Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Melasma

Treatments: Device: Placebo; Other: Sunscreen; Drug: Hydroquinone 4% Cream; Drug: Tranexamic Acid Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03751163

008

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 21 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Study

Active Comparator group

Description:

Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

Treatment:

Drug: Tranexamic Acid Oral Product

Drug: Hydroquinone 4% Cream

Other: Sunscreen

Control

Placebo Comparator group

Description:

Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

Treatment:

Drug: Hydroquinone 4% Cream

Other: Sunscreen

Device: Placebo