Oral and Topical Tranexamic Acid for the Treatment of Melasma

Phase 3

• Conditions: Melasma; Chloasma; Melanosis
• Interventions: Drug: Oral Tranexamic Acid; Drug: 5% topical tranexamic acid; Drug: 4% hydroquinone

• Registration Number: NCT03585179
• Lead Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua

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.

Study Timeline

• Study First Submitted: 2018-06-29
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-12
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16
• Study Start: 2018-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral tranexamic acid	Oral Tranexamic Acid	250 mg of tranexamic acid bid orally
Topical tranexamic acid	5% topical tranexamic acid	5% topical tranexamic acid bid
Topical hydroquinone	4% hydroquinone	4% hydroquinone once daily at night

Primary Outcome Measures

Name	Time	Method
Change of mMASI (Modified Melasma Area and Severity Index)	12 weeks	The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life	12 weeks	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.
Melanin index	12 weeks	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.

Trial Locations

Locations (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"; 🇲🇽 Mexico City, Mexico