Oral and Topical Tranexamic Acid for the Treatment of Melasma

Melasma Clinical Trial

— TRANEXAMICO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03585179
• Other study ID #: 151/2018
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2018
• Source: Centro Dermatológico Dr. Ladislao de la Pascua
• Contact: Martha A Morales-Sánchez, MD
• Phone: 55387033
• Email: mmoraless[@]sersalud.df.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chloasma
• Melanosis
• Melasma

Intervention

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

Locations

Country	Name	City	State
Mexico	Centro Dermatológico "Dr. Ladislao de la Pascua"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Centro Dermatológico Dr. Ladislao de la Pascua

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks