Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Phase 3

Completed

• Conditions: Melasma
• Interventions: Drug: Tranexamic Acid Oral Product; Other: Sunscreen; Drug: Hydroquinone 4% Cream; Device: Placebo

• Registration Number: NCT03751163
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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.

Study Timeline

• Study Start: 2016-03-16
• Primary Completion: 2017-04-02
• Study Completion: 2017-04-02
• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-21
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sunscreen	Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Study	Tranexamic Acid Oral Product	Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Study	Hydroquinone 4% Cream	Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Study	Sunscreen	Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Control	Hydroquinone 4% Cream	Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Control	Placebo	Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.