MedTrace Logo

Oral and Topical Tranexamic Acid for the Treatment of Melasma

NCT03585179 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-07-16

No results posted yet for this study

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.

Conditions

  • Melasma
  • Chloasma
  • Melanosis

Interventions

DRUG

Oral Tranexamic Acid

Participants will take a pill of 250 mg bid for 12 weeks

DRUG

5% topical tranexamic acid

Participants will apply a layer of gel on the affected skin bid for 12 weeks

DRUG

4% hydroquinone

Participants will apply a layer of cream on the affected skin once at night

Sponsors & Collaborators

  • Centro Dermatológico Dr. Ladislao de la Pascua

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-12-31
Completion
2020-06-01
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585179 on ClinicalTrials.gov