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

July 12, 2018 updated by: Centro Dermatológico Dr. Ladislao de la Pascua

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06780
        • Centro Dermatológico "Dr. Ladislao de la Pascua"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral tranexamic acid
250 mg of tranexamic acid bid orally
Drug: Oral Tranexamic Acid
Participants will take a pill of 250 mg bid for 12 weeks
Experimental: Topical tranexamic acid
5% topical tranexamic acid bid
Drug: 5% topical tranexamic acid
Participants will apply a layer of gel on the affected skin bid for 12 weeks
Other Names:
  • Topical tranexamic acid
Active Comparator: Topical hydroquinone
4% hydroquinone once daily at night
Drug: 4% hydroquinone
Participants will apply a layer of cream on the affected skin once at night
Other Names:
  • Hydroquinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of mMASI (Modified Melasma Area and Severity Index)
Time Frame: 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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life
Time Frame: 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.
12 weeks
Melanin index
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Dermatológico Dr. Ladislao de la Pascua

Investigators

  • Study Director: Martha A Morales-Sánchez, MD, Centro Dermatológico Dr. Ladislao de la Pascua

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only if researchers ask for the complete data of the trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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