Clinical trial NCT03585179: Oral and Topical Tranexamic Acid for the Treatment of Melasma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Melasma
Chloasma
Melanosis
Keywords: Melasma
Chloasma
Melanosis
Tranexamic acid
Hydroquinone
Therapeutics
Lead sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of mMASI (Modified Melasma Area and Severity Index)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 12 weeks
measure: Melanin index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Dermatológico "Dr. Ladislao de la Pascua"
Study officials:
affiliation: Centro Dermatológico Dr. Ladislao de la Pascua
name: Martha A Morales-Sánchez, MD
role: STUDY_DIRECTOR
References: