response was assessed. All patients were called for follow up and efficacy was evaluated on the basis of fall in MASI score from base line. Method of measurement: MASI score was measured by a trained physician on each visit. Pak-Emirates Military Hospital Rawalpindi Approved 2018-06-10 Pak-Emirates Military Hospital Rawalpindi Ethical and Institutional Review Committee PEMH Hospital Rawalpindi Cantonment Rawalpindi Punjab Pakistan