Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

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

Detailed Description
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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.

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

Conditions
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Melasma

Intervention / Treatment
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* Drug: Tranexamic Acid Oral Product
* Drug: Hydroquinone 4% Cream
* Other: Sunscreen
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study<br>Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks | Drug: Tranexamic Acid Oral Product<br>* Encapsulated tranexamic acid 250 mg<br>* Other names: TA;Drug: Hydroquinone 4% Cream<br>* Hydroquinone 4% Cream<br>* Other names: HQ;Other: Sunscreen<br>* Sunscreen SPF 30<br>* Other names: Sun Protection;|
| Placebo Comparator: Control<br>Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks | Drug: Hydroquinone 4% Cream<br>* Hydroquinone 4% Cream<br>* Other names: HQ;Other: Sunscreen<br>* Sunscreen SPF 30<br>* Other names: Sun Protection;Device: Placebo<br>* Encapsulated placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline mMASI Score at week 12 | 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) | Baseline, week 2, 12, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanin index | 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. | Baseline, week 2, 12, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melasma, tranexamic acid, hydroquinone, mMASI, mexameter