NCT03585179

Oral and Topical Tranexamic Acid for the Treatment of Melasma

Oral and 5% Topical Tranexamic Acid in Monotherapy Compared With 4% Topical Hydroquinone for the Treatment of Melasma: Three-arm Randomized, Double-blinded Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. 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.

Conditions

• Melasma
• Chloasma
• Melanosis

Interventions

Type	Name	Description
DRUG	Oral Tranexamic Acid	Participants will take a pill of 250 mg bid for 12 weeks
DRUG	5% topical tranexamic acid	Participants will apply a layer of gel on the affected skin bid for 12 weeks
DRUG	4% hydroquinone	Participants will apply a layer of cream on the affected skin once at night

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-12-31
• Completion: 2020-06-01
• First posted: 2018-07-12
• Last updated: 2018-07-16

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study