Status:

COMPLETED

Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Lead Sponsor:

Fakultas Kedokteran Universitas Indonesia

Conditions:

Melasma

Eligibility:

FEMALE

21-64 years

Phase:

PHASE3

Brief Summary

This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

Detailed Description

Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment. Recent studies have shown that tranexamic acid, a pla...

Eligibility Criteria

Inclusion

  • moderate melasma (subject with mMASI score of 5 to 7.9),
  • severe melasma (subject with mMASI score ≥ 8),
  • willing to follow up for 6 months.

Exclusion

  • pregnant women,
  • nursing women,
  • women on exogenous hormones
  • current treatment with blood thinners,
  • had a history of thrombosis,
  • had an abnormal kidney function,
  • use of topical hydroquinone within 3 months of study enrollment,
  • use of topical steroids, vitamin A analogs, chemical peels within 1 month of study

Key Trial Info

Start Date :

March 16 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 2 2017

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03751163

Start Date

March 16 2016

End Date

April 2 2017

Last Update

November 26 2018

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Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma | DecenTrialz