Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03751163

Enrollment

Registered

2018-11-23

Start date

2016-03-16

Completion date

2017-04-02

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

melasma, tranexamic acid, hydroquinone, mMASI, mexameter

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 plasmin inhibitor, can prevent UV-induced pigmentation.

Interventions

DRUGTranexamic Acid Oral Product

Encapsulated tranexamic acid 250 mg

DRUGHydroquinone 4% Cream

Hydroquinone 4% Cream

OTHERSunscreen

Sunscreen SPF 30

DEVICEPlacebo

Encapsulated placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline mMASI Score at week 12	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

Measure	Time frame	Description
Melanin index	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026