Oral and Topical Tranexamic Acid for the Treatment of Melasma (TRANEXAMICO)

Centro Dermatológico Dr. Ladislao de la Pascua

Status and phase: Unknown; Phase 3

Conditions: Chloasma; Melasma; Melanosis

Treatments: Drug: 5% topical tranexamic acid; Drug: Oral Tranexamic Acid; Drug: 4% hydroquinone

Study type: Interventional

Funder types: Other

Identifiers

NCT03585179

151/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Oral tranexamic acid

Experimental group

Description:

250 mg of tranexamic acid bid orally

Treatment:

Drug: Oral Tranexamic Acid

Topical tranexamic acid

Experimental group

Description:

5% topical tranexamic acid bid

Treatment:

Drug: 5% topical tranexamic acid

Topical hydroquinone

Active Comparator group

Description:

4% hydroquinone once daily at night

Treatment:

Drug: 4% hydroquinone