Oral and Topical Tranexamic Acid for the Treatment of Melasma

Centro Dermatológico Dr. Ladislao de la Pascua120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Melasma Chloasma Melanosis

Interventions

Oral Tranexamic AcidDRUG

Participants will take a pill of 250 mg bid for 12 weeks

5% topical tranexamic acidDRUG

Participants will apply a layer of gel on the affected skin bid for 12 weeks

4% hydroquinoneDRUG

Participants will apply a layer of cream on the affected skin once at night

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age older than 18 years * Moderate to severe melasma * History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI \<50% reported by the dermatologist after one year of treatment. Exclusion Criteria: * Pregnancy * Hormonal contraception * Lactation * Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months * Endocrinology diseases * Hormone replacement therapy * Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders * Mental disability

Locations (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"

Mexico City, Mexico

Outcomes

Primary Outcomes

Change of mMASI (Modified Melasma Area and Severity Index)

The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12

Time frame: 12 weeks

Secondary Outcomes

Change in Quality of life

The reported change of the score of DLQI (Dermatology Life Quality Index) at week 0 versus week 12. Total score ranges from 0 to 30 and the difference between the score at week 0 and week 12 will be calculated.

Time frame: 12 weeks

Melanin index

The difference between melanin index at week 0 versus week 12. The melanin index will be measure with Mexameter® MX 18. Total index ranges from 0 to 999.

Time frame: 12 weeks

Central Contacts

Martha A Morales-Sánchez, MD

CONTACT

55387033 mmoraless@sersalud.df.gob.mx

Data from ClinicalTrials.gov

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