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Completed

NCT Number: NCT03751163

Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

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

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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 plasmin inhibitor, can prevent UV-induced pigmentation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Tranexamic Acid Oral Product

Drug

Encapsulated tranexamic acid 250 mg

Other names: TA

Hydroquinone 4% Cream

Drug

Hydroquinone 4% Cream

Other names: HQ

Sunscreen

Other

Sunscreen SPF 30

Other names: Sun Protection

PLACEBO

Device

Encapsulated placebo

Primary outcomes

  1. Change from Baseline mMASI Score at week 12

    Time frame: Baseline, week 2, 12, 24

    modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin)

    Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent;

    1, <10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face.

    Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD)

Secondary outcomes

  1. Melanin index

    Time frame: Baseline, week 2, 12, 24

    difference in pigmentation readings between involved and adjacent uninvolved skin, was measured using a mexameter.

    Mexameter is a simple, rapid, and completely non-invasive instrument which measures skin pigmentation. The device has a probe which is gently pressed on the skin and painlessly records the level of pigmentation using a range of 1-1000, with 1 corresponding to white and 1000 to black.

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study title

Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2018
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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