BACKGROUND:Melasma poses a great challenge as its treatment is unsatisfactory and recurrence is high. Treatment of melasma using tranexamic acid (oral, topical or intralesional) is a novel concept. OBJECTIVE: To compare the efficacy of oral tranexamic acid with routine topical therapies for the treatment of melasma. METHODS: It is a prospective, interventional, randomized controlled trial conducted among 260 melasma patients. Patients were divided into two groups consisting of 130 patients each. First group (Group A) was given routine treatment measures and oral Tranexamic Acid while second group (Group B) was treated only with routine topical measures. Capsule Tranexamic Acid was prescribed at a dose of 250 mg twice a day for three months and cases were followed for three months. Response was evaluated on the basis of Melasma Assessment Severity Index (MASI). Mean scores between the two groups were then compared. RESULTS: Statistically significant decrease in the mean Melasma Assessment Severity Index from baseline to 8 and 12 weeks was observed among group A patients (11.08±2.91 vs 8.95±2.08 at week 8 and vs. 7.84±2.44 at week 12; p<0.05 for both). While among group B patients the decrease in mean score was significant at 8 weeks and insignificant at 12 weeks follow up (11.60±3.40 vs 9.9±2.61 at 8 weeks and vs. 9.26±3 at 12 weeks; p<0.05 for former but p>0.05 for later). CONCLUSION: Addition of oral tranexamic acid provides rapid and sustained improvement in the treatment of melasma.
RCT Entities:
BACKGROUND: Melasma poses a great challenge as its treatment is unsatisfactory and recurrence is high. Treatment of melasma using tranexamic acid (oral, topical or intralesional) is a novel concept. OBJECTIVE: To compare the efficacy of oral tranexamic acid with routine topical therapies for the treatment of melasma. METHODS: It is a prospective, interventional, randomized controlled trial conducted among 260 melasma patients. Patients were divided into two groups consisting of 130 patients each. First group (Group A) was given routine treatment measures and oral Tranexamic Acid while second group (Group B) was treated only with routine topical measures. Capsule Tranexamic Acid was prescribed at a dose of 250 mg twice a day for three months and cases were followed for three months. Response was evaluated on the basis of Melasma Assessment Severity Index (MASI). Mean scores between the two groups were then compared. RESULTS: Statistically significant decrease in the mean Melasma Assessment Severity Index from baseline to 8 and 12 weeks was observed among group A patients (11.08±2.91 vs 8.95±2.08 at week 8 and vs. 7.84±2.44 at week 12; p<0.05 for both). While among group B patients the decrease in mean score was significant at 8 weeks and insignificant at 12 weeks follow up (11.60±3.40 vs 9.9±2.61 at 8 weeks and vs. 9.26±3 at 12 weeks; p<0.05 for former but p>0.05 for later). CONCLUSION: Addition of oral tranexamic acid provides rapid and sustained improvement in the treatment of melasma.
Authors: Lei Zhang; Wei-Qiang Tan; Qing-Qing Fang; Wan-Yi Zhao; Qi-Ming Zhao; Jie Gao; Xiao-Wei Wang Journal: Biomed Res Int Date: 2018-11-06 Impact factor: 3.411