drugset / Trial / NCT03585179

Oral and Topical Tranexamic Acid for the Treatment of Melasma

NCT03585179

RandomizedParallel-groupTriple-blindTreatment

Summary

Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

Timeline

Start
2018-08-01
Primary completion
2019-12-31
Completion
2020-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydroquinone Small molecule 4 % Topical
Subject Tranexamic Acid Small molecule 5 % Oral
Subject Tranexamic Acid Small molecule 250 mg Oral